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Clinical Trial Results:
A phase 1, Open-Label Dose-Finding Study to Evaluate Safety, Tolerability, and Immunogenicity and Phase 2/3 Placebo-Controlled, Observer-Blinded Safety, Tolerability, and Immunogenicity Study of a SARS-COV-2 RNA Vaccine Candidate Against COVID-19 in Healthy Children

Summary
EudraCT number	2020-005442-42
Trial protocol	FI   PL
Global end of trial date	08 Dec 2023
Results information
Results version number	v1(current)
This version publication date	21 Jun 2024
First version publication date	21 Jun 2024
Other versions

Trial information Top of page
Trial identification
Sponsor protocol code	C4591007
Additional study identifiers
ISRCTN number	-
US NCT number	NCT04816643
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	BioNTech SE
Sponsor organisation address	An der Goldgrube 12, Mainz, Germany, 55131
Public contact	BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
Scientific contact	BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	Yes
EMA paediatric investigation plan number(s)	EMEA-002861-PIP02-20
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	Yes
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	05 Jan 2024
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	08 Dec 2023
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	Phase 1: To describe the safety and tolerability profiles of prophylactic BNT162b2 at each dose level in each age group. Phase 2/3: To define the safety profile of prophylactic BNT162b2 in all participants (selected-dose and obtaining-serum-samples-for potential- troponin I-testing portions of the study) in each age group. To immunobridge the immune response elicited by prophylactic BNT162b2 between Phase 2/3 participants at the dose selected in each age group and participants 16 to 25 years of age from the C4591001 study without serological or virological evidence (up to 1 month after receipt of Dose 2) of past SARS-CoV-2 infection. To immunobridge the immune response elicited by prophylactic BNT162b2 between Phase 2/3 participants at the dose selected in each age group and participants 16 to 25 years of age from the C4591001 study without serological or virological evidence (up to 1 month after receipt of Dose 3) of past SARS-CoV-2 infection.
Protection of trial subjects	The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	24 Mar 2021
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	Yes
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	United States: 9608
Country: Number of subjects enrolled	Mexico: 353
Country: Number of subjects enrolled	Spain: 413
Country: Number of subjects enrolled	Brazil: 262
Country: Number of subjects enrolled	Finland: 414
Country: Number of subjects enrolled	Poland: 691
Worldwide total number of subjects	11741
EEA total number of subjects	1518
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	2192
Children (2-11 years)	9062
Adolescents (12-17 years)	487
Adults (18-64 years)	0
From 65 to 84 years	0
85 years and over	0

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	The study consisted of 2 parts, Phase 1 and Phase 2/3. The overall baseline period presented below was created to support display of the demographic characteristics for all study phases. The complete disposition information is presented below in separate tables for each individual phase, respectively.
Pre-assignment
Screening details	Out of 11837 participants enrolled, 11836 were randomized. However, one participant was enrolled in error and assigned to treatment, of which 11741 were vaccinated.
Period 1
Period 1 title	Baseline Period
Is this the baseline period?	Yes
Allocation method	Not applicable
Blinding used	Not blinded
Arms
Are arms mutually exclusive	Yes
Arm title	Phase 1:BNT162b2 (3 mcg):6 Months to < 2 years of age
Arm description	Participants aged 6 months to less than (<) 2 years of age received 2 doses of 3 microgram (mcg) BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age
Arm description	Participants aged 2 to <5 years of age received 2 doses of 3 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age
Arm description	Participants aged 2 to <5 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age
Arm description	Participants aged 5 to <12 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age
Arm description	Participants aged 5 to <12 years of age received 2 doses of 20 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 2 doses of 20 mcg and 1 dose of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: 5 to <12 Years 30/30 mcg
Arm description	Participants aged 5 to <12 years of age received 2 doses of 30 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 2 doses of 30 mcg and 1 dose of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: 5 to <12 Years 30/10 mcg
Arm description	Participants aged 5 to <12 years of age received 30 mcg in dose 1 and 10 mcg in dose 2 of BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 30 mcg in dose 1 and 10 mcg in dose 2 of BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age
Arm description	Participants aged 6 months to <2 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: Placebo: 6 months to <2 years of age
Arm description	Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Arm type	Experimental
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly separated by 21 days interval as part of this study.
Arm title	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age
Arm description	Participants aged 2 to <5 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: Placebo: 2 to <5 years of age
Arm description	Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly separated by 21 days interval as part of this study.
Arm title	Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age
Arm description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: Placebo: 5 to <12 years of age
Arm description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly separated by 21 days interval as part of this study.
Arm title	Phase 2/3:Troponin group:BNT162b2(10 mcg):5 to<12 years of age
Arm description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: Troponin group: Placebo: 5 to <12 years of age
Arm description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly separated by 21 days interval as part of this study.
Arm title	Phase 2/3:Troponin group:BNT162b2(30 mcg):12 to<16years of age
Arm description	Participants aged 12 to <16 years received 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 30 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 30 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Number of subjects in period 1 Phase 1:BNT162b2 (3 mcg):6 Months to < 2 years of age Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1: 5 to <12 Years 30/30 mcg Phase 1: 5 to <12 Years 30/10 mcg Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years of age Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Phase 2/3:Troponin group:BNT162b2(10 mcg):5 to<12 years of age Phase 2/3: Troponin group: Placebo: 5 to <12 years of age Phase 2/3:Troponin group:BNT162b2(30 mcg):12 to<16years of age Started 16 16 32 16 16 4 12 1458 718 2368 1173 3109 1538 518 260 487 Completed 16 16 32 16 16 4 12 1458 718 2368 1173 3109 1538 518 260 487
Period 2
Period 2 title	Phase 1
Is this the baseline period?	No
Allocation method	Not applicable
Blinding used	Not blinded
Arms
Are arms mutually exclusive	Yes
Arm title	Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age
Arm description	Participants aged 6 months to less than (<) 2 years of age received 2 doses of 3 microgram (mcg) BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age
Arm description	Participants aged 2 to <5 years of age received 2 doses of 3 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age
Arm description	Participants aged 2 to <5 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age
Arm description	Participants aged 5 to <12 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age
Arm description	Participants aged 5 to <12 years of age received 2 doses of 20 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 2 doses of 20 mcg and 1 dose of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age
Arm description	Participants aged 5 to <12 years of age received 2 doses of 30 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 2 doses of 30 mcg and 1 dose of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age
Arm description	Participants aged 5 to <12 years of age received 30 mcg in dose 1 and 10 mcg in dose 2 of BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 30 mcg in dose 1 and 10 mcg in dose 2 of BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Number of subjects in period 2 [1] Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age Started 16 16 32 16 16 4 12 Completed 8 7 14 2 3 2 1 Not completed 8 9 18 14 13 2 11      Withdrawal by parent/guardian/subject 1 3 4 1 2 - 1      Unspecified 6 3 4 8 2 1 4      Lost to follow-up - 1 2 - - - -      Protocol deviation 1 2 8 5 9 1 6
Notes [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period. Justification: The participants enrolled in both periods are different.
Period 3
Period 3 title	Phase 2/3
Is this the baseline period?	No
Allocation method	Randomised - controlled
Blinding used	Double blind
Roles blinded	Subject, Investigator
Arms
Are arms mutually exclusive	No
Arm title	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age
Arm description	Participants aged 6 months to <2 years were randomized to received 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: Placebo: 6 months to <2 years
Arm description	Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly.
Arm title	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age
Arm description	Participants aged 2 to <5 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 3 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: Placebo: 2 to <5 years of age
Arm description	Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly separated by 21 days interval as part of this study.
Arm title	Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age
Arm description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3: Placebo: 5 to <12 years of age
Arm description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly separated by 21 days interval as part of this study.
Arm title	Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years
Arm description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 10 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Arm title	Phase 2/3:Troponin group:Placebo:5 to <12 years
Arm description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Arm type	Placebo
Investigational medicinal product name	Placebo
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received normal saline (0.9% sodium chloride solution for injection) administered intramuscularly separated by 21 days interval as part of this study.
Arm title	Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years
Arm description	Participants aged 12 to <16 years were received 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 30 mcg BNT162b2 approximately 175 days after vaccination 2.
Arm type	Experimental
Investigational medicinal product name	BNT162b2
Investigational medicinal product code
Other name
Pharmaceutical forms	Injection
Routes of administration	Intramuscular use
Dosage and administration details	Participants received 3 doses of 30 mcg BNT162b2 RNA-LNP vaccine utilizing modRNA (100 microgram/milliliter) administered intramuscularly.
Number of subjects in period 3 Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Started 1458 718 2368 1173 3109 1538 518 260 487 Completed 712 261 1215 406 1604 636 395 188 424 Not completed 746 457 1153 767 1505 902 123 72 63      Withdrawal by parent/guardian/subject 199 196 427 458 816 543 66 37 40      Physician decision 3 1 2 1 - - 1 1 -      Refused further study procedures - - - - 2 - - - -      Pregnancy - - - - - - - - 2      Adverse event 1 - 3 - - - - - -      Unspecified 465 221 464 171 86 47 11 4 -      Lost to follow-up 53 23 109 55 126 41 14 10 15      Protocol deviation 25 16 148 82 475 271 31 20 6

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Phase 1:BNT162b2 (3 mcg):6 Months to < 2 years of age
Reporting group description	Participants aged 6 months to less than (<) 2 years of age received 2 doses of 3 microgram (mcg) BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years of age received 2 doses of 3 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 20 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: 5 to <12 Years 30/30 mcg
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 30 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: 5 to <12 Years 30/10 mcg
Reporting group description	Participants aged 5 to <12 years of age received 30 mcg in dose 1 and 10 mcg in dose 2 of BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age
Reporting group description	Participants aged 6 months to <2 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 6 months to <2 years of age
Reporting group description	Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3:Troponin group:BNT162b2(10 mcg):5 to<12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: Troponin group: Placebo: 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3:Troponin group:BNT162b2(30 mcg):12 to<16years of age
Reporting group description	Participants aged 12 to <16 years received 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 30 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group values Phase 1:BNT162b2 (3 mcg):6 Months to < 2 years of age Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1: 5 to <12 Years 30/30 mcg Phase 1: 5 to <12 Years 30/10 mcg Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years of age Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Phase 2/3:Troponin group:BNT162b2(10 mcg):5 to<12 years of age Phase 2/3: Troponin group: Placebo: 5 to <12 years of age Phase 2/3:Troponin group:BNT162b2(30 mcg):12 to<16years of age Total Number of subjects 16 16 32 16 16 4 12 1458 718 2368 1173 3109 1538 518 260 487 11741 Age Categorical Units: Participants     In utero 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Preterm newborn infants (gestational age < 37 wks) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Newborns (0-27 days) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Infants and toddlers (28 days-23 months) 16 0 0 0 0 0 0 1458 718 0 0 0 0 0 0 0 2192     Children (2-11 years) 0 16 32 16 16 4 12 0 0 2368 1173 3109 1538 518 260 0 9062     Adolescents (12-17 years) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 487 487     Adults (18-64 years) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     From 65-84 years 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     85 years and over 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Gender Categorical Units: Participants     Female 6 7 13 11 6 1 6 728 372 1197 570 1500 759 252 120 216 5764     Male 10 9 19 5 10 3 6 730 346 1171 603 1609 779 266 140 271 5977 Race Units: Subjects     White 13 12 25 11 13 4 10 1126 562 1870 913 2404 1199 425 219 228 9034     Black or African American 0 0 2 3 0 0 0 73 34 138 71 179 101 19 11 40 671     Asian 1 1 2 2 2 0 1 101 51 147 92 256 118 49 16 4 843     Multiracial 2 3 2 0 1 0 1 149 65 189 86 235 106 23 13 1 876     American Indian or Alaska Native 0 0 1 0 0 0 0 4 1 4 4 13 4 1 1 209 242     Native Hawaiian or other Pacific Islander 0 0 0 0 0 0 0 0 0 2 1 10 0 0 0 0 13     Not reported 0 0 0 0 0 0 0 5 5 18 6 12 10 1 0 5 62 Ethnicity Units: Subjects     Hispanic/Latino 3 0 1 2 0 2 0 248 93 426 193 526 265 52 34 422 2267     Non-Hispanic/non-Latino 13 16 31 14 16 2 12 1205 620 1934 979 2579 1273 466 226 65 9451     Not reported 0 0 0 0 0 0 0 5 5 8 1 4 0 0 0 0 23

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Phase 1:BNT162b2 (3 mcg):6 Months to < 2 years of age
Reporting group description	Participants aged 6 months to less than (<) 2 years of age received 2 doses of 3 microgram (mcg) BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years of age received 2 doses of 3 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 20 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: 5 to <12 Years 30/30 mcg
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 30 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: 5 to <12 Years 30/10 mcg
Reporting group description	Participants aged 5 to <12 years of age received 30 mcg in dose 1 and 10 mcg in dose 2 of BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age
Reporting group description	Participants aged 6 months to <2 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 6 months to <2 years of age
Reporting group description	Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3:Troponin group:BNT162b2(10 mcg):5 to<12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: Troponin group: Placebo: 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3:Troponin group:BNT162b2(30 mcg):12 to<16years of age
Reporting group description	Participants aged 12 to <16 years received 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 30 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age
Reporting group description	Participants aged 6 months to less than (<) 2 years of age received 2 doses of 3 microgram (mcg) BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years of age received 2 doses of 3 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 10 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 20 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 2 doses of 30 mcg BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age
Reporting group description	Participants aged 5 to <12 years of age received 30 mcg in dose 1 and 10 mcg in dose 2 of BNT162b2 vaccine intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age
Reporting group description	Participants aged 6 months to <2 years were randomized to received 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 6 months to <2 years
Reporting group description	Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
Reporting group title	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years were randomised to receive 2 doses of 3 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 3 mcg BNT162b2 approximately 60 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 2 to <5 years of age
Reporting group description	Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3: Placebo: 5 to <12 years of age
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years
Reporting group description	Participants aged 5 to <12 years were randomised to receive 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 10 mcg BNT162b2 approximately 175 days after vaccination 2.
Reporting group title	Phase 2/3:Troponin group:Placebo:5 to <12 years
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly separated by 21 days interval as part of this study.
Reporting group title	Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years
Reporting group description	Participants aged 12 to <16 years were received 2 doses of 10 mcg BNT162b2 intramuscularly separated by 21 days interval as part of this study. Participants received third dose of 30 mcg BNT162b2 approximately 175 days after vaccination 2.
Subject analysis set title	Phase 1: 5 to <12 Years BNT162b2 10 mcg
Subject analysis set type	Per protocol
Subject analysis set description	Participants aged 5 to <12 years who received the third dose of 10 mcg BNT162b2 as part of this study were included.
Subject analysis set title	Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Subject analysis set type	Per protocol
Subject analysis set description	Participants aged 16 to 25 years from study C4591001 (NCT04816643) who received 2 doses of original BNT162b2 30 mcg were included.
Subject analysis set title	Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 3 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	Participants aged 2 to <5 years at the time of receiving third dose received 3 mcg BNT162b2intramuscularly as part of this study.
Subject analysis set title	Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 10 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	Participants in the 2 to < 5years of age group who aged up to 5 years at the time of the 3rd dose received the age-appropriate dose of 10 mcg BNT162b2 intramuscularly.
Subject analysis set title	Phase 2/3: BNT162b2 (10 mcg) 3-Dose Set
Subject analysis set type	Sub-group analysis
Subject analysis set description	Participants aged 5 to <12 years who received Dose 3 and completed 1 month post-Dose 3 visit in the Dose 3 evaluable immunogenicity population without evidence of prior infection up 1 month post-Dose 3 were included.
Subject analysis set title	Phase 2/3: BNT162b2 30 mcg 16-25 Years
Subject analysis set type	Per protocol
Subject analysis set description	Participants aged >=12 to <16 years who received 3 doses of original BNT162b2 30 mcg were included.
Subject analysis set title	Phase 2/3: C4591001: Placebo 16-25 Years
Subject analysis set type	Per protocol
Subject analysis set description	Participants aged >=12 to <16 years who received placebo in Phase 2/3 were included.
Subject analysis set title	Ph2/3:BNT162b2 3mcg:6M-<5Y:WoEI:evaluable efficacy(3dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Phase 2/3 (Ph2/3):Participants aged >=6 months to <5 years (6M-<5Y) in evaluable efficacy (3-Dose) population who received 3 doses of original BNT162b2 3 mcg during the blinded follow up period without evidence of infection(WoEI) prior to 7 days after Dose 3.
Subject analysis set title	Phase2/3:Placebo:6M-<5Y):WoEI:evaluable efficacy(3-dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Participants aged >=6 months to <5 years in evaluable efficacy (3-Dose) population who received 3 doses of placebo during the blinded follow up period without evidence of infection prior to 7 days after Dose 3.
Subject analysis set title	Phase 2/3:BNT162b2 3 mcg 6M<5Y:evaluable efficacy(3-dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Participants aged >=6 months to <5 years in evaluable efficacy (3-Dose) population who received 3 doses of original BNT162b2 3 mcg during the blinded follow up period with and without evidence of infection prior to 7 days after Dose 3.
Subject analysis set title	Phase 2/3:Placebo 6M-<5Y:evaluable efficacy(3-dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Participants aged >=6 months to <5 years in evaluable efficacy (3-Dose) population who received 3 doses of placebo during the blinded follow up period with and without evidence of infection prior to 7 days after Dose 3.
Subject analysis set title	Ph2/3:BNT162b2 3 mcg 5-<12Y:WoEI:evaluable efficacy(3-dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Phase 2/3(Ph2/3):Participants aged 5 to <12 years in evaluable efficacy (3-Dose) population who received 3 doses of original BNT162b2 3 mcg during the blinded follow up period without evidence of infection (WoEI)prior to 7 days after Dose 3.
Subject analysis set title	Phase 2/3:Placebo 5 to <12Y:WoEI:evaluable efficacy(3-dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Participants aged 5 to <12 years in evaluable efficacy (3-Dose) population who received 3 doses of placebo during the blinded follow up period without evidence of infection prior to 7 days after Dose 3.
Subject analysis set title	Phase 2/3:BNT162b2 3 mcg 5-<12Y:evaluable efficacy(3-dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Participants aged 5 to <12 years in evaluable efficacy (3-Dose) population who received 3 doses of original BNT162b2 3 mcg during the blinded follow up period with and without evidence of infection prior to 7 days after Dose 3.
Subject analysis set title	Phase 2/3:Placebo 5-<12Y:evaluable efficacy(3-dose)set
Subject analysis set type	Full analysis
Subject analysis set description	Participants aged 5 to <12 years in evaluable efficacy (3-Dose) population who received 3 doses of placebo during the blinded follow up period with and without evidence of infection prior to 7 days after Dose 3.

End points Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of age [1]
End point description	Local reactions were collected in electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after Dose 1. Redness and swelling were measured and recorded in measuring device unit (mdu) where, 1 mdu =0.5 centimeter(cm) & were graded as mild(>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe(>7.0 cm)& Grade 4 (G4) (necrosis[redness and swelling]or exfoliative dermatitis[redness]).Pain at injection site was graded as mild(did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity) & G4 Emergency room (ER) visit or hospitalisation).G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% Confidence interval was based on Clopper and Pearson method. Safety population consisted of all participants who received at least 1 dose of study intervention.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age Number of subjects analysed 16 16 4 12 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 12.5 (1.6 to 38.3) 0 (0.0 to 20.6) 100.0 (39.8 to 100.0) 16.7 (2.1 to 48.4)     Redness: Mild 6.3 (0.2 to 30.2) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     Redness: Moderate 6.3 (0.2 to 30.2) 0 (0.0 to 20.6) 75.0 (19.4 to 99.4) 16.7 (2.1 to 48.4)     Redness: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Redness: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Swelling: Any 18.8 (4.0 to 45.6) 6.3 (0.2 to 30.2) 50.0 (6.8 to 93.2) 8.3 (0.2 to 38.5)     Swelling: Mild 6.3 (0.2 to 30.2) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     Swelling: Moderate 12.5 (1.6 to 38.3) 6.3 (0.2 to 30.2) 25.0 (0.6 to 80.6) 8.3 (0.2 to 38.5)     Swelling: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Swelling: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Pain at the injection site: Any 87.5 (61.7 to 98.4) 93.8 (69.8 to 99.8) 100.0 (39.8 to 100.0) 83.3 (51.6 to 97.9)     Pain at the injection site: Mild 68.8 (41.3 to 89.0) 56.3 (29.9 to 80.2) 50.0 (6.8 to 93.2) 50.0 (21.1 to 78.9)     Pain at the injection site: Moderate 18.8 (4.0 to 45.6) 37.5 (15.2 to 64.6) 50.0 (6.8 to 93.2) 33.3 (9.9 to 65.1)     Pain at the injection site: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Pain at the injection site: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of age [2]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalisation. G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age Number of subjects analysed 16 16 4 12 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 37.5 (15.2 to 64.6) 18.8 (4.0 to 45.6) 75.0 (19.4 to 99.4) 16.7 (2.1 to 48.4)     Redness: Mild 25.0 (7.3 to 52.4) 6.3 (0.2 to 30.2) 25.0 (0.6 to 80.6) 8.3 (0.2 to 38.5)     Redness: Moderate 12.5 (1.6 to 38.3) 12.5 (1.6 to 38.3) 25.0 (0.6 to 80.6) 8.3 (0.2 to 38.5)     Redness: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     Redness: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Swelling: Any 31.3 (11.0 to 58.7) 18.8 (4.0 to 45.6) 50.0 (6.8 to 93.2) 0 (0.0 to 26.5)     Swelling: Mild 12.5 (1.6 to 38.3) 0 (0.0 to 20.6) 50.0 (6.8 to 93.2) 0 (0.0 to 26.5)     Swelling: Moderate 18.8 (4.0 to 45.6) 18.8 (4.0 to 45.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Swelling: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Swelling: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Pain at the injection site: Any 87.5 (61.7 to 98.4) 75.0 (47.6 to 92.7) 100.0 (39.8 to 100.0) 91.7 (61.5 to 99.8)     Pain at the injection site: Mild 75.0 (47.6 to 92.7) 50.0 (24.7 to 75.3) 50.0 (6.8 to 93.2) 83.3 (51.6 to 97.9)     Pain at the injection site: Moderate 12.5 (1.6 to 38.3) 25.0 (7.3 to 52.4) 50.0 (6.8 to 93.2) 8.3 (0.2 to 38.5)     Pain at the injection site: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Pain at the injection site: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of age [3]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and G4 ER visit or hospitalisation. Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. All participants aged 5 to <12 years were administered BNT 10 mcg at Dose 3; hence, only BNT 10 mcg arm is reported.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: 5 to <12 Years BNT162b2 10 mcg Number of subjects analysed 38 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 28.9 (15.4 to 45.9)     Redness: Mild 21.1 (9.6 to 37.3)     Redness: Moderate 7.9 (1.7 to 21.4)     Redness: Severe 0 (0.0 to 9.3)     Redness: Grade 4 0 (0.0 to 9.3)     Swelling: Any 13.2 (4.4 to 28.1)     Swelling: Mild 10.5 (2.9 to 24.8)     Swelling: Moderate 2.6 (0.1 to 13.8)     Swelling: Severe 0 (0.0 to 9.3)     Swelling: Grade 4 0 (0.0 to 9.3)     Pain at the injection site: Any 86.8 (71.9 to 95.6)     Pain at the injection site: Mild 68.4 (51.3 to 82.5)     Pain at the injection site: Moderate 18.4 (7.7 to 34.3)     Pain at the injection site: Severe 0 (0.0 to 9.3)     Pain at the injection site: Grade 4 0 (0.0 to 9.3)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of age [4]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Fever:oral temperature >= 38.0 degree Celsius (deg C);categorised as Fever:oral temperature >=38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C& >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate(some interference with activity),severe(prevented daily routine activity).Vomiting:mild:1-2 times in 24 hours(h),moderate:>2 times in 24h,severe:required intravenous hydration.Diarrhea:mild: 2-3 loose stools in 24h,moderate:4-5 loose stools in 24h,severe:6 or more loose stools in 24h.G4 for all events:ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in CRF within 7 days after vaccination were also included.Exact 95%CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age Number of subjects analysed 16 16 4 12 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 deg C 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 33.3 (9.9 to 65.1)     Fever:38.0 to 38.4 deg C 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 16.7 (2.1 to 48.4)     Fever: >38.4 to 38.9 deg C 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 16.7 (2.1 to 48.4)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Fever: >40.0 deg C 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Fatigue: Any 50.0 (24.7 to 75.3) 68.8 (41.3 to 89.0) 100.0 (39.8 to 100.0) 50.0 (21.1 to 78.9)     Fatigue: Mild 37.5 (15.2 to 64.6) 31.3 (11.0 to 58.7) 25.0 (0.6 to 80.6) 16.7 (2.1 to 48.4)     Fatigue: Moderate 12.5 (1.6 to 38.3) 37.5 (15.2 to 64.6) 75.0 (19.4 to 99.4) 33.3 (9.9 to 65.1)     Fatigue: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Fatigue: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Headache: Any 25.0 (7.3 to 52.4) 31.3 (11.0 to 58.7) 75.0 (19.4 to 99.4) 33.3 (9.9 to 65.1)     Headache: Mild 18.8 (4.0 to 45.6) 31.3 (11.0 to 58.7) 50.0 (6.8 to 93.2) 25.0 (5.5 to 57.2)     Headache: Moderate 6.3 (0.2 to 30.2) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 8.3 (0.2 to 38.5)     Headache: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Headache: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Chills: Any 0 (0.0 to 20.6) 25.0 (7.3 to 52.4) 50.0 (6.8 to 93.2) 16.7 (2.1 to 48.4)     Chills: Mild 0 (0.0 to 20.6) 18.8 (4.0 to 45.6) 0 (0.0 to 60.2) 8.3 (0.2 to 38.5)     Chills: Moderate 0 (0.0 to 20.6) 6.3 (0.2 to 30.2) 50.0 (6.8 to 93.2) 8.3 (0.2 to 38.5)     Chills: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Chills: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Vomiting: Any 0 (0.0 to 20.6) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 8.3 (0.2 to 38.5)     Vomiting: Mild 0 (0.0 to 20.6) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 8.3 (0.2 to 38.5)     Vomiting: Moderate 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Vomiting: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Vomiting: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Any 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Mild 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Moderate 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened muscle pain: Any 12.5 (1.6 to 38.3) 25.0 (7.3 to 52.4) 100.0 (39.8 to 100.0) 0 (0.0 to 26.5)     New or worsened muscle pain: Mild 6.3 (0.2 to 30.2) 25.0 (7.3 to 52.4) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     New or worsened muscle pain: Moderate 6.3 (0.2 to 30.2) 0 (0.0 to 20.6) 75.0 (19.4 to 99.4) 0 (0.0 to 26.5)     New or worsened muscle pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened muscle pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened joint pain: Any 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 25.0 (0.6 to 80.6) 8.3 (0.2 to 38.5)     New or worsened joint pain: Mild 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 8.3 (0.2 to 38.5)     New or worsened joint pain: Moderate 0 (0.0 to 20.6) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     New or worsened joint pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened joint pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of age [5]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C.Fatigue, headache,chills, new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age Number of subjects analysed 16 16 4 12 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 deg C 12.5 (1.6 to 38.3) 18.8 (4.0 to 45.6) 100.0 (39.8 to 100.0) 0 (0.0 to 26.5)     Fever: 38.0 to 38.4 deg C 0 (0.0 to 20.6) 6.3 (0.2 to 30.2) 75.0 (19.4 to 99.4) 0 (0.0 to 26.5)     Fever: >38.4 to 38.9 deg C 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     Fever: >38.9 to 40.0 deg C 6.3 (0.2 to 30.2) 6.3 (0.2 to 30.2) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Fever: >40.0 deg C 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Fatigue: Any 68.8 (41.3 to 89.0) 62.5 (35.4 to 84.8) 100.0 (39.8 to 100.0) 75.0 (42.8 to 94.5)     Fatigue: Mild 43.8 (19.8 to 70.1) 25.0 (7.3 to 52.4) 25.0 (0.6 to 80.6) 58.3 (27.7 to 84.8)     Fatigue: Moderate 25.0 (7.3 to 52.4) 37.5 (15.2 to 64.6) 75.0 (19.4 to 99.4) 16.7 (2.1 to 48.4)     Fatigue: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Fatigue: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Headache: Any 50.0 (24.7 to 75.3) 56.3 (29.9 to 80.2) 75.0 (19.4 to 99.4) 33.3 (9.9 to 65.1)     Headache: Mild 25.0 (7.3 to 52.4) 25.0 (7.3 to 52.4) 25.0 (0.6 to 80.6) 25.0 (5.5 to 57.2)     Headache: Moderate 25.0 (7.3 to 52.4) 31.3 (11.0 to 58.7) 50.0 (6.8 to 93.2) 8.3 (0.2 to 38.5)     Headache: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Headache: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Chills: Any 31.3 (11.0 to 58.7) 43.8 (19.8 to 70.1) 75.0 (19.4 to 99.4) 33.3 (9.9 to 65.1)     Chills: Mild 25.0 (7.3 to 52.4) 25.0 (7.3 to 52.4) 75.0 (19.4 to 99.4) 33.3 (9.9 to 65.1)     Chills: Moderate 6.3 (0.2 to 30.2) 18.8 (4.0 to 45.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Chills: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Chills: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Vomiting: Any 0 (0.0 to 20.6) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 8.3 (0.2 to 38.5)     Vomiting: Mild 0 (0.0 to 20.6) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 8.3 (0.2 to 38.5)     Vomiting: Moderate 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Vomiting: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Vomiting: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Any 6.3 (0.2 to 30.2) 0 (0.0 to 20.6) 50.0 (6.8 to 93.2) 0 (0.0 to 26.5)     Diarrhea: Mild 6.3 (0.2 to 30.2) 0 (0.0 to 20.6) 50.0 (6.8 to 93.2) 0 (0.0 to 26.5)     Diarrhea: Moderate 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     Diarrhea: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened muscle pain: Any 0 (0.0 to 20.6) 18.8 (4.0 to 45.6) 50.0 (6.8 to 93.2) 8.3 (0.2 to 38.5)     New or worsened muscle pain: Mild 0 (0.0 to 20.6) 18.8 (4.0 to 45.6) 0 (0.0 to 60.2) 8.3 (0.2 to 38.5)     New or worsened muscle pain: Moderate 0 (0.0 to 20.6) 0 (0.0 to 20.6) 50.0 (6.8 to 93.2) 0 (0.0 to 26.5)     New or worsened muscle pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened muscle pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened joint pain: Any 0 (0.0 to 20.6) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     New or worsened joint pain: Mild 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened joint pain: Moderate 0 (0.0 to 20.6) 0 (0.0 to 20.6) 25.0 (0.6 to 80.6) 0 (0.0 to 26.5)     New or worsened joint pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)     New or worsened joint pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 20.6) 0 (0.0 to 60.2) 0 (0.0 to 26.5)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of age [6]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: 5 to <12 Years BNT162b2 10 mcg Number of subjects analysed 38 Units: Percentage of participants number (confidence interval 95%)     Fever:>=38.0 deg C 2.6 (0.1 to 13.8)     Fever:38.0 to 38.4 deg C 0 (0.0 to 9.3)     Fever: >38.4 to 38.9 deg C 0 (0.0 to 9.3)     Fever: >38.9 to 40.0 deg C 2.6 (0.1 to 13.8)     Fever: >40.0 deg C 0 (0.0 to 9.3)     Fatigue: Any 39.5 (24.0 to 56.6)     Fatigue: Mild 21.1 (9.6 to 37.3)     Fatigue: Moderate 15.8 (6.0 to 31.3)     Fatigue: Severe 2.6 (0.1 to 13.8)     Fatigue: Grade 4 0 (0.0 to 9.3)     Headache: Any 34.2 (19.6 to 51.4)     Headache: Mild 21.1 (9.6 to 37.3)     Headache: Moderate 10.5 (2.9 to 24.8)     Headache: Severe 2.6 (0.1 to 13.8)     Headache: Grade 4 0 (0.0 to 9.3)     Chills: Any 15.8 (6.0 to 31.3)     Chills: Mild 13.2 (4.4 to 28.1)     Chills: Moderate 2.6 (0.1 to 13.8)     Chills: Severe 0 (0.0 to 9.3)     Chills: Grade 4 0 (0.0 to 9.3)     Vomiting: Any 2.6 (0.1 to 13.8)     Vomiting: Mild 2.6 (0.1 to 13.8)     Vomiting: Moderate 0 (0.0 to 9.3)     Vomiting: Severe 0 (0.0 to 9.3)     Vomiting: Grade 4 0 (0.0 to 9.3)     Diarrhea: Any 0 (0.0 to 9.3)     Diarrhea: Mild 0 (0.0 to 9.3)     Diarrhea: Moderate 0 (0.0 to 9.3)     Diarrhea: Severe 0 (0.0 to 9.3)     Diarrhea: Grade 4 0 (0.0 to 9.3)     New or worsened muscle pain: Any 7.9 (1.7 to 21.4)     New or worsened muscle pain: Mild 2.6 (0.1 to 13.8)     New or worsened muscle pain: Moderate 5.3 (0.6 to 17.7)     New or worsened muscle pain: Severe 0 (0.0 to 9.3)     New or worsened muscle pain: Grade 4 0 (0.0 to 9.3)     New or worsened joint pain: Any 2.6 (0.1 to 13.8)     New or worsened joint pain: Mild 0 (0.0 to 9.3)     New or worsened joint pain: Moderate 2.6 (0.1 to 13.8)     New or worsened joint pain: Severe 0 (0.0 to 9.3)     New or worsened joint pain: Grade 4 0 (0.0 to 9.3)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of age [7]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalisation. Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Number of subjects analysed 16 32 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 0 (0.0 to 20.6) 28.1 (13.7 to 46.7)     Redness: Mild 0 (0.0 to 20.6) 25.0 (11.5 to 43.4)     Redness: Moderate 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     Redness: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Redness: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Swelling: Any 0 (0.0 to 20.6) 9.4 (2.0 to 25.0)     Swelling: Mild 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     Swelling: Moderate 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     Swelling: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Swelling: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Pain at the injection site: Any 31.3 (11.0 to 58.7) 62.5 (43.7 to 78.9)     Pain at the injection site: Mild 25.0 (7.3 to 52.4) 56.3 (37.7 to 73.6)     Pain at the injection site: Moderate 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Pain at the injection site: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Pain at the injection site: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of age [8]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalisation. Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Number of subjects analysed 16 32 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 0 (0.0 to 20.6) 15.6 (5.3 to 32.8)     Redness: Mild 0 (0.0 to 20.6) 15.6 (5.3 to 32.8)     Redness: Moderate 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Redness: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Redness: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Swelling: Any 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     Swelling: Mild 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Swelling: Moderate 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     Swelling: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Swelling: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Pain at the injection site: Any 37.5 (15.2 to 64.6) 53.1 (34.7 to 70.9)     Pain at the injection site: Mild 37.5 (15.2 to 64.6) 43.8 (26.4 to 62.3)     Pain at the injection site: Moderate 0 (0.0 to 20.6) 9.4 (2.0 to 25.0)     Pain at the injection site: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Pain at the injection site: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of age [9]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalisation. Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 3 mcg) Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 10 mcg) Number of subjects analysed 26 13 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 3.8 (0.1 to 19.6) 15.4 (1.9 to 45.4)     Redness: Mild 3.8 (0.1 to 19.6) 15.4 (1.9 to 45.4)     Redness: Moderate 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Redness: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Redness: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Swelling: Any 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Swelling: Mild 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Swelling: Moderate 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Swelling: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Swelling: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Pain at the injection site: Any 34.6 (17.2 to 55.7) 84.6 (54.6 to 98.1)     Pain at the injection site: Mild 34.6 (17.2 to 55.7) 38.5 (13.9 to 68.4)     Pain at the injection site: Moderate 0 (0.0 to 13.2) 38.5 (13.9 to 68.4)     Pain at the injection site: Severe 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Pain at the injection site: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of age [10]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Number of subjects analysed 16 32 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 deg C 0 (0.0 to 20.6) 18.8 (7.2 to 36.4)     Fever: 38.0 to 38.4 deg C 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     Fever: >38.4 to 38.9 deg C 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     Fever: >40.0 deg C 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Fatigue: Any 25.0 (7.3 to 52.4) 46.9 (29.1 to 65.3)     Fatigue: Mild 18.8 (4.0 to 45.6) 34.4 (18.6 to 53.2)     Fatigue: Moderate 6.3 (0.2 to 30.2) 12.5 (3.5 to 29.0)     Fatigue: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Fatigue: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Headache: Any 12.5 (1.6 to 38.3) 9.4 (2.0 to 25.0)     Headache: Mild 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Headache: Moderate 6.3 (0.2 to 30.2) 3.1 (0.1 to 16.2)     Headache: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Headache: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Chills: Any 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Chills: Mild 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Chills: Moderate 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Chills: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Chills: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Vomiting: Any 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     Vomiting: Mild 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     Vomiting: Moderate 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Vomiting: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Vomiting: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Diarrhea: Any 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Diarrhea: Mild 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Diarrhea: Moderate 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Diarrhea: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Diarrhea: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened muscle pain: Any 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     New or worsened muscle pain: Mild 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     New or worsened muscle pain: Moderate 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     New or worsened muscle pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened muscle pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened joint pain: Any 6.3 (0.2 to 30.2) 0 (0.0 to 10.9)     New or worsened joint pain: Mild 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened joint pain: Moderate 6.3 (0.2 to 30.2) 0 (0.0 to 10.9)     New or worsened joint pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened joint pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of age [11]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C.Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Number of subjects analysed 16 32 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 deg C 6.3 (0.2 to 30.2) 18.8 (7.2 to 36.4)     Fever: 38.0 to 38.4 deg C 0 (0.0 to 20.6) 9.4 (2.0 to 25.0)     Fever: >38.4 to 38.9 deg C 6.3 (0.2 to 30.2) 3.1 (0.1 to 16.2)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     Fever: >40.0 deg C 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Fatigue: Any 25.0 (7.3 to 52.4) 59.4 (40.6 to 76.3)     Fatigue: Mild 12.5 (1.6 to 38.3) 31.3 (16.1 to 50.0)     Fatigue: Moderate 12.5 (1.6 to 38.3) 28.1 (13.7 to 46.7)     Fatigue: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Fatigue: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Headache: Any 12.5 (1.6 to 38.3) 15.6 (5.3 to 32.8)     Headache: Mild 6.3 (0.2 to 30.2) 9.4 (2.0 to 25.0)     Headache: Moderate 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Headache: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Headache: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Chills: Any 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Chills: Mild 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     Chills: Moderate 6.3 (0.2 to 30.2) 0 (0.0 to 10.9)     Chills: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Chills: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Vomiting: Any 6.3 (0.2 to 30.2) 6.3 (0.8 to 20.8)     Vomiting: Mild 6.3 (0.2 to 30.2) 3.1 (0.1 to 16.2)     Vomiting: Moderate 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     Vomiting: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Vomiting: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Diarrhea: Any 6.3 (0.2 to 30.2) 12.5 (3.5 to 29.0)     Diarrhea: Mild 6.3 (0.2 to 30.2) 12.5 (3.5 to 29.0)     Diarrhea: Moderate 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Diarrhea: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     Diarrhea: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened muscle pain: Any 0 (0.0 to 20.6) 9.4 (2.0 to 25.0)     New or worsened muscle pain: Mild 0 (0.0 to 20.6) 6.3 (0.8 to 20.8)     New or worsened muscle pain: Moderate 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     New or worsened muscle pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened muscle pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened joint pain: Any 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     New or worsened joint pain: Mild 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened joint pain: Moderate 0 (0.0 to 20.6) 3.1 (0.1 to 16.2)     New or worsened joint pain: Severe 0 (0.0 to 20.6) 0 (0.0 to 10.9)     New or worsened joint pain: Grade 4 0 (0.0 to 20.6) 0 (0.0 to 10.9)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of age [12]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C.Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 3 mcg) Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 10 mcg) Number of subjects analysed 26 13 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 deg C 0 (0.0 to 13.2) 15.4 (1.9 to 45.4)     Fever: 38.0 to 38.4 deg C 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Fever: >38.4 to 38.9 deg C 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Fever: >40.0 deg C 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Fatigue: Any 30.8 (14.3 to 51.8) 53.8 (25.1 to 80.8)     Fatigue: Mild 19.2 (6.6 to 39.4) 23.1 (5.0 to 53.8)     Fatigue: Moderate 11.5 (2.4 to 30.2) 30.8 (9.1 to 61.4)     Fatigue: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Fatigue: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Headache: Any 3.8 (0.1 to 19.6) 23.1 (5.0 to 53.8)     Headache: Mild 3.8 (0.1 to 19.6) 15.4 (1.9 to 45.4)     Headache: Moderate 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Headache: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Headache: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Chills: Any 0 (0.0 to 13.2) 15.4 (1.9 to 45.4)     Chills: Mild 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Chills: Moderate 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     Chills: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Chills: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Vomiting: Any 0 (0.0 to 13.2) 23.1 (5.0 to 53.8)     Vomiting: Mild 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Vomiting: Moderate 0 (0.0 to 13.2) 23.1 (5.0 to 53.8)     Vomiting: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Vomiting: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Diarrhea: Any 3.8 (0.1 to 19.6) 7.7 (0.2 to 36.0)     Diarrhea: Mild 3.8 (0.1 to 19.6) 7.7 (0.2 to 36.0)     Diarrhea: Moderate 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Diarrhea: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     Diarrhea: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     New or worsened muscle pain: Any 0 (0.0 to 13.2) 15.4 (1.9 to 45.4)     New or worsened muscle pain: Mild 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     New or worsened muscle pain: Moderate 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     New or worsened muscle pain: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     New or worsened muscle pain: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)     New or worsened joint pain: Any 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     New or worsened joint pain: Mild 0 (0.0 to 13.2) 7.7 (0.2 to 36.0)     New or worsened joint pain: Moderate 0 (0.0 to 13.2) 0 (0.0 to 24.7)     New or worsened joint pain: Severe 0 (0.0 to 13.2) 0 (0.0 to 24.7)     New or worsened joint pain: Grade 4 0 (0.0 to 13.2) 0 (0.0 to 24.7)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of age [13]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)&Grade (G) 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]).Tenderness at injection site was graded as mild(hurts if gently touched),moderate(hurts if gently touched with crying),severe(causes limitation of limb movement)&G4 ER visit or hospitalisation.G4 were classified by investigator or medically qualified person.Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 16 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 18.8 (4.0 to 45.6)     Redness: Mild 18.8 (4.0 to 45.6)     Redness: Moderate 0 (0.0 to 20.6)     Redness: Severe 0 (0.0 to 20.6)     Redness: Grade 4 0 (0.0 to 20.6)     Swelling: Any 6.3 (0.2 to 30.2)     Swelling: Mild 6.3 (0.2 to 30.2)     Swelling: Moderate 0 (0.0 to 20.6)     Swelling: Severe 0 (0.0 to 20.6)     Swelling: Grade 4 0 (0.0 to 20.6)     Tenderness at the injection site: Any 0 (0.0 to 20.6)     Tenderness at the injection site: Mild 0 (0.0 to 20.6)     Tenderness at the injection site: Moderate 0 (0.0 to 20.6)     Tenderness at the injection site: Severe 0 (0.0 to 20.6)     Tenderness at the injection site: Grade 4 0 (0.0 to 20.6)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of age [14]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)&Grade (G) 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]).Tenderness at injection site was graded as mild(hurts if gently touched),moderate(hurts if gently touched with crying),severe(causes limitation of limb movement)&G4 ER visit or hospitalisation.G4 were classified by investigator or medically qualified person.Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 16 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 0 (0.0 to 20.6)     Redness: Mild 0 (0.0 to 20.6)     Redness: Moderate 0 (0.0 to 20.6)     Redness: Severe 0 (0.0 to 20.6)     Redness: Grade 4 0 (0.0 to 20.6)     Swelling: Any 0 (0.0 to 20.6)     Swelling: Mild 0 (0.0 to 20.6)     Swelling: Moderate 0 (0.0 to 20.6)     Swelling: Severe 0 (0.0 to 20.6)     Swelling: Grade 4 0 (0.0 to 20.6)     Tenderness at the injection site: Any 6.3 (0.2 to 30.2)     Tenderness at the injection site: Mild 6.3 (0.2 to 30.2)     Tenderness at the injection site: Moderate 0 (0.0 to 20.6)     Tenderness at the injection site: Severe 0 (0.0 to 20.6)     Tenderness at the injection site: Grade 4 0 (0.0 to 20.6)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of age [15]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)&G4(necrosis [redness and swelling] or exfoliative dermatitis [redness]).Tenderness at injection site was graded as mild(hurts if gently touched),moderate(hurts if gently touched with crying),severe(causes limitation of limb movement)&G4 ER visit or hospitalisation for severe tenderness at injection site).G4 were classified by investigator or medically qualified person.Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. 'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 15 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 13.3 (1.7 to 40.5)     Redness: Mild 13.3 (1.7 to 40.5)     Redness: Moderate 0 (0.0 to 21.8)     Redness: Severe 0 (0.0 to 21.8)     Redness: Grade 4 0 (0.0 to 21.8)     Swelling: Any 6.7 (0.2 to 31.9)     Swelling: Mild 6.7 (0.2 to 31.9)     Swelling: Moderate 0 (0.0 to 21.8)     Swelling: Severe 0 (0.0 to 21.8)     Swelling: Grade 4 0 (0.0 to 21.8)     Tenderness at the injection site: Any 26.7 (7.8 to 55.1)     Tenderness at the injection site: Mild 26.7 (7.8 to 55.1)     Tenderness at the injection site: Moderate 0 (0.0 to 21.8)     Tenderness at the injection site: Severe 0 (0.0 to 21.8)     Tenderness at the injection site: Grade 4 0 (0.0 to 21.8)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of age [16]
End point description	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 1.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C.Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake),severe (refusal to feed).Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity).Irritability: mild (easily consolable), moderate(requiring increased attention),severe(Inconsolable; crying cannot be comforted).G4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 16 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 6.3 (0.2 to 30.2)     Fever: 38.0 to 38.4 deg C 6.3 (0.2 to 30.2)     Fever: >38.4 to 38.9 deg C 0 (0.0 to 20.6)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 20.6)     Fever: >40.0 deg C 0 (0.0 to 20.6)     Decreased appetite: Any 6.3 (0.2 to 30.2)     Decreased appetite: Mild 0 (0.0 to 20.6)     Decreased appetite: Moderate 6.3 (0.2 to 30.2)     Decreased appetite: Severe 0 (0.0 to 20.6)     Decreased appetite: Grade 4 0 (0.0 to 20.6)     Drowsiness: Any 25.0 (7.3 to 52.4)     Drowsiness: Mild 18.8 (4.0 to 45.6)     Drowsiness: Moderate 6.3 (0.2 to 30.2)     Drowsiness: Severe 0 (0.0 to 20.6)     Drowsiness: Grade 4 0 (0.0 to 20.6)     Irritability: Any 43.8 (19.8 to 70.1)     Irritability: Mild 18.8 (4.0 to 45.6)     Irritability: Moderate 25.0 (7.3 to 52.4)     Irritability: Severe 0 (0.0 to 20.6)     Irritability: Grade 4 0 (0.0 to 20.6)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of age [17]
End point description	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 2.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C.Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake),severe (refusal to feed).Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity).Irritability: mild (easily consolable), moderate(requiring increased attention),severe(Inconsolable; crying cannot be comforted).G4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 16 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 12.5 (1.6 to 38.3)     Fever: 8.0 to 38.4 deg C 12.5 (1.6 to 38.3)     Fever: >38.4 to 38.9 deg C 0 (0.0 to 20.6)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 20.6)     Fever: >40.0 deg C 0 (0.0 to 20.6)     Decreased appetite: Any 12.5 (1.6 to 38.3)     Decreased appetite: Mild 12.5 (1.6 to 38.3)     Decreased appetite: Moderate 0 (0.0 to 20.6)     Decreased appetite: Severe 0 (0.0 to 20.6)     Decreased appetite: Grade 4 0 (0.0 to 20.6)     Drowsiness: Any 6.3 (0.2 to 30.2)     Drowsiness: Mild 6.3 (0.2 to 30.2)     Drowsiness: Moderate 0 (0.0 to 20.6)     Drowsiness: Severe 0 (0.0 to 20.6)     Drowsiness: Grade 4 0 (0.0 to 20.6)     Irritability: Any 31.3 (11.0 to 58.7)     Irritability: Mild 31.3 (11.0 to 58.7)     Irritability: Moderate 0 (0.0 to 20.6)     Irritability: Severe 0 (0.0 to 20.6)     Irritability: Grade 4 0 (0.0 to 20.6)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of age [18]
End point description	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 3. Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake),severe (refusal to feed).Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity).Irritability: mild (easily consolable), moderate(requiring increased attention),severe(Inconsolable; crying cannot be comforted).G4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population was used.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 15 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 6.7 (0.2 to 31.9)     Fever: 38.0 to 38.4 deg C 0 (0.0 to 21.8)     Fever: >38.4 to 38.9 deg C 0 (0.0 to 21.8)     Fever: >38.9 to 40.0 deg C 6.7 (0.2 to 31.9)     Fever: >40.0 deg C 0 (0.0 to 21.8)     Decreased appetite: Any 13.3 (1.7 to 40.5)     Decreased appetite: Mild 6.7 (0.2 to 31.9)     Decreased appetite: Moderate 6.7 (0.2 to 31.9)     Decreased appetite: Severe 0 (0.0 to 21.8)     Decreased appetite: Grade 4 0 (0.0 to 21.8)     Drowsiness: Any 6.7 (0.2 to 31.9)     Drowsiness: Mild 0 (0.0 to 21.8)     Drowsiness: Moderate 6.7 (0.2 to 31.9)     Drowsiness: Severe 0 (0.0 to 21.8)     Drowsiness: Grade 4 0 (0.0 to 21.8)     Irritability: Any 26.7 (7.8 to 55.1)     Irritability: Mild 13.3 (1.7 to 40.5)     Irritability: Moderate 13.3 (1.7 to 40.5)     Irritability: Severe 0 (0.0 to 21.8)     Irritability: Grade 4 0 (0.0 to 21.8)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of age [19]
End point description	An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 1 month after Dose 2
Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age Number of subjects analysed 16 16 4 12 Units: Percentage of participants     number (confidence interval 95%) 43.8 (19.8 to 70.1) 31.3 (11.0 to 58.7) 50.0 (6.8 to 93.2) 25.0 (5.5 to 57.2)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of age [20]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Exact 2-sided 95% CI based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 3 to 1 month after Dose 3
Notes [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: 5 to <12 Years BNT162b2 10 mcg Number of subjects analysed 38 Units: Percentage of participants     number (confidence interval 95%) 15.8 (6.0 to 31.3)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=5 to <12 Years of age [21]
End point description	A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic.Exact 2-sided 95% CI based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Phase 1:BNT162b2 (30/30 mcg): 5 to < 12 years of age Phase 1:BNT162b2 (30/10 mcg): 5 to < 12 years of age Number of subjects analysed 16 16 4 12 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 0) 0 (0 to 0) 0 (0 to 0) 0 (0 to 0)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of age [22]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic Exact 2-sided 95% CI based on the Clopper and Pearson method.Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 3 to 6 Months after Dose 3 (Approximately 6 months)
Notes [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: 5 to <12 Years BNT162b2 10 mcg Number of subjects analysed 38 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 0)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=2 to <5 Years of age [23]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.Exact 2-sided 95% CI based on the Clopper and Pearson method. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 3 to 1 month after Dose 3
Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 3 mcg) Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 10 mcg) Number of subjects analysed 27 13 Units: Percentage of participants     number (confidence interval 95%) 11.1 (2.4 to 29.2) 0 (0.0 to 24.7)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of age [24]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 1 month after Dose 2
Notes [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Number of subjects analysed 16 32 Units: Percentage of participants     number (confidence interval 95%) 25.0 (7.3 to 52.4) 37.5 (21.1 to 56.3)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=6 Months to <2 Years of age [25]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Exact 2-sided 95% CI based on the Clopper and Pearson method.Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From dose 3 to 1 month after dose 3
Notes [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 15 Units: Percentage of participants     number (confidence interval 95%) 6.7 (0.2 to 31.9)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=6 Months to <2 Years of age [26]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From dose 1 to 1 month after dose 2
Notes [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 16 Units: Percentage of participants     number (confidence interval 95%) 12.5 (1.6 to 38.3)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=2 to <5 Years of age [27]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From dose 3 to 6 months after dose 3 (Approximately 6 months)
Notes [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 3 mcg) Phase 1: BNT162b2: 2 to <5 Years of Age (Dose 3- 10 mcg) Number of subjects analysed 27 13 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 0) 0 (0 to 0)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of age [28]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Number of subjects analysed 16 32 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 0) 0 (0 to 0)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of age [29]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic.Exact 2-sided 95% CI based on the Clopper and Pearson method.Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From dose 3 to 6 months after dose 3 (Approximately 6 months)
Notes [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 15 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 0)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of age Top of page

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=6 Months to <2 Years of age Top of page
End point title	Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=6 Months to <2 Years of age [30]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic.Exact 2-sided 95% CI based on the Clopper and Pearson method.Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 16 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 0)
No statistical analyses for this end point

Primary: Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of age [31]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm),moderate (>5.0 to 10.0), severe >10.0 cm) and G4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and G4 ER visit or hospitalisation for severe pain at injection site). G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 515 260 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 15.5 (12.5 to 19.0) 6.2 (3.6 to 9.8)     Redness: Mild 11.8 (9.2 to 15.0) 5.4 (3.0 to 8.9)     Redness: Moderate 3.7 (2.2 to 5.7) 0.4 (0.0 to 2.1)     Redness: Severe 0 (0.0 to 0.7) 0.4 (0.0 to 2.1)     Redness: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Swelling: Any 10.9 (8.3 to 13.9) 4.6 (2.4 to 7.9)     Swelling: Mild 7.6 (5.4 to 10.2) 2.7 (1.1 to 5.5)     Swelling: Moderate 3.3 (1.9 to 5.2) 1.9 (0.6 to 4.4)     Swelling: Severe 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Swelling: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Pain at the injection site: Any 72.4 (68.3 to 76.2) 28.1 (22.7 to 34.0)     Pain at the injection site: Mild 57.7 (53.3 to 62.0) 23.5 (18.4 to 29.1)     Pain at the injection site: Moderate 14.8 (11.8 to 18.1) 4.6 (2.4 to 7.9)     Pain at the injection site: Severe 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Pain at the injection site: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of age [32]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm),moderate (>5.0 to 10.0), severe >10.0 cm) and G4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and G4 ER visit or hospitalisation for severe pain at injection site). G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 475 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 2.1 (1.0 to 3.8)     Redness: Mild 1.5 (0.6 to 3.0)     Redness: Moderate 0.6 (0.1 to 1.8)     Redness: Severe 0 (0.0 to 0.8)     Redness: Grade 4 0 (0.0 to 0.8)     Swelling: Any 4.4 (2.8 to 6.7)     Swelling: Mild 2.7 (1.5 to 4.6)     Swelling: Moderate 1.7 (0.7 to 3.3)     Swelling: Severe 0 (0.0 to 0.8)     Swelling: Grade 4 0 (0.0 to 0.8)     Pain at the injection site: Any 72.4 (68.2 to 76.4)     Pain at the injection site: Mild 43.8 (39.3 to 48.4)     Pain at the injection site: Moderate 28.2 (24.2 to 32.5)     Pain at the injection site: Severe 0.4 (0.1 to 1.5)     Pain at the injection site: Grade 4 0 (0.0 to 0.8)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of age [33]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. 'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 497 107 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 16.7 (13.5 to 20.3) 1.9 (0.2 to 6.6)     Redness: Mild 9.9 (7.4 to 12.8) 1.9 (0.2 to 6.6)     Redness: Moderate 6.8 (4.8 to 9.4) 0 (0.0 to 3.4)     Redness: Severe 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Redness: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Swelling: Any 11.5 (8.8 to 14.6) 4.7 (1.5 to 10.6)     Swelling: Mild 6.8 (4.8 to 9.4) 2.8 (0.6 to 8.0)     Swelling: Moderate 4.6 (3.0 to 6.9) 1.9 (0.2 to 6.6)     Swelling: Severe 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Swelling: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Pain at the injection site: Any 66.8 (62.5 to 70.9) 23.4 (15.7 to 32.5)     Pain at the injection site: Mild 48.3 (43.8 to 52.8) 19.6 (12.6 to 28.4)     Pain at the injection site: Moderate 18.5 (15.2 to 22.2) 3.7 (1.0 to 9.3)     Pain at the injection site: Severe 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Pain at the injection site: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of age [34]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm),moderate (>5.0 to 10.0), severe >10.0 cm) and G4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and G4 ER visit or hospitalisation for severe pain at injection site). G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 448 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 0.9 (0.2 to 2.3)     Redness: Mild 0.4 (0.1 to 1.6)     Redness: Moderate 0.2 (0.0 to 1.2)     Redness: Severe 0.2 (0.0 to 1.2)     Redness: Grade 4 0 (0.0 to 0.8)     Swelling: Any 1.8 (0.8 to 3.5)     Swelling: Mild 0.9 (0.2 to 2.3)     Swelling: Moderate 0.9 (0.2 to 2.3)     Swelling: Severe 0 (0.0 to 0.8)     Swelling: Grade 4 0 (0.0 to 0.8)     Pain at the injection site: Any 57.8 (53.1 to 62.4)     Pain at the injection site: Mild 36.6 (32.1 to 41.3)     Pain at the injection site: Moderate 20.8 (17.1 to 24.8)     Pain at the injection site: Severe 0.4 (0.1 to 1.6)     Pain at the injection site: Grade 4 0 (0.0 to 0.8)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of age [35]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. 'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 394 0 [36] Units: Percentage of participants number (confidence interval 95%)     Redness: Any 17.0 (13.4 to 21.1) ( to )     Redness: Mild 11.2 (8.2 to 14.7) ( to )     Redness: Moderate 5.8 (3.7 to 8.6) ( to )     Redness: Severe 0 (0.0 to 0.9) ( to )     Redness: Grade 4 0 (0.0 to 0.9) ( to )     Swelling: Any 12.7 (9.6 to 16.4) ( to )     Swelling: Mild 9.4 (6.7 to 12.7) ( to )     Swelling: Moderate 3.3 (1.8 to 5.6) ( to )     Swelling: Severe 0 (0.0 to 0.9) ( to )     Swelling: Grade 4 0 (0.0 to 0.9) ( to )     Pain at the injection site: Any 69.3 (64.5 to 73.8) ( to )     Pain at the injection site: Mild 48.0 (42.9 to 53.0) ( to )     Pain at the injection site: Moderate 20.8 (16.9 to 25.2) ( to )     Pain at the injection site: Severe 0.5 (0.1 to 1.8) ( to )     Pain at the injection site: Grade 4 0 (0.0 to 0.9) ( to )
Notes [36] - No participants received dose 3 from this cohort.
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of age [37]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm),moderate (>5.0 to 10.0), severe >10.0 cm) and G4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and G4 ER visit or hospitalisation for severe pain at injection site). G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all participants who received at least 1 dose of study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 405 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 3.5 (1.9 to 5.7)     Redness: Mild 3.0 (1.5 to 5.1)     Redness: Moderate 0.5 (0.1 to 1.8)     Redness: Severe 0 (0.0 to 0.9)     Redness: Grade 4 0 (0.0 to 0.9)     Swelling: Any 3.0 (1.5 to 5.1)     Swelling: Mild 2.0 (0.9 to 3.9)     Swelling: Moderate 1.0 (0.3 to 2.5)     Swelling: Severe 0 (0.0 to 0.9)     Swelling: Grade 4 0 (0.0 to 0.9)     Pain at the injection site: Any 63.5 (58.6 to 68.2)     Pain at the injection site: Mild 35.8 (31.1 to 40.7)     Pain at the injection site: Moderate 27.4 (23.1 to 32.0)     Pain at the injection site: Severe 0.2 (0.0 to 1.4)     Pain at the injection site: Grade 4 0 (0.0 to 0.9)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of age [38]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from upto Day 7 after Dose 1.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild:1-2 times in 24 hours,moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea:mild: 2-3 loose stools in 24 hours, moderate:4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours.Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95% CI based on Clopper and Pearson method.Safety population.'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 515 260 Units: Percentage of participants number (confidence interval 95%)     Fever: >= 38.0 1.4 (0.5 to 2.8) 3.1 (1.3 to 6.0)     Fever: 38.0 to 38.4 deg C 0.8 (0.2 to 2.0) 1.9 (0.6 to 4.4)     Fever: >38.4 to 38.9 deg C 0.6 (0.1 to 1.7) 1.2 (0.2 to 3.3)     Fever: >38.9 to 40.0 deg C 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Fever: >40.0 deg C 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Fatigue: Any 37.1 (32.9 to 41.4) 37.7 (31.8 to 43.9)     Fatigue: Mild 24.1 (20.4 to 28.0) 23.8 (18.8 to 29.5)     Fatigue: Moderate 13.0 (10.2 to 16.2) 13.1 (9.2 to 17.8)     Fatigue: Severe 0 (0.0 to 0.7) 0.8 (0.1 to 2.8)     Fatigue: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Headache: Any 25.4 (21.7 to 29.4) 25.8 (20.6 to 31.5)     Headache: Mild 18.3 (15.0 to 21.9) 19.2 (14.6 to 24.6)     Headache: Moderate 6.8 (4.8 to 9.3) 6.5 (3.9 to 10.3)     Headache: Severe 0.4 (0.0 to 1.4) 0 (0.0 to 1.4)     Headache: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Chills: Any 7.2 (5.1 to 9.8) 9.6 (6.3 to 13.9)     Chills: Mild 5.6 (3.8 to 8.0) 6.5 (3.9 to 10.3)     Chills: Moderate 1.4 (0.5 to 2.8) 3.1 (1.3 to 6.0)     Chills: Severe 0.2 (0.0 to 1.1) 0 (0.0 to 1.4)     Chills: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Vomiting: Any 1.7 (0.8 to 3.3) 2.3 (0.9 to 5.0)     Vomiting: Mild 1.6 (0.7 to 3.0) 1.9 (0.6 to 4.4)     Vomiting: Moderate 0.2 (0.0 to 1.1) 0.4 (0.0 to 2.1)     Vomiting: Severe 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Vomiting: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Diarrhea: Any 6.2 (4.3 to 8.7) 8.5 (5.4 to 12.5)     Diarrhea: Mild 6.0 (4.1 to 8.4) 8.1 (5.1 to 12.1)     Diarrhea: Moderate 0.2 (0.0 to 1.1) 0.4 (0.0 to 2.1)     Diarrhea: Severe 0 (0.0 to 0.7) 0 (0.0 to 1.4)     Diarrhea: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     New or worsened muscle pain: Any 11.7 (9.0 to 14.7) 10.0 (6.6 to 14.3)     New or worsened muscle pain: Mild 8.2 (5.9 to 10.9) 7.7 (4.8 to 11.6)     New or worsened muscle pain: Moderate 3.5 (2.1 to 5.5) 2.3 (0.9 to 5.0)     New or worsened muscle pain: Severe 0 (0.0 to 0.7) 0 (0.0 to 1.4)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)     New or worsened joint pain: Any 5.2 (3.5 to 7.5) 6.9 (4.2 to 10.7)     New or worsened joint pain: Mild 4.5 (2.9 to 6.6) 5.4 (3.0 to 8.9)     New or worsened joint pain: Moderate 0.8 (0.2 to 2.0) 1.5 (0.4 to 3.9)     New or worsened joint pain: Severe 0 (0.0 to 0.7) 0 (0.0 to 1.4)     New or worsened joint pain: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 1.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of age [39]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from upto Day 7 after Dose 1.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild:1-2 times in 24 hours,moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea:mild: 2-3 loose stools in 24 hours, moderate:4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours.Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95% CI based on Clopper and Pearson method.Safety population.'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 475 Units: Percentage of participants number (confidence interval 95%)     Fever:>=38.0 4.2 (2.6 to 6.4)     Fever: 8.0 to 38.4 deg C 2.3 (1.2 to 4.1)     Fever: >38.4 to 38.9 deg C 1.3 (0.5 to 2.7)     Fever: >38.9 to 40.0 deg C 0.6 (0.1 to 1.8)     Fever: >40.0 deg C 0 (0.0 to 0.8)     Fatigue: Any 42.3 (37.8 to 46.9)     Fatigue: Mild 26.3 (22.4 to 30.5)     Fatigue: Moderate 15.6 (12.4 to 19.2)     Fatigue: Severe 0.4 (0.1 to 1.5)     Fatigue: Grade 4 0 (0.0 to 0.8)     Headache: Any 33.3 (29.0 to 37.7)     Headache: Mild 22.9 (19.2 to 27.0)     Headache: Moderate 10.3 (7.7 to 13.4)     Headache: Severe 0 (0.0 to 0.8)     Headache: Grade 4 0 (0.0 to 0.8)     Chills: Any 11.4 (8.7 to 14.6)     Chills: Mild 8.6 (6.3 to 11.5)     Chills: Moderate 2.5 (1.3 to 4.4)     Chills: Severe 0.2 (0.0 to 1.2)     Chills: Grade 4 0 (0.0 to 0.8)     Vomiting: Any 2.9 (1.6 to 4.9)     Vomiting: Mild 2.7 (1.5 to 4.6)     Vomiting: Moderate 0.2 (0.0 to 1.2)     Vomiting: Severe 0 (0.0 to 0.8)     Vomiting: Grade 4 0 (0.0 to 0.8)     Diarrhea: Any 9.1 (6.6 to 12.0)     Diarrhea: Mild 6.9 (4.8 to 9.6)     Diarrhea: Moderate 2.1 (1.0 to 3.8)     Diarrhea: Severe 0 (0.0 to 0.8)     Diarrhea: Grade 4 0 (0.0 to 0.8)     New or worsened muscle pain: Any 26.3 (22.4 to 30.5)     New or worsened muscle pain: Mild 14.7 (11.7 to 18.2)     New or worsened muscle pain: Moderate 10.9 (8.3 to 14.1)     New or worsened muscle pain: Severe 0.6 (0.1 to 1.8)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.8)     New or worsened joint pain: Any 10.5 (7.9 to 13.6)     New or worsened joint pain: Mild 5.1 (3.3 to 7.4)     New or worsened joint pain: Moderate 5.5 (3.6 to 7.9)     New or worsened joint pain: Severe 0 (0.0 to 0.8)     New or worsened joint pain: Grade 4 0 (0.0 to 0.8)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2:Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2:Troponin Group: >=5 to <12 Years of age [40]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from upto Day 7 after Dose 2.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild:1-2 times in 24 hours,moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea:mild: 2-3 loose stools in 24 hours, moderate:4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours.Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95% CI based on Clopper and Pearson method.Safety population.'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 497 107 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 5.0 (3.3 to 7.3) 0 (0.0 to 3.4)     Fever:38.0 to 38.4 deg C 2.2 (1.1 to 3.9) 0 (0.0 to 3.4)     Fever: >38.4 to 38.9 deg C 1.8 (0.8 to 3.4) 0 (0.0 to 3.4)     Fever: >38.9 to 40.0 deg C 1.0 (0.3 to 2.3) 0 (0.0 to 3.4)     Fever: >40.0 deg C 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Fatigue: Any 38.2 (33.9 to 42.7) 29.0 (20.6 to 38.5)     Fatigue: Mild 22.5 (18.9 to 26.5) 15.9 (9.5 to 24.2)     Fatigue: Moderate 15.5 (12.4 to 19.0) 13.1 (7.3 to 21.0)     Fatigue: Severe 0.2 (0.0 to 1.1) 0 (0.0 to 3.4)     Fatigue: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Headache: Any 30.2 (26.2 to 34.4) 20.6 (13.4 to 29.5)     Headache: Mild 20.1 (16.7 to 23.9) 14.0 (8.1 to 22.1)     Headache: Moderate 9.9 (7.4 to 12.8) 6.5 (2.7 to 13.0)     Headache: Severe 0.2 (0.0 to 1.1) 0 (0.0 to 3.4)     Headache: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Chills: Any 9.1 (6.7 to 11.9) 7.5 (3.3 to 14.2)     Chills: Mild 5.8 (3.9 to 8.3) 6.5 (2.7 to 13.0)     Chills: Moderate 3.2 (1.9 to 5.2) 0.9 (0.0 to 5.1)     Chills: Severe 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Chills: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Vomiting: Any 2.0 (1.0 to 3.7) 3.7 (1.0 to 9.3)     Vomiting: Mild 1.8 (0.8 to 3.4) 2.8 (0.6 to 8.0)     Vomiting: Moderate 0.2 (0.0 to 1.1) 0.9 (0.0 to 5.1)     Vomiting: Severe 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Vomiting: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     Diarrhea: Any 7.4 (5.3 to 10.1) 5.6 (2.1 to 11.8)     Diarrhea: Mild 7.0 (5.0 to 9.7) 5.6 (2.1 to 11.8)     Diarrhea: Moderate 0.2 (0.0 to 1.1) 0 (0.0 to 3.4)     Diarrhea: Severe 0.2 (0.0 to 1.1) 0 (0.0 to 3.4)     Diarrhea: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     New or worsened muscle pain: Any 14.7 (11.7 to 18.1) 11.2 (5.9 to 18.8)     New or worsened muscle pain: Mild 9.3 (6.9 to 12.2) 9.3 (4.6 to 16.5)     New or worsened muscle pain: Moderate 5.4 (3.6 to 7.8) 1.9 (0.2 to 6.6)     New or worsened muscle pain: Severe 0 (0.0 to 0.7) 0 (0.0 to 3.4)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)     New or worsened joint pain: Any 6.4 (4.4 to 9.0) 6.5 (2.7 to 13.0)     New or worsened joint pain: Mild 4.2 (2.6 to 6.4) 6.5 (2.7 to 13.0)     New or worsened joint pain: Moderate 2.2 (1.1 to 3.9) 0 (0.0 to 3.4)     New or worsened joint pain: Severe 0 (0.0 to 0.7) 0 (0.0 to 3.4)     New or worsened joint pain: Grade 4 0 (0.0 to 0.7) 0 (0.0 to 3.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2:Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin group: >=12 to <16 Years of age [41]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from upto Day 7 after Dose 2.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild:1-2 times in 24 hours,moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea:mild: 2-3 loose stools in 24 hours, moderate:4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours.Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95% CI based on Clopper and Pearson method.Safety population.'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 448 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 3.3 (1.9 to 5.5)     Fever:38.0 to 38.4 deg C 1.6 (0.6 to 3.2)     Fever: >38.4 to 38.9 deg C 1.3 (0.5 to 2.9)     Fever: >38.9 to 40.0 deg C 0.4 (0.1 to 1.6)     Fever: >40.0 deg C 0 (0.0 to 0.8)     Fatigue: Any 36.4 (31.9 to 41.0)     Fatigue: Mild 21.0 (17.3 to 25.1)     Fatigue: Moderate 15.0 (11.8 to 18.6)     Fatigue: Severe 0.4 (0.1 to 1.6)     Fatigue: Grade 4 0 (0.0 to 0.8)     Headache: Any 33.3 (28.9 to 37.8)     Headache: Mild 19.4 (15.9 to 23.4)     Headache: Moderate 13.2 (10.2 to 16.7)     Headache: Severe 0.7 (0.1 to 1.9)     Headache: Grade 4 0 (0.0 to 0.8)     Chills: Any 11.2 (8.4 to 14.4)     Chills: Mild 7.4 (5.1 to 10.2)     Chills: Moderate 3.8 (2.2 to 6.0)     Chills: Severe 0 (0.0 to 0.8)     Chills: Grade 4 0 (0.0 to 0.8)     Vomiting: Any 2.2 (1.1 to 4.1)     Vomiting: Mild 2.0 (0.9 to 3.8)     Vomiting: Moderate 0.2 (0.0 to 1.2)     Vomiting: Severe 0 (0.0 to 0.8)     Vomiting: Grade 4 0 (0.0 to 0.8)     Diarrhea: Any 7.1 (4.9 to 9.9)     Diarrhea: Mild 5.1 (3.3 to 7.6)     Diarrhea: Moderate 1.8 (0.8 to 3.5)     Diarrhea: Severe 0.2 (0.0 to 1.2)     Diarrhea: Grade 4 0 (0.0 to 0.8)     New or worsened muscle pain: Any 19.6 (16.1 to 23.6)     New or worsened muscle pain: Mild 12.5 (9.6 to 15.9)     New or worsened muscle pain: Moderate 6.9 (4.7 to 9.7)     New or worsened muscle pain: Severe 0.2 (0.0 to 1.2)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.8)     New or worsened joint pain: Any 6.7 (4.6 to 9.4)     New or worsened joint pain: Mild 3.8 (2.2 to 6.0)     New or worsened joint pain: Moderate 2.7 (1.4 to 4.6)     New or worsened joint pain: Severe 0.2 (0.0 to 1.2)     New or worsened joint pain: Grade 4 0 (0.0 to 0.8)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of age [42]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from upto Day 7 after Dose 3.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild:1-2 times in 24 hours,moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea:mild: 2-3 loose stools in 24 hours, moderate:4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours.Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95% CI based on Clopper and Pearson method.Safety population.'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 394 0 [43] Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 4.6 (2.7 to 7.1) ( to )     Fever:38.0 to 38.4 deg C 2.5 (1.2 to 4.6) ( to )     Fever: >38.4 to 38.9 deg C 1.0 (0.3 to 2.6) ( to )     Fever: >38.9 to 40.0 deg C 1.0 (0.3 to 2.6) ( to )     Fever: >40.0 deg C 0 (0.0 to 0.9) ( to )     Fatigue: Any 38.8 (34.0 to 43.8) ( to )     Fatigue: Mild 26.4 (22.1 to 31.0) ( to )     Fatigue: Moderate 11.9 (8.9 to 15.5) ( to )     Fatigue: Severe 0.5 (0.1 to 1.8) ( to )     Fatigue: Grade 4 0 (0.0 to 0.9) ( to )     Headache: Any 23.6 (19.5 to 28.1) ( to )     Headache: Mild 16.2 (12.7 to 20.3) ( to )     Headache: Moderate 6.9 (4.6 to 9.8) ( to )     Headache: Severe 0.5 (0.1 to 1.8) ( to )     Headache: Grade 4 0 (0.0 to 0.9) ( to )     Chills: Any 8.9 (6.3 to 12.1) ( to )     Chills: Mild 5.8 (3.7 to 8.6) ( to )     Chills: Moderate 2.8 (1.4 to 4.9) ( to )     Chills: Severe 0.3 (0.0 to 1.4) ( to )     Chills: Grade 4 0 (0.0 to 0.9) ( to )     Vomiting: Any 1.8 (0.7 to 3.6) ( to )     Vomiting: Mild 1.5 (0.6 to 3.3) ( to )     Vomiting: Moderate 0.3 (0.0 to 1.4) ( to )     Vomiting: Severe 0 (0.0 to 0.9) ( to )     Vomiting: Grade 4 0 (0.0 to 0.9) ( to )     Diarrhea: Any 4.8 (2.9 to 7.4) ( to )     Diarrhea: Mild 4.6 (2.7 to 7.1) ( to )     Diarrhea: Moderate 0.3 (0.0 to 1.4) ( to )     Diarrhea: Severe 0 (0.0 to 0.9) ( to )     Diarrhea: Grade 4 0 (0.0 to 0.9) ( to )     New or worsened muscle pain: Any 18.5 (14.8 to 22.7) ( to )     New or worsened muscle pain: Mild 10.2 (7.4 to 13.6) ( to )     New or worsened muscle pain: Moderate 8.4 (5.8 to 11.6) ( to )     New or worsened muscle pain: Severe 0 (0.0 to 0.9) ( to )     New or worsened muscle pain: Grade 4 0 (0.0 to 0.9) ( to )     New or worsened joint pain: Any 5.8 (3.7 to 8.6) ( to )     New or worsened joint pain: Mild 4.1 (2.3 to 6.5) ( to )     New or worsened joint pain: Moderate 1.8 (0.7 to 3.6) ( to )     New or worsened joint pain: Severe 0 (0.0 to 0.9) ( to )     New or worsened joint pain: Grade 4 0 (0.0 to 0.9) ( to )
Notes [43] - No participants received dose 3 from this cohort.
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of age [44]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from upto Day 7 after Dose 3.Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild:1-2 times in 24 hours,moderate: >2 times in 24 hours,severe: required intravenous hydration.Diarrhea:mild: 2-3 loose stools in 24 hours, moderate:4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours.Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95% CI based on Clopper and Pearson method.Safety population.'N'= participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 405 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 3.5 (1.9 to 5.7)     Fever: 8.0 to 38.4 deg C 1.7 (0.7 to 3.5)     Fever: >38.4 to 38.9 deg C 1.2 (0.4 to 2.9)     Fever: >38.9 to 40.0 deg C 0.5 (0.1 to 1.8)     Fever: >40.0 deg C 0 (0.0 to 0.9)     Fatigue: Any 36.8 (32.1 to 41.7)     Fatigue: Mild 21.7 (17.8 to 26.1)     Fatigue: Moderate 14.8 (11.5 to 18.7)     Fatigue: Severe 0.2 (0.0 to 1.4)     Fatigue: Grade 4 0 (0.0 to 0.9)     Headache: Any 35.3 (30.7 to 40.2)     Headache: Mild 23.0 (19.0 to 27.4)     Headache: Moderate 11.6 (8.7 to 15.1)     Headache: Severe 0.7 (0.2 to 2.1)     Headache: Grade 4 0 (0.0 to 0.9)     Chills: Any 12.8 (9.7 to 16.5)     Chills: Mild 8.4 (5.9 to 11.5)     Chills: Moderate 4.4 (2.7 to 6.9)     Chills: Severe 0 (0.0 to 0.9)     Chills: Grade 4 0 (0.0 to 0.9)     Vomiting: Any 2.7 (1.4 to 4.8)     Vomiting: Mild 2.2 (1.0 to 4.2)     Vomiting: Moderate 0.5 (0.1 to 1.8)     Vomiting: Severe 0 (0.0 to 0.9)     Vomiting: Grade 4 0 (0.0 to 0.9)     Diarrhea: Any 4.4 (2.7 to 6.9)     Diarrhea: Mild 4.0 (2.3 to 6.3)     Diarrhea: Moderate 0.5 (0.1 to 1.8)     Diarrhea: Severe 0 (0.0 to 0.9)     Diarrhea: Grade 4 0 (0.0 to 0.9)     New or worsened muscle pain: Any 18.8 (15.1 to 22.9)     New or worsened muscle pain: Mild 10.6 (7.8 to 14.0)     New or worsened muscle pain: Moderate 8.1 (5.7 to 11.3)     New or worsened muscle pain: Severe 0 (0.0 to 0.9)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.9)     New or worsened joint pain: Any 6.4 (4.2 to 9.3)     New or worsened joint pain: Mild 4.0 (2.3 to 6.3)     New or worsened joint pain: Moderate 2.5 (1.2 to 4.5)     New or worsened joint pain: Severe 0 (0.0 to 0.9)     New or worsened joint pain: Grade 4 0 (0.0 to 0.9)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=5 to <12 Years of age [45]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 1 month after Dose 2
Notes [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 518 260 Units: Percentage of participants     number (confidence interval 95%) 7.1 (5.1 to 9.7) 8.1 (5.1 to 12.1)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=12 to <16 Years of age [46]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 1 month after Dose 2
Notes [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 487 Units: Percentage of participants     number (confidence interval 95%) 5.3 (3.5 to 7.7)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group: >=5 to <12 Years of age [47]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 3 to 1 month after Dose 3
Notes [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 418 202 Units: Percentage of participants     number (confidence interval 95%) 11.5 (8.6 to 14.9) 15.3 (10.7 to 21.1)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group:>=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group:>=12 to <16 Years of age [48]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 3 to 1 month after Dose 3
Notes [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 433 Units: Percentage of participants     number (confidence interval 95%) 1.4 (0.5 to 3.0)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group:>=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : Troponin Group: >=5 to <12 Years of age [49]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 518 260 Units: Percentage of participants     number (confidence interval 95%) 0.2 (0.0 to 1.1) 0 (0.0 to 1.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Troponin Group: >=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Troponin Group: >=12 to <16 Years of age [50]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 487 Units: Percentage of participants     number (confidence interval 95%) 0.4 (0.0 to 1.5)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Troponin Group: >=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of age [51]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)& G4 (necrosis[redness and swelling]or exfoliative dermatitis[redness]).Pain at injection site was graded as mild(did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity)&G4 ER visit or hospitalisation for severe pain at injection site).G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included.Two-sided 95% CI was based on Clopper and Pearson method.Safety population=all participants who received at least 1 dose of study intervention.‘N’ signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 3096 1532 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (3096,1532) 14.0 (12.8 to 15.3) 5.9 (4.8 to 7.2)     Redness: Mild (3096,1532) 9.3 (8.3 to 10.3) 5.1 (4.0 to 6.3)     Redness: Moderate (3096,1532) 4.7 (4.0 to 5.5) 0.7 (0.4 to 1.3)     Redness: Severe (3096,1532) 0.0 (0.0 to 0.2) 0.1 (0.0 to 0.5)     Redness: Grade 4 (3096,1532) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Swelling: Any (3096,1532) 10.3 (9.3 to 11.5) 3.0 (2.2 to 4.0)     Swelling: Mild (3096,1532) 5.7 (4.9 to 6.6) 1.8 (1.2 to 2.6)     Swelling: Moderate (3096,1532) 4.6 (3.9 to 5.4) 1.2 (0.7 to 1.9)     Swelling: Severe (3096,1532) 0.0 (0.0 to 0.2) 0 (0.0 to 0.2)     Swelling: Grade 4 (3096,1532) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Pain at the injection site: Any (3096,1531) 72.9 (71.3 to 74.5) 31.5 (29.2 to 33.9)     Pain at the injection site: Mild (3096,1531) 58.5 (56.7 to 60.2) 28.3 (26.1 to 30.7)     Pain at the injection site: Moderate (3096,1531) 14.3 (13.1 to 15.6) 3.1 (2.3 to 4.1)     Pain at the injection site: Severe (3096,1531) 0.2 (0.1 to 0.4) 0 (0.0 to 0.2)     Pain at the injection site: Grade 4 (3096,1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : Troponin Group:>=12 to <16 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : Troponin Group:>=12 to <16 Years of age [52]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 3 to 6 months after Dose 3
Notes [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (30 mcg):12 to <16 years Number of subjects analysed 433 Units: Percentage of participants     number (confidence interval 95%) 1.4 (0.5 to 3.0)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : Troponin Group:>=12 to <16 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: Troponin Group: >=5 to <12 Years of age [53]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 3 to 6 months after Dose 3 (Approximately 6 months)
Notes [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3:Troponin group:BNT162b2 (10 mcg):5 to <12 years Phase 2/3:Troponin group:Placebo:5 to <12 years Number of subjects analysed 418 202 Units: Percentage of participants     number (confidence interval 95%) 0.5 (0.1 to 1.7) 0 (0.0 to 1.8)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: Troponin Group: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of age [54]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)& G4 (necrosis[redness and swelling]or exfoliative dermatitis[redness]).Pain at injection site was graded as mild(did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity)&G4 ER visit or hospitalisation for severe pain at injection site).G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included.Two-sided 95% CI was based on Clopper and Pearson method.Safety population=all participants who received at least 1 dose of study intervention.‘N’ signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 3064 1522 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (3064, 1522) 18.8 (17.4 to 20.2) 5.2 (4.1 to 6.4)     Redness: Mild (3064, 1522) 10.3 (9.2 to 11.4) 3.7 (2.8 to 4.8)     Redness: Moderate (3064, 1522) 8.4 (7.4 to 9.4) 1.3 (0.8 to 2.0)     Redness: Severe (3064, 1522) 0.1 (0.0 to 0.3) 0.1 (0.0 to 0.5)     Redness: Grade 4 (3064, 1522) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Swelling: Any (3064, 1522) 14.7 (13.5 to 16.0) 2.7 (1.9 to 3.6)     Swelling: Mild (3064, 1522) 8.1 (7.1 to 9.1) 2.0 (1.3 to 2.8)     Swelling: Moderate (3064, 1522) 6.6 (5.8 to 7.6) 0.7 (0.4 to 1.3)     Swelling: Severe (3064, 1522) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Swelling: Grade 4 (3064, 1522) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Pain at the injection site: Any (3064, 1521) 71.2 (69.5 to 72.8) 28.5 (26.3 to 30.9)     Pain at the injection site: Mild (3064, 1521) 53.6 (51.8 to 55.4) 25.6 (23.4 to 27.8)     Pain at the injection site: Moderate (3064, 1521) 17.4 (16.1 to 18.8) 2.9 (2.1 to 3.9)     Pain at the injection site: Severe (3064, 1521) 0.2 (0.1 to 0.4) 0.1 (0.0 to 0.4)     Pain at the injection site: Grade 4 (3064, 1521) 0 (0.0 to 0.1) 0 (0.0 to 0.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of age [55]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)& G4 (necrosis[redness and swelling]or exfoliative dermatitis[redness]).Pain at injection site was graded as mild(did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity)&G4 ER visit or hospitalisation for severe pain at injection site).G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included.Two-sided 95% CI was based on Clopper and Pearson method.Safety population=all participants who received at least 1 dose of study intervention.‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Number of subjects analysed 2265 Units: Percentage of participants number (confidence interval 95%)     Redness: Any 15.6 (14.2 to 17.2)     Redness: Mild 9.4 (8.3 to 10.7)     Redness: Moderate 6.1 (5.1 to 7.2)     Redness: Severe 0.1 (0.0 to 0.3)     Redness: Grade 4 0 (0.0 to 0.2)     Swelling: Any 12.6 (11.3 to 14.1)     Swelling: Mild 6.5 (5.6 to 7.6)     Swelling: Moderate 6.1 (5.1 to 7.2)     Swelling: Severe 0 (0.0 to 0.2)     Swelling: Grade 4 0 (0.0 to 0.2)     Pain at the injection site: Any 69.2 (67.3 to 71.1)     Pain at the injection site: Mild 48.0 (46.0 to 50.1)     Pain at the injection site: Moderate 20.9 (19.3 to 22.7)     Pain at the injection site: Severe 0.3 (0.1 to 0.6)     Pain at the injection site: Grade 4 0 (0.0 to 0.2)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of age [56]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments upto Day 7 after Dose 1. Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain &joint pain: mild(did not interfere with activity),moderate(some interference with activity),severe(prevented daily routine activity).Vomiting:mild:1-2 times in 24 h,moderate:>2 times in 24 h, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24h,moderate:4-5 loose stools in 24h,severe:6 or more loose stools in 24h.G4 for all events: ER visit/hospitalisation & were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95%CI based on Clopper and Pearson method. Safety population was used. ‘N= participants evaluable for this endpoint & ‘n'= participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 3096 1532 Units: Percentage of participants number (confidence interval 95%)     Fever:>=38.0 (n=3096, 1532) 2.1 (1.6 to 2.6) 1.4 (0.9 to 2.1)     Fever: 38.0 to 38.4 deg C (n=3096, 1532) 1.2 (0.8 to 1.6) 0.7 (0.3 to 1.2)     Fever: >38.4 to 38.9 deg C (n=3096, 1532) 0.7 (0.4 to 1.1) 0.6 (0.3 to 1.1)     Fever: >38.9 to 40.0 deg C (n=3096, 1532) 0.1 (0.0 to 0.3) 0.1 (0.0 to 0.5)     Fever: >40.0 deg C (n=3096, 1532) 0.0 (0.0 to 0.2) 0 (0.0 to 0.2)     Fatigue: Any (n=3096, 1531) 34.5 (32.8 to 36.2) 32.4 (30.1 to 34.8)     Fatigue: Mild (n=3096, 1531) 22.7 (21.2 to 24.2) 21.1 (19.1 to 23.2)     Fatigue: Moderate (n=3096, 1531) 11.6 (10.5 to 12.8) 11.2 (9.6 to 12.9)     Fatigue: Severe (n=3096, 1531) 0.2 (0.1 to 0.4) 0.1 (0.0 to 0.5)     Fatigue: Grade 4 (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Headache: Any (n=3096, 1531) 22.7 (21.2 to 24.2) 24.3 (22.2 to 26.5)     Headache: Mild (n=3096, 1531) 17.1 (15.8 to 18.5) 18.0 (16.1 to 20.0)     Headache: Moderate (n=3096, 1531) 5.5 (4.7 to 6.4) 5.9 (4.8 to 7.2)     Headache: Severe (n=3096, 1531) 0.1 (0.0 to 0.3) 0.4 (0.1 to 0.9)     Headache: Grade 4 (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Chills: Any (n=3096, 1531) 5.6 (4.8 to 6.5) 5.5 (4.4 to 6.7)     Chills: Mild (n=3096, 1531) 4.5 (3.8 to 5.2) 4.5 (3.5 to 5.7)     Chills: Moderate (n=3096, 1531) 1.2 (0.8 to 1.6) 1.0 (0.5 to 1.6)     Chills: Severe (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Chills: Grade 4 (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Vomiting: Any (n=3096, 1531) 2.0 (1.6 to 2.6) 2.0 (1.3 to 2.8)     Vomiting: Mild (n=3096, 1531) 1.7 (1.3 to 2.2) 1.8 (1.2 to 2.6)     Vomiting: Moderate (n=3096, 1531) 0.4 (0.2 to 0.6) 0.1 (0.0 to 0.5)     Vomiting: Severe (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Vomiting: Grade 4 (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Diarrhea: Any (n=3096, 1531) 6.4 (5.6 to 7.3) 4.9 (3.9 to 6.1)     Diarrhea: Mild (n=3096, 1531) 5.9 (5.1 to 6.8) 4.7 (3.7 to 5.9)     Diarrhea: Moderate (n=3096, 1531) 0.5 (0.2 to 0.8) 0.2 (0.0 to 0.6)     Diarrhea: Severe (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Diarrhea: Grade 4 (n=3096, 1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     New or worsened muscle pain: Any(n=3096,1531) 9.3 (8.3 to 10.4) 8.2 (6.9 to 9.7)     New or worsened muscle pain: Mild(n=3096,1531) 6.7 (5.8 to 7.6) 6.3 (5.1 to 7.6)     New or worsened muscle pain: Moderate(n=3096,1531) 2.6 (2.1 to 3.3) 2.0 (1.3 to 2.8)     New or worsened muscle pain: Severe(n=3096,1531) 0.0 (0.0 to 0.2) 0 (0.0 to 0.2)     New or worsened muscle pain:G4 (n=3096,1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     New or worsened joint pain:Any (n=3096,1531) 3.4 (2.8 to 4.1) 4.6 (3.6 to 5.7)     New or worsened joint pain:Mild (n=3096,1531) 2.3 (1.8 to 2.9) 3.7 (2.8 to 4.7)     New or worsened joint pain:Moderate(n=3096,1531) 1.1 (0.8 to 1.6) 0.9 (0.5 to 1.5)     New or worsened joint pain:Severe (n=3096,1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     New or worsened joint pain: G4 (n=3096,1531) 0 (0.0 to 0.1) 0 (0.0 to 0.2)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of age [57]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments upto Day 7 after Dose 2. Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain &joint pain: mild(did not interfere with activity),moderate(some interference with activity),severe(prevented daily routine activity).Vomiting:mild:1-2 times in 24 h,moderate:>2 times in 24 h, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24h,moderate:4-5 loose stools in 24h,severe:6 or more loose stools in 24h.G4 for all events: ER visit/hospitalisation & were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95%CI based on Clopper and Pearson method. Safety population was used. ‘N= participants evaluable for this endpoint & ‘n'= participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 3064 1522 Units: Percentage of participants number (confidence interval 95%)     Fever: Any (n=3064, 1522) 6.3 (5.5 to 7.2) 1.4 (0.9 to 2.1)     Fever: >=38.0 to 38.4 deg C (n=3064, 1522) 3.3 (2.7 to 4.0) 0.9 (0.5 to 1.5)     Fever: >38.4 to 38.9 deg C (n=3064, 1522) 2.3 (1.8 to 2.9) 0.3 (0.1 to 0.8)     Fever: >38.9 to 40.0 deg C (n=3064,1522) 0.7 (0.4 to 1.0) 0.2 (0.0 to 0.6)     Fever: >40.0 deg C (n=3064, 1522) 0.0 (0.0 to 0.2) 0 (0.0 to 0.2)     Fatigue: Any (n=3064, 1521) 39.2 (37.4 to 40.9) 25.2 (23.0 to 27.4)     Fatigue: Mild (n=3064, 1521) 21.7 (20.3 to 23.2) 15.1 (13.4 to 17.0)     Fatigue: Moderate (n=3064, 1521) 16.6 (15.3 to 17.9) 9.8 (8.3 to 11.4)     Fatigue: Severe (n=3064, 1521) 0.9 (0.6 to 1.3) 0.3 (0.1 to 0.7)     Fatigue: Grade 4 (n=3064, 1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Headache: Any (n=3064, 1521) 28.4 (26.8 to 30.0) 18.7 (16.7 to 20.7)     Headache: Mild (n=3064, 1521) 18.8 (17.4 to 20.2) 13.2 (11.6 to 15.0)     Headache: Moderate (n=3064, 1521) 9.3 (8.3 to 10.4) 5.4 (4.3 to 6.6)     Headache: Severe (n=3064, 1521) 0.3 (0.1 to 0.5) 0.1 (0.0 to 0.4)     Headache: Grade 4 (n=3064, 1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Chills: Any (n=3064, 1521) 9.8 (8.8 to 10.9) 4.3 (3.4 to 5.5)     Chills: Mild (n=3064, 1521) 6.7 (5.8 to 7.6) 3.4 (2.6 to 4.5)     Chills: Moderate (n=3064, 1521) 3.1 (2.5 to 3.7) 0.9 (0.5 to 1.5)     Chills: Severe (n=3064, 1521) 0.1 (0.0 to 0.2) 0.1 (0.0 to 0.4)     Chills: Grade 4 (n=3064, 1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Vomiting: Any (n=3064, 1521) 2.0 (1.6 to 2.6) 1.8 (1.2 to 2.6)     Vomiting: Mild (n=3064, 1521) 1.8 (1.4 to 2.4) 1.4 (0.9 to 2.2)     Vomiting: Moderate (n=3064, 1521) 0.2 (0.1 to 0.4) 0.3 (0.1 to 0.8)     Vomiting: Severe (n=3064, 1521) 0.0 (0.0 to 0.2) 0 (0.0 to 0.2)     Vomiting: Grade 4 (n=3064, 1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     Diarrhea: Any (n=3064, 1521) 5.4 (4.6 to 6.3) 5.0 (4.0 to 6.2)     Diarrhea: Mild (n=3064, 1521) 4.9 (4.1 to 5.7) 4.6 (3.6 to 5.8)     Diarrhea: Moderate (n=3064, 1521) 0.5 (0.3 to 0.8) 0.4 (0.1 to 0.9)     Diarrhea: Severe (n=3064, 1521) 0.1 (0.0 to 0.2) 0 (0.0 to 0.2)     Diarrhea: Grade 4 (n=3064, 1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     New or worsened muscle pain:Any (n=3064,1521) 12.0 (10.9 to 13.2) 6.8 (5.6 to 8.2)     New or worsened muscle pain:Mild (n=3064,1521) 8.0 (7.1 to 9.0) 4.5 (3.5 to 5.6)     New or worsened muscle pain: Moderate(n=3064,1521) 4.0 (3.3 to 4.7) 2.4 (1.7 to 3.3)     New or worsened muscle pain: Severe(n=3064,1521) 0.0 (0.0 to 0.2) 0 (0.0 to 0.2)     New or worsened muscle pain:G4 (n=3064,1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     New or worsened joint pain:Any (n=3064,1521) 5.2 (4.4 to 6.0) 3.7 (2.9 to 4.8)     New or worsened joint pain:Mild (n=3064,1521) 3.4 (2.8 to 4.1) 2.8 (2.0 to 3.7)     New or worsened joint pain: Moderate(n=3064,1521) 1.8 (1.4 to 2.4) 1.0 (0.6 to 1.6)     New or worsened joint pain: Severe (n=3064,1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)     New or worsened joint pain:G4 (n=3064,1521) 0 (0.0 to 0.1) 0 (0.0 to 0.2)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=5 to <12 Years of age [58]
End point description	Systemic events were recorded in an e-diary and at unscheduled clinical assessments upto Day 7 after Dose 3. Fever: oral temperature >= 38.0 deg C;categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C,>38.9 to 40.0 deg C and >40.0 deg C.Fatigue,headache,chills,new or worsened muscle pain &joint pain: mild(did not interfere with activity),moderate(some interference with activity),severe(prevented daily routine activity).Vomiting:mild:1-2 times in 24 h,moderate:>2 times in 24 h, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24h,moderate:4-5 loose stools in 24h,severe:6 or more loose stools in 24h.G4 for all events: ER visit/hospitalisation & were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95%CI based on Clopper and Pearson method. Safety population was used. ‘N= participants evaluable for this endpoint & ‘n'= participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Number of subjects analysed 2265 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 6.8 (5.8 to 7.9)     Fever:38.0 to 38.4 deg C 4.1 (3.3 to 5.0)     Fever: >38.4 to 38.9 deg C 1.8 (1.3 to 2.4)     Fever: >38.9 to 40.0 deg C 0.9 (0.5 to 1.4)     Fever: >40.0 deg C 0.0 (0.0 to 0.2)     Fatigue: Any 39.6 (37.6 to 41.7)     Fatigue: Mild 21.0 (19.4 to 22.8)     Fatigue: Moderate 17.3 (15.8 to 18.9)     Fatigue: Severe 1.3 (0.9 to 1.8)     Fatigue: Grade 4 0 (0.0 to 0.2)     Headache: Any 26.9 (25.1 to 28.8)     Headache: Mild 16.2 (14.7 to 17.8)     Headache: Moderate 10.3 (9.1 to 11.7)     Headache: Severe 0.4 (0.2 to 0.8)     Headache: Grade 4 0 (0.0 to 0.2)     Chills: Any 10.2 (9.0 to 11.5)     Chills: Mild 6.2 (5.2 to 7.3)     Chills: Moderate 3.9 (3.1 to 4.8)     Chills: Severe 0.1 (0.0 to 0.4)     Chills: Grade 4 0 (0.0 to 0.2)     Vomiting: Any 2.7 (2.1 to 3.4)     Vomiting: Mild 2.2 (1.6 to 2.9)     Vomiting: Moderate 0.4 (0.2 to 0.8)     Vomiting: Severe 0.0 (0.0 to 0.2)     Vomiting: Grade 4 0 (0.0 to 0.2)     Diarrhea: Any 4.6 (3.8 to 5.5)     Diarrhea: Mild 4.3 (3.5 to 5.2)     Diarrhea: Moderate 0.3 (0.1 to 0.6)     Diarrhea: Severe 0.0 (0.0 to 0.2)     Diarrhea: Grade 4 0 (0.0 to 0.2)     New or worsened muscle pain: Any 15.5 (14.0 to 17.0)     New or worsened muscle pain: Mild 8.8 (7.7 to 10.0)     New or worsened muscle pain: Moderate 6.5 (5.6 to 7.6)     New or worsened muscle pain: Severe 0.1 (0.0 to 0.4)     New or worsened muscle pain: Grade 4 0 (0.0 to 0.2)     New or worsened joint pain: Any 5.7 (4.8 to 6.7)     New or worsened joint pain: Mild 3.5 (2.8 to 4.3)     New or worsened joint pain: Moderate 2.2 (1.6 to 2.9)     New or worsened joint pain: Severe 0.0 (0.0 to 0.2)     New or worsened joint pain: Grade 4 0 (0.0 to 0.2)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of age [59]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)& G4 (necrosis[redness and swelling]or exfoliative dermatitis[redness]).Pain at injection site was graded as mild(did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity)&G4 ER visit or hospitalisation.G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included.Two-sided 95% CI was based on Clopper and Pearson method.Safety population=all participants who received at least 1 dose of study intervention.‘N’ signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 2327 1164 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (2327, 1164) 9.0 (7.9 to 10.3) 8.4 (6.9 to 10.2)     Redness: Mild (2327, 1164) 7.7 (6.7 to 8.9) 7.5 (6.0 to 9.1)     Redness: Moderate (2327, 1164) 1.2 (0.8 to 1.8) 0.9 (0.4 to 1.6)     Redness: Severe (2327, 1164) 0.0 (0.0 to 0.2) 0.1 (0.0 to 0.5)     Redness: Grade 4 (2327, 1164) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Swelling: Any (2327, 1164) 3.9 (3.2 to 4.8) 3.1 (2.2 to 4.3)     Swelling: Mild (2327, 1164) 3.4 (2.7 to 4.3) 2.5 (1.7 to 3.6)     Swelling: Moderate (2327, 1164) 0.5 (0.2 to 0.8) 0.6 (0.2 to 1.2)     Swelling: Severe (2327, 1164) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Swelling: Grade 4 (2327, 1164) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Pain at the injection site: Any (2305, 1159) 30.3 (28.4 to 32.2) 20.6 (18.3 to 23.1)     Pain at the injection site: Mild (2305, 1159) 28.1 (26.3 to 30.0) 19.4 (17.2 to 21.8)     Pain at the injection site: Moderate (2305, 1159) 2.2 (1.6 to 2.8) 1.1 (0.6 to 1.9)     Pain at the injection site: Severe (2305, 1159) 0 (0.0 to 0.2) 0.1 (0.0 to 0.5)     Pain at the injection site: Grade 4 (2305, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.5)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of age [60]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)& G4 (necrosis[redness and swelling]or exfoliative dermatitis[redness]).Pain at injection site was graded as mild(did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity)&G4 ER visit or hospitalisation.G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included.Two-sided 95% CI was based on Clopper and Pearson method.Safety population=all participants who received at least 1 dose of study intervention.‘N’ signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 2094 1038 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (2094, 1038) 11.2 (9.9 to 12.7) 5.4 (4.1 to 6.9)     Redness: Mild (2094, 1038) 9.6 (8.3 to 10.9) 4.6 (3.4 to 6.1)     Redness: Moderate (2094, 1038) 1.6 (1.1 to 2.3) 0.8 (0.3 to 1.5)     Redness: Severe (2094, 1038) 0.0 (0.0 to 0.3) 0 (0.0 to 0.4)     Redness: Grade 4 (2094, 1038) 0.0 (0.0 to 0.2) 0 (0.0 to 0.4)     Swelling: Any (2094, 1038) 5.6 (4.7 to 6.7) 2.0 (1.3 to 3.1)     Swelling: Mild (2094, 1038) 4.4 (3.6 to 5.4) 1.8 (1.1 to 2.8)     Swelling: Moderate (2094, 1038) 1.2 (0.8 to 1.8) 0.2 (0.0 to 0.7)     Swelling: Severe (2094, 1038) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Swelling: Grade 4 (2094, 1038) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Pain at the injection site: Any (2082, 1037) 30.5 (28.5 to 32.5) 20.3 (17.9 to 22.9)     Pain at the injection site: Mild (2082, 1037) 28.2 (26.3 to 30.2) 19.4 (17.0 to 21.9)     Pain at the injection site: Moderate (2082, 1037) 2.2 (1.6 to 2.9) 0.9 (0.4 to 1.6)     Pain at the injection site: Severe (2082, 1037) 0 (0.0 to 0.2) 0.1 (0.0 to 0.5)     Pain at the injection site: Grade 4 (2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of age [61]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild(>=0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm),severe(>7.0 cm)& G4 (necrosis[redness and swelling]or exfoliative dermatitis[redness]).Pain at injection site was graded as mild(did not interfere with activity),moderate (interfered with activity),severe (prevented daily activity)&G4 ER visit or hospitalisation.G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included.Two-sided 95% CI was based on Clopper and Pearson method.Safety population=all participants who received at least 1 dose of study intervention.‘N’ signifies participants evaluable for this endpoint and ‘n’ signifies participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 799 376 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (799, 376) 10.4 (8.4 to 12.7) 4.8 (2.9 to 7.5)     Redness: Mild (799, 376) 9.0 (7.1 to 11.2) 4.0 (2.2 to 6.5)     Redness: Moderate (799, 376) 1.4 (0.7 to 2.4) 0.8 (0.2 to 2.3)     Redness: Severe (799, 376) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Redness: Grade 4 (799, 376) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Swelling: Any (799, 376) 3.1 (2.0 to 4.6) 1.6 (0.6 to 3.4)     Swelling: Mild (799, 376) 2.9 (1.8 to 4.3) 1.6 (0.6 to 3.4)     Swelling: Moderate (799, 376) 0.3 (0.0 to 0.9) 0 (0.0 to 1.0)     Swelling: Severe (799, 376) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Swelling: Grade 4 (799, 376) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Pain at the injection site: Any (793, 375) 28.0 (24.9 to 31.3) 12.8 (9.6 to 16.6)     Pain at the injection site: Mild (793, 375) 26.0 (23.0 to 29.2) 12.0 (8.9 to 15.7)     Pain at the injection site: Moderate (793, 375) 2.0 (1.2 to 3.3) 0.8 (0.2 to 2.3)     Pain at the injection site: Severe (793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Pain at the injection site: Grade 4 (793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of age [62]
End point description	Systemic events were recorded in an e-diary & at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1.Fever:oral temperature>= 38.0 deg C;categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C, >38.9 to 40.0 deg C & >40.0 deg C. Fatigue,headache,chills,new or worsened muscle pain and joint pain: mild(did not interfere with activity),moderate(some interference with activity),severe(prevented daily routine activity).Vomiting:mild: 1-2 times in 24 h,moderate:>2 times in 24 h, severe:required intravenous hydration.Diarrhea:mild:2-3 loose stools in 24 h,moderate:4-5 loose stools in 24 h,severe:6 or more loose stools in 24 h.G4 for all events: ER visit or hospitalisation& were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included.Exact 95%CI based on Clopper and Pearson method. Safety population.N=participants evaluable for endpoint & n=participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 2325 1164 Units: Percentage of participants number (confidence interval 95%)     Fever:>=38.0(n=2325, 1164) 5.5 (4.6 to 6.5) 5.7 (4.4 to 7.2)     Fever: 38.0 to 38.4 deg C (n=2325, 1164) 3.1 (2.4 to 3.8) 2.6 (1.7 to 3.7)     Fever: >38.4 to 38.9 deg C (n=2325, 1164) 1.5 (1.0 to 2.0) 2.1 (1.3 to 3.1)     Fever: >38.9 to 40.0 deg C (n=2325, 1164) 0.9 (0.6 to 1.4) 1.0 (0.5 to 1.8)     Fever: >40.0 deg C (n=2325, 1164) 0.1 (0.0 to 0.3) 0 (0.0 to 0.3)     Fatigue: Any (n=2304, 1159) 30.6 (28.7 to 32.5) 31.9 (29.2 to 34.7)     Fatigue: Mild (n=2304, 1159) 18.8 (17.2 to 20.4) 19.5 (17.3 to 21.9)     Fatigue: Moderate (n=2304, 1159) 11.5 (10.2 to 12.8) 11.6 (9.9 to 13.6)     Fatigue: Severe (n=2304, 1159) 0.4 (0.2 to 0.7) 0.8 (0.4 to 1.5)     Fatigue: Grade 4 (n=2304, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Headache: Any (n=2304, 1159) 5.1 (4.2 to 6.1) 4.8 (3.7 to 6.2)     Headache: Mild (n=2304, 1159) 3.9 (3.2 to 4.8) 3.7 (2.7 to 5.0)     Headache: Moderate (n=2304, 1159) 1.1 (0.7 to 1.6) 1.0 (0.5 to 1.8)     Headache: Severe (n=2304, 1159) 0 (0.0 to 0.2) 0.1 (0.0 to 0.5)     Headache: Grade 4 (n=2304, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Chills: Any (n=2304, 1159) 2.8 (2.1 to 3.5) 2.9 (2.0 to 4.1)     Chills: Mild (n=2304, 1159) 1.8 (1.3 to 2.4) 2.0 (1.3 to 3.0)     Chills: Moderate (n=2304, 1159) 0.9 (0.5 to 1.3) 0.9 (0.4 to 1.6)     Chills: Severe (n=2304, 1159) 0.1 (0.0 to 0.4) 0.1 (0.0 to 0.5)     Chills: Grade 4 (n=2304, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Vomiting: Any (n=2304, 1159) 3.5 (2.8 to 4.4) 2.9 (2.0 to 4.1)     Vomiting: Mild (n=2304, 1159) 2.9 (2.2 to 3.6) 2.1 (1.3 to 3.1)     Vomiting: Moderate (n=2304, 1159) 0.7 (0.4 to 1.1) 0.9 (0.4 to 1.6)     Vomiting: Severe (n=2304, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Vomiting: Grade 4 (n=2304, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Diarrhea: Any (n=2304, 1159) 8.6 (7.4 to 9.8) 8.3 (6.8 to 10.0)     Diarrhea: Mild (n=2304, 1159) 7.9 (6.8 to 9.0) 7.4 (6.0 to 9.1)     Diarrhea: Moderate (n=2304, 1159) 0.7 (0.4 to 1.1) 0.9 (0.4 to 1.6)     Diarrhea: Severe (n=2304, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     Diarrhea: Grade 4 (n=2304, 1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     New or worsened muscle pain:Any (n=2304,1159) 2.6 (2.0 to 3.3) 2.3 (1.5 to 3.4)     New or worsened muscle pain: Mild (n=2304,1159) 1.9 (1.4 to 2.6) 1.7 (1.1 to 2.7)     New or worsened muscle pain: Moderate(n=2304,1159) 0.7 (0.4 to 1.1) 0.5 (0.2 to 1.1)     New or worsened muscle pain: Severe(n=2304,1159) 0.0 (0.0 to 0.2) 0.1 (0.0 to 0.5)     New or worsened muscle pain: G4(n=2304,1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)     New or worsened joint pain: Any (n=2304,1159) 1.2 (0.8 to 1.7) 1.8 (1.1 to 2.8)     New or worsened joint pain:Mild (n=2304,1159) 0.9 (0.6 to 1.4) 1.4 (0.8 to 2.2)     New or worsened joint pain: Moderate(n=2304,1159) 0.2 (0.1 to 0.5) 0.4 (0.1 to 1.0)     New or worsened joint pain:Severe (n=2304,1159) 0.0 (0.0 to 0.2) 0 (0.0 to 0.3)     New or worsened joint pain: G4 (n=2304,1159) 0 (0.0 to 0.2) 0 (0.0 to 0.3)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of age [63]
End point description	Systemic events were recorded in an e-diary & at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2.Fever:oral temperature>= 38.0 deg C;categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C, >38.9 to 40.0 deg C & >40.0 deg C. Fatigue,headache,chills,new or worsened muscle pain and joint pain: mild(did not interfere with activity),moderate(some interference with activity),severe(prevented daily routine activity).Vomiting:mild: 1-2 times in 24 h,moderate:>2 times in 24 h, severe:required intravenous hydration.Diarrhea:mild:2-3 loose stools in 24 h,moderate:4-5 loose stools in 24 h,severe:6 or more loose stools in 24 h.G4 for all events: ER visit or hospitalisation& were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included.Exact 95%CI based on Clopper and Pearson method. Safety population.N=participants evaluable for endpoint & n=participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 2094 1038 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 (n=2094, 1038) 5.2 (4.3 to 6.2) 5.8 (4.4 to 7.4)     Fever:38.0 to 38.4 deg C (n=2094, 1038) 2.4 (1.8 to 3.2) 2.2 (1.4 to 3.3)     Fever: >38.4 to 38.9 deg C (n=2094, 1038) 1.5 (1.0 to 2.2) 2.6 (1.7 to 3.8)     Fever: >38.9 to 40.0 deg C (n=2094, 1038) 1.1 (0.7 to 1.6) 0.9 (0.4 to 1.6)     Fever: >40.0 deg C (n=2094, 1038) 0.1 (0.0 to 0.4) 0.1 (0.0 to 0.5)     Fatigue: Any (n=2082, 1037) 26.1 (24.2 to 28.0) 24.3 (21.7 to 27.0)     Fatigue: Mild (n=2082, 1037) 15.5 (13.9 to 17.1) 14.7 (12.6 to 17.0)     Fatigue: Moderate (n=2082, 1037) 10.2 (9.0 to 11.6) 9.3 (7.6 to 11.2)     Fatigue: Severe (n=2082, 1037) 0.4 (0.2 to 0.8) 0.4 (0.1 to 1.0)     Fatigue: Grade 4 (n=2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Headache: Any (n=2082, 1037) 4.6 (3.8 to 5.6) 4.1 (3.0 to 5.5)     Headache: Mild (n=2082, 1037) 3.5 (2.7 to 4.3) 2.6 (1.7 to 3.8)     Headache: Moderate (n=2082, 1037) 1.2 (0.7 to 1.7) 1.4 (0.8 to 2.4)     Headache: Severe (n=2082, 1037) 0 (0.0 to 0.2) 0.1 (0.0 to 0.5)     Headache: Grade 4 (n=2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Chills: Any (n=2082, 1037) 3.2 (2.5 to 4.0) 2.8 (1.9 to 4.0)     Chills: Mild (n=2082, 1037) 2.2 (1.6 to 2.9) 2.2 (1.4 to 3.3)     Chills: Moderate (n=2082, 1037) 1.0 (0.6 to 1.5) 0.6 (0.2 to 1.3)     Chills: Severe (n=2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Chills: Grade 4 (n=2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Vomiting: Any (n=2082, 1037) 3.4 (2.6 to 4.2) 3.4 (2.4 to 4.7)     Vomiting: Mild (n=2082, 1037) 3.0 (2.3 to 3.8) 2.9 (2.0 to 4.1)     Vomiting: Moderate (n=2082, 1037) 0.4 (0.2 to 0.8) 0.5 (0.2 to 1.1)     Vomiting: Severe (n=2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Vomiting: Grade 4 (n=2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     Diarrhea: Any (n=2082, 1037) 6.8 (5.7 to 7.9) 8.0 (6.4 to 9.8)     Diarrhea: Mild (n=2082, 1037) 5.9 (4.9 to 7.0) 7.1 (5.6 to 8.9)     Diarrhea: Moderate (n=2082, 1037) 0.8 (0.5 to 1.3) 0.8 (0.3 to 1.5)     Diarrhea: Severe (n=2082, 1037) 0.1 (0.0 to 0.3) 0.1 (0.0 to 0.5)     Diarrhea: Grade 4 (n=2082, 1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     New or worsened muscle pain: Any (n=2082, 1037) 2.6 (2.0 to 3.4) 2.6 (1.7 to 3.8)     New or worsened muscle pain:Mild (n=2082,1037) 1.9 (1.3 to 2.6) 2.0 (1.3 to 3.1)     New or worsened muscle pain: Moderate(n=2082,1037) 0.8 (0.4 to 1.2) 0.6 (0.2 to 1.3)     New or worsened muscle pain: Severe(n=2082,1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     New or worsened muscle pain: G4 (n=2082,1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     New or worsened joint pain:Any (n=2082,1037) 1.2 (0.8 to 1.8) 1.2 (0.6 to 2.0)     New or worsened joint pain:Mild (n=2082,1037) 0.9 (0.6 to 1.4) 0.9 (0.4 to 1.6)     New or worsened joint pain: Moderate(n=2082,1037) 0.3 (0.1 to 0.7) 0.3 (0.1 to 0.8)     New or worsened joint pain:Severe (n=2082,1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)     New or worsened joint pain:G4 (n=2082,1037) 0 (0.0 to 0.2) 0 (0.0 to 0.4)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of age [64]
End point description	Systemic events were recorded in an e-diary & at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3.Fever:oral temperature>= 38.0 deg C;categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C, >38.9 to 40.0 deg C & >40.0 deg C. Fatigue,headache,chills,new or worsened muscle pain and joint pain: mild(did not interfere with activity),moderate(some interference with activity),severe(prevented daily routine activity).Vomiting:mild: 1-2 times in 24 h,moderate:>2 times in 24 h, severe:required intravenous hydration.Diarrhea:mild:2-3 loose stools in 24 h,moderate:4-5 loose stools in 24 h,severe:6 or more loose stools in 24 h.G4 for all events: ER visit or hospitalisation& were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included.Exact 95%CI based on Clopper and Pearson method. Safety population.N=participants evaluable for endpoint & n=participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 799 376 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 (n=799, 376) 5.1 (3.7 to 6.9) 5.6 (3.5 to 8.4)     Fever:38.0 to 38.4 deg C (n=799, 376) 2.5 (1.5 to 3.8) 2.1 (0.9 to 4.1)     Fever: >38.4 to 38.9 deg C (n=799, 376) 1.8 (1.0 to 2.9) 1.9 (0.8 to 3.8)     Fever: >38.9 to 40.0 deg C (n=799, 376) 0.9 (0.4 to 1.8) 1.6 (0.6 to 3.4)     Fever: >40.0 deg C (n=799, 376) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Fatigue: Any (n=793, 375) 25.5 (22.5 to 28.7) 24.3 (20.0 to 28.9)     Fatigue: Mild (n=793, 375) 16.0 (13.5 to 18.8) 14.7 (11.2 to 18.7)     Fatigue: Moderate (n=793, 375) 9.2 (7.3 to 11.4) 9.3 (6.6 to 12.7)     Fatigue: Severe (n=793, 375) 0.3 (0.0 to 0.9) 0.3 (0.0 to 1.5)     Fatigue: Grade 4 (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Headache: Any (n=793, 375) 4.5 (3.2 to 6.2) 4.0 (2.3 to 6.5)     Headache: Mild (n=793, 375) 2.9 (1.8 to 4.3) 2.9 (1.5 to 5.2)     Headache: Moderate (n=793, 375) 1.6 (0.9 to 2.8) 1.1 (0.3 to 2.7)     Headache: Severe (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Headache: Grade 4 (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Chills: Any (n=793, 375) 2.8 (1.7 to 4.2) 2.7 (1.3 to 4.8)     Chills: Mild (n=793, 375) 2.1 (1.3 to 3.4) 2.4 (1.1 to 4.5)     Chills: Moderate (n=793, 375) 0.5 (0.1 to 1.3) 0.3 (0.0 to 1.5)     Chills: Severe (n=793, 375) 0.1 (0.0 to 0.7) 0 (0.0 to 1.0)     Chills: Grade 4 (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Vomiting: Any (n=793, 375) 2.0 (1.2 to 3.3) 4.3 (2.5 to 6.8)     Vomiting: Mild (n=793, 375) 1.5 (0.8 to 2.6) 2.9 (1.5 to 5.2)     Vomiting: Moderate (n=793, 375) 0.5 (0.1 to 1.3) 1.3 (0.4 to 3.1)     Vomiting: Severe (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Vomiting: Grade 4 (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Diarrhea: Any (n=793, 375) 4.9 (3.5 to 6.7) 5.6 (3.5 to 8.4)     Diarrhea: Mild (n=793, 375) 3.8 (2.6 to 5.4) 4.5 (2.7 to 7.2)     Diarrhea: Moderate (n=793, 375) 1.1 (0.5 to 2.1) 1.1 (0.3 to 2.7)     Diarrhea: Severe (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     Diarrhea: Grade 4 (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     New or worsened muscle pain: Any (n=793, 375) 1.9 (1.1 to 3.1) 1.6 (0.6 to 3.4)     New or worsened muscle pain: Mild (n=793, 375) 1.5 (0.8 to 2.6) 1.3 (0.4 to 3.1)     New or worsened muscle pain: Moderate (n=793, 375) 0.4 (0.1 to 1.1) 0.3 (0.0 to 1.5)     New or worsened muscle pain: Severe (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     New or worsened muscle pain: Grade 4 (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)     New or worsened joint pain: Any (n=793, 375) 1.1 (0.5 to 2.1) 1.1 (0.3 to 2.7)     New or worsened joint pain: Mild (n=793, 375) 0.9 (0.4 to 1.8) 1.1 (0.3 to 2.7)     New or worsened joint pain: Moderate (n=793, 375) 0.1 (0.0 to 0.7) 0 (0.0 to 1.0)     New or worsened joint pain: Severe (n=793, 375) 0.1 (0.0 to 0.7) 0 (0.0 to 1.0)     New or worsened joint pain: Grade 4 (n=793, 375) 0 (0.0 to 0.5) 0 (0.0 to 1.0)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of age [65]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where,1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) & G4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate(hurts if gently touched with crying), severe (causes limitation of limb movement) & G4 (ER visit or hospitalisation).G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population was used. ‘N=participants evaluable for this endpoint and ‘n=participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 1439 712 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (n=1439, 712) 10.7 (9.2 to 12.4) 7.6 (5.7 to 9.8)     Redness: Mild (n=1439, 712) 9.8 (8.3 to 11.5) 7.2 (5.4 to 9.3)     Redness: Moderate (n=1439, 712) 0.9 (0.5 to 1.5) 0.4 (0.1 to 1.2)     Redness: Severe (n=1439, 712) 0 (0.0 to 0.3) 0 (0.0 to 0.5)     Redness: Grade 4 (n=1439, 712) 0 (0.0 to 0.3) 0 (0.0 to 0.5)     Swelling: Any (n=1439, 712) 3.8 (2.8 to 4.9) 2.5 (1.5 to 4.0)     Swelling: Mild (n=1439, 712) 3.3 (2.5 to 4.4) 2.2 (1.3 to 3.6)     Swelling: Moderate (n=1439, 712) 0.4 (0.2 to 0.9) 0.3 (0.0 to 1.0)     Swelling: Severe (n=1439, 712) 0 (0.0 to 0.3) 0 (0.0 to 0.5)     Swelling: Grade 4 (n=1439, 712) 0 (0.0 to 0.3) 0 (0.0 to 0.5)     Tenderness at injection site: Any (n=1425, 706) 17.2 (15.3 to 19.3) 12.6 (10.2 to 15.3)     Tenderness at injection site: Mild (n=1425, 706) 16.3 (14.4 to 18.3) 11.5 (9.2 to 14.1)     Tenderness at injection site:Moderate (n=1425,706) 0.8 (0.4 to 1.5) 1.1 (0.5 to 2.2)     Tenderness at injection site:Severe(n=1425,706) 0.1 (0.0 to 0.4) 0 (0.0 to 0.5)     Tenderness at injection site: G4 (n=1425, 706) 0 (0.0 to 0.3) 0 (0.0 to 0.5)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of age [66]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where,1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) & G4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate(hurts if gently touched with crying), severe (causes limitation of limb movement) & G4 (ER visit or hospitalisation).G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population was used. ‘N=participants evaluable for this endpoint and ‘n=participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 1323 666 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (n= 1323,666) 9.9 (8.3 to 11.6) 6.3 (4.6 to 8.4)     Redness: Mild (n= 1323,666) 9.1 (7.6 to 10.7) 5.9 (4.2 to 7.9)     Redness: Moderate (n= 1323,666) 0.8 (0.4 to 1.5) 0.5 (0.1 to 1.3)     Redness: Severe (n= 1323,666) 0 (0.0 to 0.3) 0 (0.0 to 0.6)     Redness: Grade 4 (n= 1323,666) 0 (0.0 to 0.3) 0 (0.0 to 0.6)     Swelling: Any (n= 1323,666) 4.1 (3.1 to 5.3) 1.5 (0.7 to 2.7)     Swelling: Mild (n= 1323,666) 3.5 (2.6 to 4.6) 1.4 (0.6 to 2.5)     Swelling: Moderate (n= 1323,666) 0.6 (0.3 to 1.2) 0.2 (0.0 to 0.8)     Swelling: Severe (n= 1323,666) 0 (0.0 to 0.3) 0 (0.0 to 0.6)     Swelling: Grade 4 (n= 1323,666) 0 (0.0 to 0.3) 0 (0.0 to 0.6)     Tenderness at injection site: Any(n= 1314,664) 15.4 (13.5 to 17.5) 9.3 (7.2 to 11.8)     Tenderness at injection site:Mild (n= 1314,664) 13.8 (12.0 to 15.8) 7.7 (5.8 to 10.0)     Tenderness at injection site:Moderate(n=1314,664) 1.6 (1.0 to 2.4) 1.7 (0.8 to 2.9)     Tenderness at injection site:Severe (n= 1314,664) 0.1 (0.0 to 0.4) 0 (0.0 to 0.6)     Tenderness at injection site: G4 (n= 1314,664) 0 (0.0 to 0.3) 0 (0.0 to 0.6)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of age [67]
End point description	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where,1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) & G4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate(hurts if gently touched with crying), severe (causes limitation of limb movement) & G4 (ER visit or hospitalisation).G4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population was used. ‘N=participants evaluable for this endpoint and ‘n=participants evaluable for the specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 459 222 Units: Percentage of participants number (confidence interval 95%)     Redness: Any (n=459,222) 7.2 (5.0 to 9.9) 5.0 (2.5 to 8.7)     Redness: Mild (n=459,222) 5.0 (3.2 to 7.4) 4.5 (2.2 to 8.1)     Redness: Moderate (n=459,222) 2.0 (0.9 to 3.7) 0.5 (0.0 to 2.5)     Redness: Severe (n=459,222) 0.2 (0.0 to 1.2) 0 (0.0 to 1.6)     Redness: Grade 4 (n=459,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)     Swelling: Any (n=459,222) 3.3 (1.8 to 5.3) 2.3 (0.7 to 5.2)     Swelling: Mild (n=459,222) 2.0 (0.9 to 3.7) 2.3 (0.7 to 5.2)     Swelling: Moderate (n=459,222) 1.3 (0.5 to 2.8) 0 (0.0 to 1.6)     Swelling: Severe (n=459,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)     Swelling: Grade 4 (n=459,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)     Tenderness at injection site:Any (n=455,222) 14.7 (11.6 to 18.3) 9.9 (6.3 to 14.6)     Tenderness at injection site:Mild (n=455,222) 13.0 (10.0 to 16.4) 8.6 (5.2 to 13.0)     Tenderness at injection site: Moderate(n=455,222) 1.8 (0.8 to 3.4) 1.4 (0.3 to 3.9)     Tenderness at injection site:Severe (n=455,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)     Tenderness at injection site: G4 (n=455,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of age [68]
End point description	Systemic events recorded in an e-diary & at unscheduled clinical assessments up to Day 7 after Dose 1. Fever: oral temperature >= 38.0 deg C; categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C, >38.9 to 40.0 deg C & >40.0 deg C. Decreased appetite: mild (decreased interest in eating),moderate(decreased oral intake),severe(refusal to feed). Drowsiness: mild(increased or prolonged sleeping bouts),moderate(slightly subdued interfering with daily activity),severe(disabling;not interested in usual daily activity).Irritability:mild(easily consolable),moderate(requiring increased attention),severe(Inconsolable; crying cannot be comforted).G4 for all events: ER visit or hospitalisation & were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population. N=participants evaluable for this endpoint & n=participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 1
Notes [68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 1439 712 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 (n=1439,712) 7.2 (5.9 to 8.7) 7.4 (5.6 to 9.6)     Fever: 38.0 to 38.4 deg C (n=1439,712) 3.4 (2.5 to 4.5) 3.5 (2.3 to 5.1)     Fever: >38.4 to 38.9 deg C (n=1439,712) 2.2 (1.5 to 3.1) 2.5 (1.5 to 4.0)     Fever: >38.9 to 40.0 deg C (n=1439,712) 1.5 (1.0 to 2.3) 1.3 (0.6 to 2.4)     Fever: >40.0 deg C (n=1439,712) 0.1 (0.0 to 0.4) 0.1 (0.0 to 0.8)     Decreased appetite: Any (n=1425,706) 22.7 (20.5 to 24.9) 21.2 (18.3 to 24.5)     Decreased appetite: Mild (n=1425,706) 12.4 (10.7 to 14.2) 12.0 (9.7 to 14.7)     Decreased appetite: Moderate (n=1425,706) 10.1 (8.6 to 11.8) 8.9 (6.9 to 11.3)     Decreased appetite: Severe (n=1425,706) 0.2 (0.0 to 0.6) 0.3 (0.0 to 1.0)     Decreased appetite: Grade 4 (n=1425,706) 0 (0.0 to 0.3) 0 (0.0 to 0.5)     Drowsiness: Any (n=1425,706) 27.8 (25.5 to 30.2) 30.0 (26.7 to 33.6)     Drowsiness: Mild (n=1425,706) 22.0 (19.8 to 24.2) 22.7 (19.6 to 25.9)     Drowsiness: Moderate (n=1425,706) 5.6 (4.5 to 6.9) 6.9 (5.2 to 9.1)     Drowsiness: Severe (n=1425,706) 0.2 (0.0 to 0.6) 0.4 (0.1 to 1.2)     Drowsiness: Grade 4 (n=1425,706) 0 (0.0 to 0.3) 0 (0.0 to 0.5)     Irritability: Any (n=1425,706) 51.0 (48.4 to 53.6) 48.2 (44.4 to 51.9)     Irritability: Mild (n=1425,706) 20.6 (18.6 to 22.8) 18.3 (15.5 to 21.3)     Irritability: Moderate (n=1425,706) 29.7 (27.3 to 32.1) 29.6 (26.3 to 33.1)     Irritability: Severe (n=1425,706) 0.7 (0.3 to 1.3) 0.3 (0.0 to 1.0)     Irritability: Grade 4 (n=1425,706) 0 (0.0 to 0.3) 0 (0.0 to 0.5)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of age [69]
End point description	Systemic events recorded in an e-diary & at unscheduled clinical assessments up to Day 7 after Dose 2. Fever: oral temperature >= 38.0 deg C; categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C, >38.9 to 40.0 deg C & >40.0 deg C. Decreased appetite: mild (decreased interest in eating),moderate(decreased oral intake),severe(refusal to feed). Drowsiness: mild(increased or prolonged sleeping bouts),moderate(slightly subdued interfering with daily activity),severe(disabling;not interested in usual daily activity).Irritability:mild(easily consolable),moderate(requiring increased attention),severe(Inconsolable; crying cannot be comforted).G4 for all events: ER visit or hospitalisation & were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population. N=participants evaluable for this endpoint & n=participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 2
Notes [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 1322 666 Units: Percentage of participants number (confidence interval 95%)     Fever: >=38.0 (n=1322,666) 7.6 (6.3 to 9.2) 6.5 (4.7 to 8.6)     Fever: 38.0 to 38.4 deg C (n=1322,666) 3.6 (2.7 to 4.8) 3.6 (2.3 to 5.3)     Fever: >38.4 to 38.9 deg C (n=1322,666) 2.0 (1.4 to 3.0) 1.7 (0.8 to 2.9)     Fever: >38.9 to 40.0 deg C (n=1322,666) 1.9 (1.2 to 2.8) 1.2 (0.5 to 2.4)     Fever: >40.0 deg C (n=1322,666) 0.1 (0.0 to 0.4) 0 (0.0 to 0.6)     Decreased appetite: Any (n=1314,664) 22.5 (20.3 to 24.9) 19.4 (16.5 to 22.6)     Decreased appetite: Mild (n=1314,664) 13.9 (12.1 to 15.9) 11.3 (9.0 to 14.0)     Decreased appetite: Moderate (n=1314,664) 8.1 (6.7 to 9.8) 8.0 (6.0 to 10.3)     Decreased appetite: Severe (n=1314,664) 0.5 (0.2 to 1.0) 0.2 (0.0 to 0.8)     Decreased appetite: Grade 4 (n=1314,664) 0 (0.0 to 0.3) 0 (0.0 to 0.6)     Drowsiness: Any (n=1314,664) 24.1 (21.8 to 26.5) 21.4 (18.3 to 24.7)     Drowsiness: Mild (n=1314,664) 17.8 (15.8 to 20.0) 16.9 (14.1 to 19.9)     Drowsiness: Moderate (n=1314,664) 6.0 (4.8 to 7.4) 4.4 (2.9 to 6.2)     Drowsiness: Severe (n=1314,664) 0.3 (0.1 to 0.8) 0.2 (0.0 to 0.8)     Drowsiness: Grade 4 (n=1314,664) 0 (0.0 to 0.3) 0 (0.0 to 0.6)     Irritability: Any (n=1314,664) 46.9 (44.2 to 49.6) 41.4 (37.6 to 45.3)     Irritability: Mild (n=1314,664) 18.5 (16.4 to 20.7) 15.8 (13.1 to 18.8)     Irritability: Moderate (n=1314,664) 27.8 (25.4 to 30.3) 24.7 (21.5 to 28.2)     Irritability: Severe (n=1314,664) 0.6 (0.3 to 1.2) 0.9 (0.3 to 2.0)     Irritability: Grade 4 (n=1314,664) 0 (0.0 to 0.3) 0 (0.0 to 0.6)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of age [70]
End point description	Systemic events recorded in an e-diary & at unscheduled clinical assessments up to Day 7 after Dose 3. Fever: oral temperature >= 38.0 deg C; categorised as >=38.0 to 38.4 deg C,>38.4 to 38.9 deg C, >38.9 to 40.0 deg C & >40.0 deg C. Decreased appetite: mild (decreased interest in eating),moderate(decreased oral intake),severe(refusal to feed). Drowsiness: mild(increased or prolonged sleeping bouts),moderate(slightly subdued interfering with daily activity),severe(disabling;not interested in usual daily activity).Irritability:mild(easily consolable),moderate(requiring increased attention),severe(Inconsolable; crying cannot be comforted).G4 for all events: ER visit or hospitalisation & were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population. N=participants evaluable for this endpoint & n=participants evaluable for specified rows.
End point type	Primary
End point timeframe	Day 1 to Day 7 after Dose 3
Notes [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 459 222 Units: Percentage of participants number (confidence interval 95%)     Fever:>=38.0 (n=459,222) 6.1 (4.1 to 8.7) 5.9 (3.2 to 9.8)     Fever:38.0 to 38.4 deg C (n=459,222) 3.3 (1.8 to 5.3) 3.2 (1.3 to 6.4)     Fever: >38.4 to 38.9 deg C (n=459,222) 1.3 (0.5 to 2.8) 1.8 (0.5 to 4.5)     Fever: >38.9 to 40.0 deg C (n=459,222) 1.1 (0.4 to 2.5) 0.9 (0.1 to 3.2)     Fever: >40.0 deg C (n=459,222) 0.4 (0.1 to 1.6) 0 (0.0 to 1.6)     Decreased appetite: Any (n=455,222) 19.6 (16.0 to 23.5) 13.1 (8.9 to 18.2)     Decreased appetite: Mild (n=455,222) 11.2 (8.5 to 14.5) 7.2 (4.2 to 11.4)     Decreased appetite: Moderate (n=455,222) 7.5 (5.2 to 10.3) 5.9 (3.2 to 9.8)     Decreased appetite: Severe (n=455,222) 0.9 (0.2 to 2.2) 0 (0.0 to 1.6)     Decreased appetite: Grade 4 (n=455,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)     Drowsiness: Any (n=455,222) 21.5 (17.8 to 25.6) 12.2 (8.2 to 17.2)     Drowsiness: Mild (n=455,222) 15.8 (12.6 to 19.5) 9.0 (5.6 to 13.6)     Drowsiness: Moderate (n=455,222) 5.3 (3.4 to 7.7) 2.7 (1.0 to 5.8)     Drowsiness: Severe (n=455,222) 0.4 (0.1 to 1.6) 0.5 (0.0 to 2.5)     Drowsiness: Grade 4 (n=455,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)     Irritability: Any (n=455,222) 42.0 (37.4 to 46.7) 36.9 (30.6 to 43.7)     Irritability: Mild (n=455,222) 15.8 (12.6 to 19.5) 15.3 (10.8 to 20.7)     Irritability: Moderate (n=455,222) 25.7 (21.8 to 30.0) 21.6 (16.4 to 27.6)     Irritability: Severe (n=455,222) 0.4 (0.1 to 1.6) 0 (0.0 to 1.6)     Irritability: Grade 4 (n=455,222) 0 (0.0 to 0.8) 0 (0.0 to 1.6)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of age [71]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.
End point type	Primary
End point timeframe	From Dose 1 to 1 month after Dose 2
Notes [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 3109 1538 Units: Percentage of participants     number (confidence interval 95%) 10.7 (9.6 to 11.9) 9.8 (8.3 to 11.3)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of age [72]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 3 to 1 month after Dose 3
Notes [72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Number of subjects analysed 2408 Units: Percentage of participants     number (confidence interval 95%) 8.0 (7.0 to 9.2)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=5 to <12 Years of age [73]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 3109 1538 Units: Percentage of participants     number (confidence interval 95%) 0.3 (0.1 to 0.5) 0.1 (0.0 to 0.5)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of age [74]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention.‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 3 to 6 months after Dose 3 (Approximately 6 months)
Notes [74] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Number of subjects analysed 2408 Units: Percentage of participants     number (confidence interval 95%) 0.4 (0.2 to 0.8)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of age [75]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 1 to 1 month after Dose 2
Notes [75] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 2350 1173 Units: Percentage of participants     number (confidence interval 95%) 13.1 (11.8 to 14.6) 13.0 (11.1 to 15.0)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3:>=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3:>=2 to <5 Years of age [76]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 3 to 1 month after Dose 3
Notes [76] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 863 405 Units: Percentage of participants     number (confidence interval 95%) 4.5 (3.2 to 6.1) 6.4 (4.2 to 9.3)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3:>=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of age [77]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 2350 1173 Units: Percentage of participants     number (confidence interval 95%) 0.5 (0.2 to 0.8) 0.9 (0.4 to 1.6)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3:>=2 to <5 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3:>=2 to <5 Years of age [78]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 3 to 6 months after Dose 3 (Approximately 6 months)
Notes [78] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 863 405 Units: Percentage of participants     number (confidence interval 95%) 0.3 (0.1 to 1.0) 0 (0.0 to 0.9)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3:>=2 to <5 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2 : >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2 : >=6 Months to <2 Years of age [79]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 1 to 1 month after dose 2 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 1 to 1 month after Dose 2
Notes [79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 1447 718 Units: Percentage of participants     number (confidence interval 95%) 21.5 (19.4 to 23.7) 19.9 (17.1 to 23.0)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2 : >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3 : >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3 : >=6 Months to <2 Years of age [80]
End point description	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs after dose 3 to 1 month after dose 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all participants who received at least 1 dose of the study intervention.‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 3 to 1 month after Dose 3
Notes [80] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 483 237 Units: Percentage of participants     number (confidence interval 95%) 10.4 (7.8 to 13.4) 7.6 (4.6 to 11.7)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3 : >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=6 Months to <2 Years of age [81]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 1 to 6 months after Dose 2
Notes [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 1447 718 Units: Percentage of participants     number (confidence interval 95%) 1.7 (1.1 to 2.5) 2.4 (1.4 to 3.8)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : >=6 Months to <2 Years of age Top of page
End point title	Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : >=6 Months to <2 Years of age [82]
End point description	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention. ‘N’ signifies participants evaluable for this endpoint.
End point type	Primary
End point timeframe	From Dose 3 to 6 months after Dose 3 (Approximately 6 months)
Notes [82] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This endpoint was planned to be analysed only for the specified reporting arms.
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 483 237 Units: Percentage of participants     number (confidence interval 95%) 0.2 (0.0 to 1.1) 0 (0.0 to 1.5)
No statistical analyses for this end point

Primary: Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : >=6 Months to <2 Years of age Top of page

Primary: Phase 2/3: Geometric Mean Ratio (GMR) for SARS-CoV-2 Neutralizing Titers in Participants >=5 to <12 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study:1 Month After Dose 2:Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Geometric Mean Ratio (GMR) for SARS-CoV-2 Neutralizing Titers in Participants >=5 to <12 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study:1 Month After Dose 2:Participants Without Evidence of Infection
End point description	GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of the titers and the corresponding CIs(based on student t distribution).Assay results below the lower limit of quantitation(LLOQ))were set to 0.5*LLOQ.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants of the age 16 to 25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 were also included.Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised,had a valid and determinate immunogenicity result within 28-42 days after the study vaccination,and had no other important protocol deviations as determined by the clinician.N=participants evaluable.GMT is reported in descriptive analysis & GMR is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=5 to <12 years):1 month after Dose 2 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 264 253 Units: Titers     geometric mean (confidence interval 95%) 1197.6 (1106.1 to 1296.6) 1146.5 (1045.5 to 1257.2)
Statistical analysis title	Geometric Mean Ratio
Statistical analysis description	Phase 2/3: Geometric Mean Ratio for SARS-CoV-2 Neutralizing Titers in Participants >=5 to <12 Years of age to Participants 16 to 25 Years of age from Phase 2/3 of the C4591001 Study : 1 Month after Dose 2
Comparison groups	Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	517
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio
Point estimate	1.04
Confidence interval
level	95%
sides	2-sided
lower limit	0.93
upper limit	1.18

Primary: Phase 2/3: Geometric Mean Ratio (GMR) for SARS-CoV-2 Neutralizing Titers in Participants >=5 to <12 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study:1 Month After Dose 2:Participants Without Evidence of Infection Top of page

Primary: Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=5 to <12 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=5 to <12 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection
End point description	Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint. Percentage of participants with seroresponse is reported in descriptive analysis and the difference in percentage of participants is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=5 to <12 years):1 month after Dose 2 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 264 253 Units: Percentage of participants     number (confidence interval 95%) 99.2 (97.3 to 99.9) 99.2 (97.2 to 99.9)
Statistical analysis title	Difference in Percentages
Statistical analysis description	Difference in Percentages of Participants With Seroresponse – Participants Without Evidence of Infection up to 1 Month After Dose 2 – Immunobridging Subset – Phase 2/3 – Comparison of 5 to <12 Years of Age to Study C4591001 Phase 2/3 – 16 Through 25 Years of Age
Comparison groups	Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	517
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Difference in percentage
Point estimate	0
Confidence interval
level	95%
sides	2-sided
lower limit	-2
upper limit	2.2

Primary: Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=5 to <12 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page

Primary: Phase 2/3: GMR for SARS-CoV-2 Neutralizing Titers in Participants >=2 to <5 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: GMR for SARS-CoV-2 Neutralizing Titers in Participants >=2 to <5 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection
End point description	GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of the titers and the corresponding CIs(based on student t distribution).Assay results below the lower limit of quantitation(LLOQ))were set to 0.5*LLOQ.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants of the age 16 to 25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 were also included.Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised,had a valid and determinate immunogenicity result within 28-42 days after the study vaccination,and had no other important protocol deviations as determined by the clinician.N=participants evaluable.GMT is reported in descriptive analysis & GMR is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=2 to <5 years):1 month after Dose 2 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 243 252 Units: Titers     geometric mean (confidence interval 95%) 763.9 (688.5 to 847.5) 1255.4 (1131.2 to 1393.3)
Statistical analysis title	Geometric Mean Ratio
Statistical analysis description	Geometric Mean Ratio for SARS-CoV-2 Neutralizing Titers in Participants >=2 to <5 Years of age to Participants 16 to 25 Years of age from Phase 2/3 of the C4591001 study : at 1 Month after Dose- 2 Phase 2/3
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	495
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio
Point estimate	0.61
Confidence interval
level	95%
sides	2-sided
lower limit	0.53
upper limit	0.7

Primary: Phase 2/3: GMR for SARS-CoV-2 Neutralizing Titers in Participants >=2 to <5 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page

Primary: Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=2 to <5 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=2 to <5 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection
End point description	Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint. Percentage of participants with seroresponse is reported in descriptive analysis and the difference in percentage of participants is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=2 to <5 years):1 month after Dose 2 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 243 251 Units: Percentage of Participants     number (confidence interval 95%) 96.7 (93.6 to 98.6) 97.6 (94.9 to 99.1)
Statistical analysis title	Difference in Percentage
Statistical analysis description	Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=2 to <5 Years of age and 16 to 25 Years of age from Phase 2/3 of the C4591001 study : 1 Month after Dose 2
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	494
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Difference in Percentage
Point estimate	-0.9
Confidence interval
level	95%
sides	2-sided
lower limit	-4.3
upper limit	2.3

Primary: Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=2 to <5 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page

Primary: Phase 2/3: GMR for SARS-CoV-2 Neutralizing Titers in Participants >=6 Months to <2 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: GMR for SARS-CoV-2 Neutralizing Titers in Participants >=6 Months to <2 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection
End point description	GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of the titers and the corresponding CIs(based on student t distribution).Assay results below the lower limit of quantitation(LLOQ))were set to 0.5*LLOQ.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants of the age 16 to 25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 were also included.Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised,had a valid and determinate immunogenicity result within 28-42 days after the study vaccination,and had no other important protocol deviations as determined by the clinician.N=participants evaluable.GMT is reported in descriptive analysis & GMR is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=6 months to <2 years):1 month after Dose 2 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 245 238 Units: Titers     geometric mean (confidence interval 95%) 979.7 (893.2 to 1074.6) 946.8 (850.8 to 1053.7)
Statistical analysis title	Geometric Mean Ratio
Statistical analysis description	Phase 2/3: Geometric Mean Ratio for SARS-CoV-2 Neutralizing Titers in Participants >=6 Months to <2 Years of age to Participants 16 to 25 Years of age from Phase 2/3 of the C4591001 study : at 1 Month after Dose 2
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	483
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric Mean Ratio
Point estimate	1.03
Confidence interval
level	95%
sides	2-sided
lower limit	0.9
upper limit	1.19

Primary: Phase 2/3: GMR for SARS-CoV-2 Neutralizing Titers in Participants >=6 Months to <2 Years of age to Participants 16 to 25 Years of age From Phase 2/3 of the C4591001 Study : 1 Month After Dose 2: Participants Without Evidence of Infection Top of page

Primary: Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=6 Months to <2 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study: 1 Month After Dose 2: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=6 Months to <2 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study: 1 Month After Dose 2: Participants Without Evidence of Infection
End point description	Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint. Percentage of participants with seroresponse is reported in descriptive analysis and the difference in percentage of participants is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=6 months to <2 years):1 month after Dose 2 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 245 238 Units: Percentage of Participants     number (confidence interval 95%) 98.0 (95.3 to 99.3) 96.2 (92.9 to 98.3)
Statistical analysis title	Difference in Percentage
Statistical analysis description	Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=6 Months to <2 Years of age and 16 to 25 Years of age from Phase 2/3 of the C4591001 study : 1 Month after Dose 2
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	483
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Difference in Percentage
Point estimate	1.7
Confidence interval
level	95%
sides	2-sided
lower limit	-1.4
upper limit	5.2

Primary: Phase 2/3: Difference in Percentage of Participants who Achieved Seroresponse in >=6 Months to <2 Years of age and 16 to 25 Years of age From Phase 2/3 of the C4591001 Study: 1 Month After Dose 2: Participants Without Evidence of Infection Top of page

Primary: Phase 2/3:GMR for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged >=2 to <5 Years to Those at 1 Month After Dose 2 in Participants Aged 16 to 25 Years From Phase 2/3 of C4591001 Study:Participants Without Evidence of Infection Top of page
End point title	Phase 2/3:GMR for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged >=2 to <5 Years to Those at 1 Month After Dose 2 in Participants Aged 16 to 25 Years From Phase 2/3 of C4591001 Study:Participants Without Evidence of Infection
End point description	GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of the titers and the corresponding CIs(based on student t distribution).Assay results below the lower limit of quantitation(LLOQ))were set to 0.5*LLOQ.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants of the age 16 to 25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 were also included.Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised,had a valid and determinate immunogenicity result within 28-42 days after the study vaccination,and had no other important protocol deviations as determined by the clinician.N=participants evaluable.GMT is reported in descriptive analysis & GMR is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=2 to <5 years):1 month after Dose 2 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 143 170 Units: Titers     geometric mean (confidence interval 95%) 1535.2 (1388.2 to 1697.8) 1180.0 (1066.6 to 1305.4)
Statistical analysis title	Geometric Mean Ratio
Statistical analysis description	Phase 2/3: Geometric Mean Ratio for SARS-CoV-2 Neutralizing Titers at 1 Month after dose 3 in Participants >=2 to <5 Years of age to those at 1 month after Dose 2 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	313
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric Mean Ratio
Point estimate	1.3
Confidence interval
level	95%
sides	2-sided
lower limit	1.13
upper limit	1.5

Primary: Phase 2/3:GMR for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged >=2 to <5 Years to Those at 1 Month After Dose 2 in Participants Aged 16 to 25 Years From Phase 2/3 of C4591001 Study:Participants Without Evidence of Infection Top of page

Primary: Phase 2/3:Difference in Percentage of Participants With Seroresponse in 2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 Through 25 Years of Age: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3:Difference in Percentage of Participants With Seroresponse in 2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 Through 25 Years of Age: Participants Without Evidence of Infection
End point description	Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint. Percentage of participants with seroresponse is reported in descriptive analysis and the difference in percentage of participants is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=2 to <5 years):1 month after Dose 3 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 141 170 Units: Percentage of participants     number (confidence interval 95%) 100.0 (97.4 to 100.0) 98.8 (95.8 to 99.9)
Statistical analysis title	Difference in Percentages
Statistical analysis description	Phase 2/3: Difference in Percentages of Participants With Seroresponse – Participants Without Evidence of Infection – Immunobridging Subset – Comparison of Study C4591007 Phase 2/3 2 to <5 Years of Age (1 Month After Dose 3) and Study C4591001 Phase 2/3 16 Through 25 Years of Age (1 Month After Dose 2)
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	311
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Difference in Percentages
Point estimate	1.2
Confidence interval
level	95%
sides	2-sided
lower limit	-1.5
upper limit	4.2

Primary: Phase 2/3:Difference in Percentage of Participants With Seroresponse in 2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 Through 25 Years of Age: Participants Without Evidence of Infection Top of page

Primary: Phase 2/3:GMR for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged 6 Months to 2 Years to Those at 1 Month After Dose 3 in Participants Aged 16 to 25 Years From Phase 2/3 of C4591001:Participants Without Evidence of Infection Top of page
End point title	Phase 2/3:GMR for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged 6 Months to 2 Years to Those at 1 Month After Dose 3 in Participants Aged 16 to 25 Years From Phase 2/3 of C4591001:Participants Without Evidence of Infection
End point description	GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of the titers and the corresponding CIs(based on student t distribution).Assay results below the lower limit of quantitation(LLOQ))were set to 0.5*LLOQ.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants of the age 16 to 25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 were also included.Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised,had a valid and determinate immunogenicity result within 28-42 days after the study vaccination,and had no other important protocol deviations as determined by the clinician.N=participants evaluable.GMT is reported in descriptive analysis & GMR is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=2 to <5 years):1 month after Dose 3 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 82 170 Units: Titers     geometric mean (confidence interval 95%) 1406.5 (1211.3 to 1633.1) 1180.0 (1066.6 to 1305.4)
Statistical analysis title	Geometric Mean Ratio
Statistical analysis description	Phase 2/3: Geometric Mean Ratio for SARS-CoV-2 Neutralizing Titers at 1 Month after dose 3 in Participants 6 Months to <2 Years of age to those at 1 month after Dose 3 in participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	252
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric mean ratio
Point estimate	1.19
Confidence interval
level	95%
sides	2-sided
lower limit	1
upper limit	1.42

Primary: Phase 2/3:GMR for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged 6 Months to 2 Years to Those at 1 Month After Dose 3 in Participants Aged 16 to 25 Years From Phase 2/3 of C4591001:Participants Without Evidence of Infection Top of page

Primary: Phase 2/3:Difference in Percentage of Participants With Seroresponse in 6 Months to <2 Years (1 Month After Dose 3) Compared With Study C4591001 Phase 2/3 16 Through 25 Years (1 Month After Dose 2): Participants Without Evidence of Infection Top of page
End point title	Phase 2/3:Difference in Percentage of Participants With Seroresponse in 6 Months to <2 Years (1 Month After Dose 3) Compared With Study C4591001 Phase 2/3 16 Through 25 Years (1 Month After Dose 2): Participants Without Evidence of Infection
End point description	Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse.Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint. Percentage of participants with seroresponse is reported in descriptive analysis and the difference in percentage of participants is reported under statistical analysis.
End point type	Primary
End point timeframe	C4591007 (>=6 months to <2 years):1 month after Dose 3 and C4591001 control arm (16-25 years):1 month after Dose 2
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years Number of subjects analysed 80 170 Units: Percentage of participants     number (confidence interval 95%) 100.0 (95.5 to 100.0) 98.8 (95.8 to 99.9)
Statistical analysis title	Difference in Percentages
Statistical analysis description	Phase 2/3: Difference in Percentages of Participants With Seroresponse – Participants Without Evidence of Infection – Immunobridging Subset – Comparison of Study C4591007 Phase 2/3 6 Months to <2 Years of Age (1 Month After Dose 3) and Study C4591001 Phase 2/3 16 Through 25 Years of Age (1 Month After Dose 2) – Evaluable Immunogenicity Population
Comparison groups	Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age v Historical cohort:C4591001 BNT162b2(30 mcg)16 Through 25 Years
Number of subjects included in analysis	250
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Difference in percentage
Point estimate	1.2
Confidence interval
level	95%
sides	2-sided
lower limit	-3.4
upper limit	4.2

Primary: Phase 2/3:Difference in Percentage of Participants With Seroresponse in 6 Months to <2 Years (1 Month After Dose 3) Compared With Study C4591001 Phase 2/3 16 Through 25 Years (1 Month After Dose 2): Participants Without Evidence of Infection Top of page

Secondary: Phase 1: GMTs of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=2 to <5 Years of age: Participants Without Evidence of Infection Top of page
End point title	Phase 1: GMTs of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=2 to <5 Years of age: Participants Without Evidence of Infection
End point description	GMT of SARS-CoV-2 neutralizing titers after the study vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs(based on Student's t distribution).Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.Participants without evidence of prior infection were included in the analysis.'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Day 7 post Dose 2
End point values Phase 1: BNT162b2 (3 mcg): 2 to <5 years of age Phase 1: BNT162b2 (10 mcg): 2 to <5 years of age Number of subjects analysed 13 29 Units: Titers     geometric mean (confidence interval 95%) 1350.4 (973.1 to 1873.9) 2059.5 (1679.1 to 2526.0)
No statistical analyses for this end point

Secondary: Phase 1: GMTs of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=2 to <5 Years of age: Participants Without Evidence of Infection Top of page

Secondary: Phase 1: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=6 Months to <2 Years of age: Participants Without Evidence of Infection Top of page
End point title	Phase 1: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=6 Months to <2 Years of age: Participants Without Evidence of Infection
End point description	GMT of SARS-CoV-2 neutralizing titers after the study vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs(based on Student's t distribution).Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.Participants without evidence of prior infection were included in the analysis.'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Day 7 post Dose 2
End point values Phase 1: BNT162b2 (3 mcg): 6 Months to < 2 years of age Number of subjects analysed 13 Units: Titers     geometric mean (confidence interval 95%) 1643.8 (1151.3 to 2347.1)
No statistical analyses for this end point

Secondary: Phase 1: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=6 Months to <2 Years of age: Participants Without Evidence of Infection Top of page

Secondary: Phase 1: GMTs of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=5 to <12 Years of age: Participants Without Evidence of Infection Top of page
End point title	Phase 1: GMTs of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=5 to <12 Years of age: Participants Without Evidence of Infection
End point description	GMT of SARS-CoV-2 neutralizing titers after the study vaccination was reported in this endpoint. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs(based on Student's t distribution).Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.Participants without evidence of prior infection were included in the analysis.'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Day 7 post Dose 2
End point values Phase 1: BNT162b2 (10 mcg): 5 to <12 years of age Phase 1: BNT162b2 (20 mcg): 5 to <12 years of age Number of subjects analysed 15 15 Units: Titers     geometric mean (confidence interval 95%) 4162.6 (2584.7 to 6704.0) 4583.4 (2802.9 to 7494.8)
No statistical analyses for this end point

Secondary: Phase 1: GMTs of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers at 7 Days After Dose 2: >=5 to <12 Years of age: Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: Geometric Mean Titers – NT50: Immunogenicity Set – 5 to <12 Years of Age: Dose 1 to 1 Month After Dose 2:Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Geometric Mean Titers – NT50: Immunogenicity Set – 5 to <12 Years of Age: Dose 1 to 1 Month After Dose 2:Participants Without Evidence of Infection
End point description	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Pre-dose 1 and 1 month after Dose 2
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 264 130 Units: Titers geometric mean (confidence interval 95%)     Pre-dose 1 10.1 (9.9 to 10.3) 10.0 (10.0 to 10.0)     1 month after Dose 2 1197.6 (1106.1 to 1296.6) 10.7 (9.7 to 11.8)
No statistical analyses for this end point

Secondary: Phase 2/3: Geometric Mean Titers – NT50: Immunogenicity Set – 5 to <12 Years of Age: Dose 1 to 1 Month After Dose 2:Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: Geometric Mean Titers – NT50: Immunogenicity Set – 5 to <12 Years of Age:Dose 3 and 1 Month After Dose 3 :Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Geometric Mean Titers – NT50: Immunogenicity Set – 5 to <12 Years of Age:Dose 3 and 1 Month After Dose 3 :Participants Without Evidence of Infection
End point description	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Dose 3 set: Pre-dose 3 and 1 month after Dose 3
End point values Phase 2/3: BNT162b2 (10 mcg) 3-Dose Set Number of subjects analysed 67 Units: Titers number (confidence interval 95%)     Pre-dose 3 271.0 (229.1 to 320.6)     1 month after dose 3 2720.9 (2280.1 to 3247.0)
No statistical analyses for this end point

Secondary: Phase 2/3: Geometric Mean Titers – NT50: Immunogenicity Set – 5 to <12 Years of Age:Dose 3 and 1 Month After Dose 3 :Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: Geometric Mean Titers – NT50:2 to <5 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Geometric Mean Titers – NT50:2 to <5 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection
End point description	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 *LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. 'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 143 59 Units: Titers number (confidence interval 95%)     Pre-dose 1 (n=141, 57) 20.7 (20.3 to 21.2) 20.5 (20.5 to 20.5)     Pre-dose 3 (n=143, 59) 401.1 (361.7 to 444.7) 20.9 (20.1 to 21.8)     1 month after dose 3 (n=143, 59) 1535.2 (1388.2 to 1697.8) 22.9 (19.5 to 26.8)
No statistical analyses for this end point

Secondary: Phase 2/3: Geometric Mean Titers – NT50:2 to <5 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: Geometric Mean Titers- NT50:6 Months to <2 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Geometric Mean Titers- NT50:6 Months to <2 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection
End point description	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. 'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 82 49 Units: Titer number (confidence interval 95%)     Pre- dose 1 (80, 48) 20.8 (20.2 to 21.5) 20.5 (20.5 to 20.5)     Pre-dose 3 (81, 49) 317.0 (268.8 to 373.9) 24.2 (19.7 to 29.8)     1 Month After Dose 3 (82, 49) 1406.5 (1211.3 to 1633.1) 22.3 (18.8 to 26.4)
No statistical analyses for this end point

Secondary: Phase 2/3: Geometric Mean Titers- NT50:6 Months to <2 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Dose 1 to 1 Month After Dose 2: >=5 to 12 Years of age: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Dose 1 to 1 Month After Dose 2: >=5 to 12 Years of age: Participants Without Evidence of Infection
End point description	GMFR of SARS-CoV-2 neutralizing titers from dose 1 to 1 month after dose 2 were reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Assay results below the LLOQ were set to 0.5* LLOQ in the analysis. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	From Dose 1 to 1 month after Dose 2
End point values Phase 2/3: BNT162b2 (10 mcg): 5 to <12 years of age Phase 2/3: Placebo: 5 to <12 years of age Number of subjects analysed 264 130 Units: Fold rise     geometric mean (confidence interval 95%) 118.2 (109.2 to 127.9) 1.1 (1.0 to 1.2)
No statistical analyses for this end point

Secondary: Phase 2/3: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Dose 1 to 1 Month After Dose 2: >=5 to 12 Years of age: Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Each Subsequent Time Point After Dose 3: >=2 to 5 Years of age: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Each Subsequent Time Point After Dose 3: >=2 to 5 Years of age: Participants Without Evidence of Infection
End point description	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs(based on the Student t distribution). Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 infection.Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised,had a valid and determinate immunogenicity result within 28-42 days after the study vaccination,and had no other important protocol deviations as determined by the clinician.'N'=participants evaluable in this endpoint.
End point type	Secondary
End point timeframe	Pre-dose 3, 1 Month After Dose 3
End point values Phase 2/3: BNT162b2 (3 mcg): 2 to <5 years of age Phase 2/3: Placebo: 2 to <5 years of age Number of subjects analysed 141 57 Units: Fold rise geometric mean (confidence interval 95%)     Pre-dose 3 19.2 (17.4 to 21.3) 1.0 (1.0 to 1.0)     1 month after Dose 3 73.3 (66.3 to 81.1) 1.1 (0.9 to 1.3)
No statistical analyses for this end point

Secondary: Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Each Subsequent Time Point After Dose 3: >=2 to 5 Years of age: Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3:GMFR of SARS-CoV-2 Neutralizing Titers From Dose 3 to 1 Month After Dose 3: >=5 to 12 Years of age: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3:GMFR of SARS-CoV-2 Neutralizing Titers From Dose 3 to 1 Month After Dose 3: >=5 to 12 Years of age: Participants Without Evidence of Infection
End point description	GMFR of SARS-CoV-2 neutralizing titers from before Dose 3 to 1 month after Dose were reported in this endpoint. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomized participants who received the study interventions to which they were randomized, had a valid and determined immunogenicity result within 28-42 days after Dose 3, and had no other important protocol deviations as determined by the clinicians. 'N' = participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Before dose 1 to 1 month after dose 2, pre-dose 3 and 1 month after dose 3
End point values Phase 2/3: BNT162b2 (10 mcg) 3-Dose Set Number of subjects analysed 67 Units: Fold rise     geometric mean (confidence interval 95%) 10.0 (8.1 to 12.4)
No statistical analyses for this end point

Secondary: Phase 2/3:GMFR of SARS-CoV-2 Neutralizing Titers From Dose 3 to 1 Month After Dose 3: >=5 to 12 Years of age: Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Each Subsequent Time Point After Dose 3: >=6 Months to 2 Years of age: Participants Without Evidence of Infection Top of page
End point title	Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Each Subsequent Time Point After Dose 3: >=6 Months to 2 Years of age: Participants Without Evidence of Infection
End point description	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection prior to the 1-month post–Dose 2. Evaluable immunogenicity population included all eligible randomised participants who received the study intervention to which they were randomised, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician. 'N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	Pre-dose 3, 1 Month After Dose 3
End point values Phase 2/3: BNT162b2 (3 mcg): 6 months to <2 years of age Phase 2/3: Placebo: 6 months to <2 years Number of subjects analysed 80 48 Units: Fold rise geometric mean (confidence interval 95%)     Pre-dose 3 (79,48) 15.4 (12.9 to 18.3) 1.2 (1.0 to 1.5)     1 month after Dose 3 (80,48) 68.4 (58.2 to 80.4) 1.1 (0.9 to 1.3)
No statistical analyses for this end point

Secondary: Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Each Subsequent Time Point After Dose 3: >=6 Months to 2 Years of age: Participants Without Evidence of Infection Top of page

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 2 to Prior to Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 2 to Prior to Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=5 to <12 Years of age
End point description	Number of confirmed COVID-19 cases from 7 days after dose 2 to prior to dose 3 without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2.
End point type	Secondary
End point timeframe	From 7 days after Dose 2 to prior to dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.591; Placebo - 0.292)
End point values Ph2/3:BNT162b2 3 mcg 5-<12Y:WoEI:evaluable efficacy(3-dose)set Phase 2/3:Placebo 5 to <12Y:WoEI:evaluable efficacy(3-dose)set Number of subjects analysed 2703 1348 Units: Cases     number (not applicable) 10 42
No statistical analyses for this end point

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 2 to Prior to Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=5 to <12 Years of age Top of page

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=6 Months to <5 Years of Age Top of page
End point title	Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=6 Months to <5 Years of Age
End point description	Number of confirmed COVID-19 cases from 7 days after dose 3 without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 3 received within the predefined window (within 19-42 days after Dose 2) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2. N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.124; Placebo - 0.054)
End point values Ph2/3:BNT162b2 3mcg:6M-<5Y:WoEI:evaluable efficacy(3dose)set Phase2/3:Placebo:6M-<5Y):WoEI:evaluable efficacy(3-dose)set Number of subjects analysed 873 381 Units: Cases     number (not applicable) 13 21
No statistical analyses for this end point

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=6 Months to <5 Years of Age Top of page

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 2 to prior to Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=5 to <12 Years of age Top of page
End point title	Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 2 to prior to Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=5 to <12 Years of age
End point description	Number of confirmed COVID-19 cases from 7 days after dose 2 to prior to dose 3 with or without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2.
End point type	Secondary
End point timeframe	From 7 Days After Dose 2 to prior to dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.653; Placebo - 0.326)
End point values Phase 2/3:BNT162b2 3 mcg 5-<12Y:evaluable efficacy(3-dose)set Phase 2/3:Placebo 5-<12Y:evaluable efficacy(3-dose)set Number of subjects analysed 3108 1511 Units: Cases     number (not applicable) 12 42
No statistical analyses for this end point

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 2 to prior to Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=5 to <12 Years of age Top of page

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=6 Months to <5 Years of age Top of page
End point title	Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=6 Months to <5 Years of age
End point description	Number of confirmed COVID-19 cases from 7 days after dose 3 without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 3 received within the predefined window (within 19-42 days after Dose 2) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2. N'=participants evaluable for this endpoint.
End point type	Secondary
End point timeframe	From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.149; Placebo - 0.067)
End point values Phase 2/3:BNT162b2 3 mcg 6M<5Y:evaluable efficacy(3-dose)set Phase 2/3:Placebo 6M-<5Y:evaluable efficacy(3-dose)set Number of subjects analysed 1294 612 Units: Cases     number (not applicable) 14 23
No statistical analyses for this end point

Secondary: Phase 2/3: Confirmed COVID-19 Cases From 7 Days After Dose 3 per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=6 Months to <5 Years of age Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Local/systemic events: Day 1 to 7 after each dose. Non SAE: Treatment emergent adverse events are reported from time of first dose of study treatment up to 1 month after last dose. SAE: From first dose to 6 months after last dose of study treatment
Adverse event reporting additional description	Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE.
Assessment type	Non-systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	26.1
Reporting groups
Reporting group title	Ph2/3:BlPCFup:6M-<2Y:D1-6M After D2or Prior D3/BNT162b2 3mcg
Reporting group description	Phase 2/3: Participants aged 6 months to <2 years were randomised to receive dose 1 of BNT162b2 3 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period were followed up to 6 month after dose 2 or prior to dose 3.
Reporting group title	Ph2/3:Bl PCFup:6 M -<2Y:D1-1M After D2/BNT162b2 3 mcg‌
Reporting group description	Phase 2/3 (Ph2/3): Participants aged 6 months to <2 years (6 M -<2 Yrs) were randomised to receive dose 1 (D1) of BNT162b2 3 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period (Bl PCFup) and were followed up to 1 month after dose 2 (1M After D2).
Reporting group title	Ph2/3:Bl PCFup:6 M-<2Y:D1-1M After D2/Pb
Reporting group description	Phase 2/3: Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo)(Pb) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 2.
Reporting group title	Ph2/3:Bl PCFup:6M-<2Y:D3-6M After D3/Pb
Reporting group description	Phase 2/3:Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 6 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:6M-<2Y:D3-6M After D3/BNT162b2 3mcg
Reporting group description	Phase 2/3: Participants aged 6 months to <2 years were randomised to receive dose 3 of BNT162b2 3 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 6 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:6M-<2Y:D3-1M After D3/Pb
Reporting group description	Phase 2/3:Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:6M-<2Y:D3-1M After D3/BNT162b2 3mcg
Reporting group description	Phase 2/3: Participants aged 6 months to <2 years were randomised to receive dose 3 of BNT162b2 3 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:BlPCFup:6M-<2Y:D1-6M After D2 or Prior D3/Pb
Reporting group description	Phase 2/3: Participants aged 6 months to <2 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 6 month after dose 2 or prior to dose 3.
Reporting group title	Ph2/3:Bl PCFup:5-<12Y:D1-1M After D2/ BNT162b2 10mcg
Reporting group description	Phase 2/3:Participants aged 5 to <12 years were randomised to receive dose 1 of BNT162b2 10 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 2.
Reporting group title	Ph2/3:Bl PCFup:5-<12Y:TPG:D1-6M After D2/BNT162b2 10 mcg
Reporting group description	Phase 2/3: Participants aged 5 to <12 years were randomised to receive dose 1 of BNT162b2 10 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period in Troponin group and were followed up to 6 month after dose 2.
Reporting group title	Ph2/3:BlPCFup:5-<12Y:TPG:D1-6MAfterD2 orPriorD3/BNT162b210mcg
Reporting group description	Phase 2/3: Participants aged 5 to <12 years were randomised to receive dose 1 of BNT162b2 10 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period in Troponin group (TPG) and were followed up to 6 month after dose 2 or prior to dose 3.
Reporting group title	Ph2/3:Bl PCFup:2-<5Y:D3-6M After D3/Pb
Reporting group description	Phase 2/3: Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 6 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:2-<5Y:D3-6M After D3/BNT162b2 3mcg
Reporting group description	Phase 2/3: Participants aged 2 to <5 years were randomised to receive dose 3 of BNT162b2 3 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 6 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:2-<5Y:D3-1M After D3/Pb
Reporting group description	Phase 2/3:Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:2-<5Y:D3-1M After D3/BNT162b2 3mcg
Reporting group description	Phase 2/3: Participants aged 2 to <5 years were randomised to receive dose 3 of BNT162b2 3 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:BlPCFup:2-<5Y:D1-6M After D2 or Prior D3/Pb
Reporting group description	Phase 2/3:Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 6 month after dose 2 or Prior to Dose 3.
Reporting group title	Ph2/3:BlPCFup:2-<5Y:D1-6M After D2 or Prior D3/BNT162b2 3mcg
Reporting group description	Phase 2/3:Participants aged 2 to <5 years were randomised to receive dose 1 of BNT162b2 3 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 6 month after dose 2 or Prior to Dose 3.
Reporting group title	Ph2/3:Bl PCFup:5-<12Y:TPG:D1-6M After D2 or Prior D3/Pb
Reporting group description	Phase 2/3: Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period in Troponin group and were followed up to 6 month after dose 2 or prior to dose 3.
Reporting group title	Ph2/3:BlPCFup:2-<5Y:D1-1M After D2/ BNT162b2 3mcg
Reporting group description	Phase 2/3:Participants aged 2 to <5 years were randomised to receive dose 3 of BNT162b2 3 mcg intramuscularly in blinded placebo-controlled follow up period and were followed up from dose 1 to 1 month after dose 2.
Reporting group title	Ph2/3:Bl PCFup:2-<5Y:D1-1M After D2/Pb
Reporting group description	Phase 2/3:Participants aged 2 to <5 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in blinded placebo controlled follow up period and were followed from Dose 1 to 1 month after dose 2.
Reporting group title	Ph2/3:5-<12Y:TPG:D3-1M After D3/BNT162b2 10 mcg
Reporting group description	Phase 2/3: Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) intramuscularly in Blinded Placebo and had the opportunity to receive dose 3 as BNT162b2 10 mcg in Open Label Period in Troponin group and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:5-<12Y:TPG:D3-1M After D3/BNT162b2 10 mcg
Reporting group description	Phase 2/3: Participants aged 5 to <12 years were randomised to receive dose 3 of BNT162b2 10 mcg intramuscularly in Blinded and Open Label Period (OLP) in Troponin group and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:Bl OLP:5-<12Y:TPG:D3-6M After D3/BNT162b2 10 mcg
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) intramuscularly in Blinded Placebo and had the opportunity to receive dose 3 as BNT162b2 10 mcg in Open Label Period in Troponin group and were followed up to 6 month after dose 3.
Reporting group title	Ph1:2-<5Y:D1-1M After D2/BNT162b2 3 mcg
Reporting group description	Phase 1: Participants aged 2 to <5 years received dose 1 of BNT162b2 3 mcg intramuscularly and were followed up to 1 month after dose 2.
Reporting group title	Ph1:6M-<2Y:D3-1M After D3/BNT162b2 3 mcg
Reporting group description	Phase 1: Participants aged 6 months to <2 years received dose 3 of BNT162b2 3 mcg intramuscularly and were followed up to 1 month after dose 3.
Reporting group title	Ph1:6M-<2Y:D1-6M After D2/BNT162b2 3 mcg
Reporting group description	Phase 1: Participants aged 6 months to <2 years received dose 1 of BNT162b2 3 mcg intramuscularly and were followed up to 6 month after dose 2.
Reporting group title	Ph2/3:OLP:12-<16Y:TPG:D3-1M After D3/BNT162b2 30 mcg
Reporting group description	Phase 2/3: Participants aged 12 to <16 years were randomised to receive dose 3 of BNT162b2 30 mcg intramuscularly in open label in Troponin group and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:OLP:12-<16Y:TPG:D1-6M After D2or priorD3/BNT162b2 30mcg
Reporting group description	Phase 2/3: Participants aged 12 to <16 years were randomised to receive dose 1 of BNT162b2 30 mcg intramuscularly in open label in Troponin group and were followed up to 6 month after dose 2 or prior to dose 3.
Reporting group title	Ph2/3:OLP:12-<16Y:TPG:D1-1M After D2/BNT162b2 30 mcg
Reporting group description	Phase 2/3: Participants aged 12 to <16 years were randomised to receive dose 1 of BNT162b2 30 mcg intramuscularly in Open label in Troponin group and were followed up to 1 month after dose 2.
Reporting group title	Ph1:2-<5Y:D1-1M After D2/BNT162b2 10 mcg
Reporting group description	Phase 1: Participants aged 2 to <5 years received dose 1 of BNT162b2 10 mcg intramuscularly and were followed up to 1 month after dose 2.
Reporting group title	Ph1:2-<5Y:D3-1M After D3/BNT162b2 3 mcg
Reporting group description	Phase 1: Participants aged 2 to <5 years received dose 3 of BNT162b2 3 mcg intramuscularly and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:BlPCFup:5 -<12Y:D1-1M After D2 or PTD3/Pb
Reporting group description	Phase 2/3:Participants aged 5 to <12 years received 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 2 or prior to dose 3.
Reporting group title	Ph2/3:BlOLP:5-<12Y:D3-1M After D3/BNT162b2 10 mcg
Reporting group description	Participants aged 5 to <12 years were randomised to receive dose 3 as BNT162b2 10 mcg in Blinded and Open Label Period and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:BlOLP:5-<12Y:D3-1M After D3/BNT162b2 10 mcg
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) intramuscularly in Blinded Placebo and had the opportunity to receive dose 3 as BNT162b2 10 mcg in Open Label Period in Troponin group and were followed up to 1 month after dose 3.
Reporting group title	Ph1:5-<12Y:D1-6M After D2/BNT162b2 10 mcg
Reporting group description	Phase 1: Participants aged 5 to <12 years received dose 1 of BNT162b2 10 mcg intramuscularly and were followed up to 6 month after dose 2.
Reporting group title	Ph1:5-<12Y:D1-6M After D2/BNT162b2 10 mcg
Reporting group description	Phase 1: Participants aged 5 to <12 years received dose 1 of BNT162b2 10 mcg intramuscularly and were followed up to 6 month after dose 2.
Reporting group title	Ph1:5-<12Y:D1-1M After D2/BNT162b2 (30/30 mcg)
Reporting group description	Phase 1: Participants aged 5 to <12 years of age received dose 1 of 30 mcg BNT162b2 and received third dose of 10 mcg BNT162b2 were followed up to 1 month after dose 2.
Reporting group title	Ph1:5-<12Y:D1-1M After D2/BNT162b2 (30/10 mcg)
Reporting group description	Phase 1: Participants aged 5 to <12 years of age received dose 1 of 30 mcg, followed by dose 2 of 10 mcg BNT162b2 and received third dose of 10 mcg BNT162b2 were followed up to 1 month after dose 2.
Reporting group title	Ph1:5-<12Y:D3-1M After D3/BNT162b2 10 mcg
Reporting group description	Phase 1: Participants aged 5 to <12 years received dose 3 of BNT162b2 10 mcg intramuscularly and were followed up to 1 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:6M-<2Y:D1-1M After D2/Placebo
Reporting group description	Phase 2/3:Participants aged 6 months to <2 years were received 0.9% sodium chloride solution for Injection intramuscularly (Placebo) in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 2.
Reporting group title	Ph2/3:BlPCFup:5 -<12Y:D1-1M After D2 or PTD3/BNT162b2 10 mcg
Reporting group description	Phase 2/3:Participants aged 5 to <12 years received dose 1 of BNT162b2 10 mcg intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 2 or prior to dose 3.
Reporting group title	Ph2/3:Bl OLP:5-<12Y:D3-6M After D3/Org BNT162b2 10 mcg
Reporting group description	Participants aged 5 to <12 years received dose 3 as Original (Org) BNT162b2 10 mcg in Blinded and Open Label Period were followed up to 6 month after dose 3.
Reporting group title	Ph2/3:Bl PCFup:5-<12Y:TPG:D1-1M After D2/Pb BNT162b2 10 mcg
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) intramuscularly in Blinded Placebo-Controlled Follow-Up Period and were followed up to 1 month after dose 2.
Reporting group title	Ph2/3:Bl OLP:5-<12Y:D3-6M After D3/BNT162b2 10 mcg
Reporting group description	Participants aged 5 to <12 years were randomised to receive dose 3 as BNT162b2 10 mcg in Blinded and Open Label Period and were followed up to 6 month after dose 3.
Reporting group title	Ph2/3:Bl OLP:5-<12Y:TPG:D3-1M After D3/Org BNT162b2 10 mcg
Reporting group description	Participants aged 5 to <12 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly (Placebo) intramuscularly in Blinded and Open Label period and had the opportunity to receive dose 3 as BNT162b2 10 mcg in Open Label Period in Troponin group and were followed up to 6 month after dose 3.
Serious adverse events Ph2/3:BlPCFup:6M-<2Y:D1-6M After D2or Prior D3/BNT162b2 3mcg Ph2/3:Bl PCFup:6 M -<2Y:D1-1M After D2/BNT162b2 3 mcg‌ Ph2/3:Bl PCFup:6 M-<2Y:D1-1M After D2/Pb Ph2/3:Bl PCFup:6M-<2Y:D3-6M After D3/Pb Ph2/3:Bl PCFup:6M-<2Y:D3-6M After D3/BNT162b2 3mcg Ph2/3:Bl PCFup:6M-<2Y:D3-1M After D3/Pb Ph2/3:Bl PCFup:6M-<2Y:D3-1M After D3/BNT162b2 3mcg Ph2/3:BlPCFup:6M-<2Y:D1-6M After D2 or Prior D3/Pb Ph2/3:Bl PCFup:5-<12Y:D1-1M After D2/ BNT162b2 10mcg Ph2/3:Bl PCFup:5-<12Y:TPG:D1-6M After D2/BNT162b2 10 mcg Ph2/3:BlPCFup:5-<12Y:TPG:D1-6MAfterD2 orPriorD3/BNT162b210mcg Ph2/3:Bl PCFup:2-<5Y:D3-6M After D3/Pb Ph2/3:Bl PCFup:2-<5Y:D3-6M After D3/BNT162b2 3mcg Ph2/3:Bl PCFup:2-<5Y:D3-1M After D3/Pb Ph2/3:Bl PCFup:2-<5Y:D3-1M After D3/BNT162b2 3mcg Ph2/3:BlPCFup:2-<5Y:D1-6M After D2 or Prior D3/Pb Ph2/3:BlPCFup:2-<5Y:D1-6M After D2 or Prior D3/BNT162b2 3mcg Ph2/3:Bl PCFup:5-<12Y:TPG:D1-6M After D2 or Prior D3/Pb Ph2/3:BlPCFup:2-<5Y:D1-1M After D2/ BNT162b2 3mcg Ph2/3:Bl PCFup:2-<5Y:D1-1M After D2/Pb Ph2/3:5-<12Y:TPG:D3-1M After D3/BNT162b2 10 mcg Ph2/3:5-<12Y:TPG:D3-1M After D3/BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:TPG:D3-6M After D3/BNT162b2 10 mcg Ph1:2-<5Y:D1-1M After D2/BNT162b2 3 mcg Ph1:6M-<2Y:D3-1M After D3/BNT162b2 3 mcg Ph1:6M-<2Y:D1-6M After D2/BNT162b2 3 mcg Ph2/3:OLP:12-<16Y:TPG:D3-1M After D3/BNT162b2 30 mcg Ph2/3:OLP:12-<16Y:TPG:D1-6M After D2or priorD3/BNT162b2 30mcg Ph2/3:OLP:12-<16Y:TPG:D1-1M After D2/BNT162b2 30 mcg Ph1:2-<5Y:D1-1M After D2/BNT162b2 10 mcg Ph1:2-<5Y:D3-1M After D3/BNT162b2 3 mcg Ph2/3:BlPCFup:5 -<12Y:D1-1M After D2 or PTD3/Pb Ph2/3:BlOLP:5-<12Y:D3-1M After D3/BNT162b2 10 mcg Ph2/3:BlOLP:5-<12Y:D3-1M After D3/BNT162b2 10 mcg Ph1:5-<12Y:D1-6M After D2/BNT162b2 10 mcg Ph1:5-<12Y:D1-6M After D2/BNT162b2 10 mcg Ph1:5-<12Y:D1-1M After D2/BNT162b2 (30/30 mcg) Ph1:5-<12Y:D1-1M After D2/BNT162b2 (30/10 mcg) Ph1:5-<12Y:D3-1M After D3/BNT162b2 10 mcg Ph2/3:Bl PCFup:6M-<2Y:D1-1M After D2/Placebo Ph2/3:BlPCFup:5 -<12Y:D1-1M After D2 or PTD3/BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:D3-6M After D3/Org BNT162b2 10 mcg Ph2/3:Bl PCFup:5-<12Y:TPG:D1-1M After D2/Pb BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:D3-6M After D3/BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:TPG:D3-1M After D3/Org BNT162b2 10 mcg Total subjects affected by serious adverse events      subjects affected / exposed 24 / 1458 (1.65%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 1 / 483 (0.21%) 0 / 237 (0.00%) 0 / 483 (0.00%) 17 / 718 (2.37%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 1 / 518 (0.19%) 0 / 405 (0.00%) 3 / 863 (0.35%) 0 / 405 (0.00%) 0 / 863 (0.00%) 10 / 1173 (0.85%) 11 / 2368 (0.46%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 2 / 418 (0.48%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 2 / 487 (0.41%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 3 / 1538 (0.20%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 8 / 3109 (0.26%) 3 / 957 (0.31%) 0 / 260 (0.00%) 10 / 2410 (0.41%) 0 / 202 (0.00%)      number of deaths (all causes) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0      number of deaths resulting from adverse events 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Vascular disorders Cyanosis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 2 / 718 (0.28%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pregnancy, puerperium and perinatal conditions Abortion spontaneous      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 1 / 487 (0.21%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 General disorders and administration site conditions Pyrexia      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Immune system disorders Anaphylactic reaction      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Reproductive system and breast disorders Ovarian cyst      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 1 / 487 (0.21%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Testicular appendage torsion      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory, thoracic and mediastinal disorders Acute respiratory failure      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Asthma      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 1 / 518 (0.19%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 1 / 957 (0.10%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchial hyperreactivity      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumomediastinum      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory arrest      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 1 / 418 (0.24%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory distress      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Psychiatric disorders Disruptive mood dysregulation disorder      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Suicidal ideation      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Injury, poisoning and procedural complications Accidental overdose      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Burns second degree      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Concussion      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Epiphyseal fracture      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Eyelid injury      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Fall      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Femur fracture      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Foreign body      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Foreign body ingestion      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Head injury      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Thermal burn      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Upper limb fracture      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nervous system disorders Epilepsy      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Febrile convulsion      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Narcolepsy      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 1 / 1538 (0.07%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Seizure      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Status epilepticus      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Syncope      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 1 / 957 (0.10%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Transient ischaemic attack      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Blood and lymphatic system disorders Sickle cell anaemia with crisis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 1 / 418 (0.24%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Eye disorders Papilloedema      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal disorders Diarrhoea      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Abdominal pain      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 1 / 1538 (0.07%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Colitis ulcerative      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 1 / 863 (0.12%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Constipation      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intestinal obstruction      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pancreatitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 1 / 1538 (0.07%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Vomiting      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Skin and subcutaneous tissue disorders Dermal cyst      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 1 / 863 (0.12%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Musculoskeletal and connective tissue disorders Pain in extremity      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infections and infestations Abdominal abscess      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 1 / 957 (0.10%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Acute sinusitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Anal abscess      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Appendicitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 2 / 2368 (0.08%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 1 / 957 (0.10%) 0 / 260 (0.00%) 1 / 2410 (0.04%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Arthritis bacterial      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchiolitis      subjects affected / exposed 3 / 1458 (0.21%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 3 / 718 (0.42%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cellulitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Complicated appendicitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 1 / 1538 (0.07%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Enterovirus infection      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Exanthema subitum      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Focal peritonitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis      subjects affected / exposed 3 / 1458 (0.21%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis adenovirus      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis norovirus      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis rotavirus      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis viral      subjects affected / exposed 2 / 1458 (0.14%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 HCoV-NL63 infection      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Large intestine infection      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lower respiratory tract infection      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lower respiratory tract infection viral      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metapneumovirus infection      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Otitis media      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Otitis media acute      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Parainfluenzae virus infection      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia      subjects affected / exposed 2 / 1458 (0.14%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 1 / 863 (0.12%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia respiratory syncytial viral      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 1 / 3109 (0.03%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory syncytial virus bronchiolitis      subjects affected / exposed 5 / 1458 (0.34%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 1 / 483 (0.21%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 6 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory syncytial virus infection      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Rhinovirus infection      subjects affected / exposed 1 / 1458 (0.07%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 1 / 1173 (0.09%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Tonsillitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Upper respiratory tract infection      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 1 / 2368 (0.04%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Viral infection      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metabolism and nutrition disorders Dehydration      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 2 / 2368 (0.08%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Feeding intolerance      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypoglycaemia      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 1 / 718 (0.14%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 1%
Non-serious adverse events Ph2/3:BlPCFup:6M-<2Y:D1-6M After D2or Prior D3/BNT162b2 3mcg Ph2/3:Bl PCFup:6 M -<2Y:D1-1M After D2/BNT162b2 3 mcg‌ Ph2/3:Bl PCFup:6 M-<2Y:D1-1M After D2/Pb Ph2/3:Bl PCFup:6M-<2Y:D3-6M After D3/Pb Ph2/3:Bl PCFup:6M-<2Y:D3-6M After D3/BNT162b2 3mcg Ph2/3:Bl PCFup:6M-<2Y:D3-1M After D3/Pb Ph2/3:Bl PCFup:6M-<2Y:D3-1M After D3/BNT162b2 3mcg Ph2/3:BlPCFup:6M-<2Y:D1-6M After D2 or Prior D3/Pb Ph2/3:Bl PCFup:5-<12Y:D1-1M After D2/ BNT162b2 10mcg Ph2/3:Bl PCFup:5-<12Y:TPG:D1-6M After D2/BNT162b2 10 mcg Ph2/3:BlPCFup:5-<12Y:TPG:D1-6MAfterD2 orPriorD3/BNT162b210mcg Ph2/3:Bl PCFup:2-<5Y:D3-6M After D3/Pb Ph2/3:Bl PCFup:2-<5Y:D3-6M After D3/BNT162b2 3mcg Ph2/3:Bl PCFup:2-<5Y:D3-1M After D3/Pb Ph2/3:Bl PCFup:2-<5Y:D3-1M After D3/BNT162b2 3mcg Ph2/3:BlPCFup:2-<5Y:D1-6M After D2 or Prior D3/Pb Ph2/3:BlPCFup:2-<5Y:D1-6M After D2 or Prior D3/BNT162b2 3mcg Ph2/3:Bl PCFup:5-<12Y:TPG:D1-6M After D2 or Prior D3/Pb Ph2/3:BlPCFup:2-<5Y:D1-1M After D2/ BNT162b2 3mcg Ph2/3:Bl PCFup:2-<5Y:D1-1M After D2/Pb Ph2/3:5-<12Y:TPG:D3-1M After D3/BNT162b2 10 mcg Ph2/3:5-<12Y:TPG:D3-1M After D3/BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:TPG:D3-6M After D3/BNT162b2 10 mcg Ph1:2-<5Y:D1-1M After D2/BNT162b2 3 mcg Ph1:6M-<2Y:D3-1M After D3/BNT162b2 3 mcg Ph1:6M-<2Y:D1-6M After D2/BNT162b2 3 mcg Ph2/3:OLP:12-<16Y:TPG:D3-1M After D3/BNT162b2 30 mcg Ph2/3:OLP:12-<16Y:TPG:D1-6M After D2or priorD3/BNT162b2 30mcg Ph2/3:OLP:12-<16Y:TPG:D1-1M After D2/BNT162b2 30 mcg Ph1:2-<5Y:D1-1M After D2/BNT162b2 10 mcg Ph1:2-<5Y:D3-1M After D3/BNT162b2 3 mcg Ph2/3:BlPCFup:5 -<12Y:D1-1M After D2 or PTD3/Pb Ph2/3:BlOLP:5-<12Y:D3-1M After D3/BNT162b2 10 mcg Ph2/3:BlOLP:5-<12Y:D3-1M After D3/BNT162b2 10 mcg Ph1:5-<12Y:D1-6M After D2/BNT162b2 10 mcg Ph1:5-<12Y:D1-6M After D2/BNT162b2 10 mcg Ph1:5-<12Y:D1-1M After D2/BNT162b2 (30/30 mcg) Ph1:5-<12Y:D1-1M After D2/BNT162b2 (30/10 mcg) Ph1:5-<12Y:D3-1M After D3/BNT162b2 10 mcg Ph2/3:Bl PCFup:6M-<2Y:D1-1M After D2/Placebo Ph2/3:BlPCFup:5 -<12Y:D1-1M After D2 or PTD3/BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:D3-6M After D3/Org BNT162b2 10 mcg Ph2/3:Bl PCFup:5-<12Y:TPG:D1-1M After D2/Pb BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:D3-6M After D3/BNT162b2 10 mcg Ph2/3:Bl OLP:5-<12Y:TPG:D3-1M After D3/Org BNT162b2 10 mcg Total subjects affected by non serious adverse events      subjects affected / exposed 0 / 1458 (0.00%) 1154 / 1458 (79.15%) 550 / 718 (76.60%) 0 / 237 (0.00%) 0 / 483 (0.00%) 119 / 237 (50.21%) 267 / 483 (55.28%) 0 / 718 (0.00%) 2821 / 3109 (90.74%) 442 / 518 (85.33%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 152 / 405 (37.53%) 398 / 863 (46.12%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 1661 / 2368 (70.14%) 778 / 1173 (66.33%) 22 / 202 (10.89%) 319 / 418 (76.32%) 0 / 418 (0.00%) 10 / 16 (62.50%) 7 / 15 (46.67%) 10 / 16 (62.50%) 285 / 433 (65.82%) 0 / 487 (0.00%) 414 / 487 (85.01%) 32 / 32 (100.00%) 17 / 27 (62.96%) 0 / 1538 (0.00%) 1794 / 2410 (74.44%) 80 / 957 (8.36%) 16 / 16 (100.00%) 16 / 16 (100.00%) 4 / 4 (100.00%) 11 / 12 (91.67%) 35 / 38 (92.11%) 1083 / 1538 (70.42%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 163 / 260 (62.69%) 0 / 2410 (0.00%) 0 / 202 (0.00%) General disorders and administration site conditions Axillary pain      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 5 / 418 (1.20%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Chills (CHILLS) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 413 / 3109 (13.28%) 50 / 518 (9.65%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 10 / 405 (2.47%) 22 / 863 (2.55%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 125 / 2368 (5.28%) 59 / 1173 (5.03%) 0 / 202 (0.00%) 35 / 418 (8.37%) 0 / 418 (0.00%) 1 / 16 (6.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 52 / 433 (12.01%) 0 / 487 (0.00%) 88 / 487 (18.07%) 3 / 32 (9.38%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 231 / 2410 (9.59%) 0 / 957 (0.00%) 5 / 16 (31.25%) 7 / 16 (43.75%) 3 / 4 (75.00%) 5 / 12 (41.67%) 6 / 38 (15.79%) 129 / 1538 (8.39%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 31 / 260 (11.92%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 475 54 0 0 0 10 22 0 0 0 129 63 0 35 0 2 0 0 52 0 104 4 0 0 231 0 5 11 5 6 6 150 0 0 33 0 0 Fatigue      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 3 / 202 (1.49%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 14 / 2410 (0.58%) 16 / 957 (1.67%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 14 16 0 0 0 0 1 0 0 0 0 0 0 Fatigue (FATIGUE) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 1614 / 3109 (51.91%) 221 / 518 (42.66%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 91 / 405 (22.47%) 202 / 863 (23.41%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 977 / 2368 (41.26%) 487 / 1173 (41.52%) 0 / 202 (0.00%) 153 / 418 (36.60%) 0 / 418 (0.00%) 5 / 16 (31.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 149 / 433 (34.41%) 0 / 487 (0.00%) 255 / 487 (52.36%) 23 / 32 (71.88%) 8 / 27 (29.63%) 0 / 1538 (0.00%) 897 / 2410 (37.22%) 0 / 957 (0.00%) 14 / 16 (87.50%) 13 / 16 (81.25%) 4 / 4 (100.00%) 10 / 12 (83.33%) 15 / 38 (39.47%) 641 / 1538 (41.68%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 105 / 260 (40.38%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 2267 256 0 0 0 91 202 0 0 0 1247 622 0 153 0 8 0 0 149 0 364 34 8 0 897 0 19 21 8 15 15 879 0 0 128 0 0 Injection site bruising      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Injection site discomfort      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Injection site erythema      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 1 / 12 (8.33%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 Injection site erythema (REDNESS) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 237 / 1458 (16.26%) 83 / 718 (11.56%) 0 / 237 (0.00%) 0 / 483 (0.00%) 11 / 237 (4.64%) 33 / 483 (6.83%) 0 / 718 (0.00%) 806 / 3109 (25.92%) 92 / 518 (17.76%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 18 / 405 (4.44%) 83 / 863 (9.62%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 379 / 2368 (16.01%) 136 / 1173 (11.59%) 0 / 202 (0.00%) 67 / 418 (16.03%) 0 / 418 (0.00%) 0 / 16 (0.00%) 2 / 15 (13.33%) 3 / 16 (18.75%) 14 / 433 (3.23%) 0 / 487 (0.00%) 12 / 487 (2.46%) 9 / 32 (28.13%) 1 / 27 (3.70%) 0 / 1538 (0.00%) 354 / 2410 (14.69%) 0 / 957 (0.00%) 8 / 16 (50.00%) 3 / 16 (18.75%) 4 / 4 (100.00%) 3 / 12 (25.00%) 11 / 38 (28.95%) 148 / 1538 (9.62%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 17 / 260 (6.54%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 285 96 0 0 11 33 0 1009 107 0 0 0 18 83 0 0 0 444 154 0 67 0 0 2 3 14 0 14 14 1 0 354 0 8 3 7 4 11 170 0 0 18 0 0 Injection site pain      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 17 / 202 (8.42%) 7 / 418 (1.67%) 0 / 418 (0.00%) 2 / 16 (12.50%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 3 / 32 (9.38%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 34 / 2410 (1.41%) 60 / 957 (6.27%) 1 / 16 (6.25%) 1 / 16 (6.25%) 0 / 4 (0.00%) 2 / 12 (16.67%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 18 7 0 2 0 0 0 0 0 3 0 0 34 60 1 1 0 2 1 0 0 0 0 0 0 Injection site pain (PAIN) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 2603 / 3109 (83.72%) 397 / 518 (76.64%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 48 / 405 (11.85%) 222 / 863 (25.72%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 998 / 2368 (42.15%) 357 / 1173 (30.43%) 0 / 202 (0.00%) 273 / 418 (65.31%) 0 / 418 (0.00%) 7 / 16 (43.75%) 0 / 15 (0.00%) 0 / 16 (0.00%) 257 / 433 (59.35%) 0 / 487 (0.00%) 384 / 487 (78.85%) 21 / 32 (65.63%) 9 / 27 (33.33%) 0 / 1538 (0.00%) 1568 / 2410 (65.06%) 0 / 957 (0.00%) 14 / 16 (87.50%) 15 / 16 (93.75%) 4 / 4 (100.00%) 11 / 12 (91.67%) 33 / 38 (86.84%) 661 / 1538 (42.98%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 79 / 260 (30.38%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 4439 522 0 0 0 48 222 0 0 0 1329 449 0 273 0 11 0 0 257 0 603 37 9 0 1568 0 28 27 8 21 33 916 0 0 98 0 0 Injection site pain (TENDERNESS) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 353 / 1458 (24.21%) 126 / 718 (17.55%) 0 / 237 (0.00%) 0 / 483 (0.00%) 22 / 237 (9.28%) 67 / 483 (13.87%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 4 / 15 (26.67%) 1 / 16 (6.25%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 448 151 0 0 22 67 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Injection site swelling (SWELLING) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 94 / 1458 (6.45%) 26 / 718 (3.62%) 0 / 237 (0.00%) 0 / 483 (0.00%) 5 / 237 (2.11%) 15 / 483 (3.11%) 0 / 718 (0.00%) 622 / 3109 (20.01%) 69 / 518 (13.32%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 6 / 405 (1.48%) 25 / 863 (2.90%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 182 / 2368 (7.69%) 53 / 1173 (4.52%) 0 / 202 (0.00%) 50 / 418 (11.96%) 0 / 418 (0.00%) 0 / 16 (0.00%) 1 / 15 (6.67%) 1 / 16 (6.25%) 12 / 433 (2.77%) 0 / 487 (0.00%) 27 / 487 (5.54%) 4 / 32 (12.50%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 286 / 2410 (11.87%) 0 / 957 (0.00%) 8 / 16 (50.00%) 3 / 16 (18.75%) 3 / 4 (75.00%) 1 / 12 (8.33%) 5 / 38 (13.16%) 78 / 1538 (5.07%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 14 / 260 (5.38%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 108 28 0 0 5 15 0 770 77 0 0 0 6 25 0 0 0 209 57 0 50 0 0 1 1 12 0 29 4 0 0 286 0 8 4 4 1 5 87 0 0 17 0 0 Malaise      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Pyrexia      subjects affected / exposed 0 / 1458 (0.00%) 43 / 1458 (2.95%) 14 / 718 (1.95%) 0 / 237 (0.00%) 0 / 483 (0.00%) 2 / 237 (0.84%) 12 / 483 (2.48%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 6 / 405 (1.48%) 11 / 863 (1.27%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 37 / 2368 (1.56%) 23 / 1173 (1.96%) 4 / 202 (1.98%) 2 / 418 (0.48%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 13 / 2410 (0.54%) 10 / 957 (1.04%) 0 / 16 (0.00%) 1 / 16 (6.25%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 45 14 0 0 2 13 0 0 0 0 0 0 6 11 0 0 0 37 24 4 2 0 0 0 0 0 0 0 0 0 0 13 10 0 1 0 0 0 0 0 0 0 0 0 Pyrexia (FEVER) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 184 / 1458 (12.62%) 87 / 718 (12.12%) 0 / 237 (0.00%) 0 / 483 (0.00%) 13 / 237 (5.49%) 28 / 483 (5.80%) 0 / 718 (0.00%) 243 / 3109 (7.82%) 16 / 518 (3.09%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 21 / 405 (5.19%) 41 / 863 (4.75%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 224 / 2368 (9.46%) 121 / 1173 (10.32%) 0 / 202 (0.00%) 18 / 418 (4.31%) 0 / 418 (0.00%) 1 / 16 (6.25%) 1 / 15 (6.67%) 2 / 16 (12.50%) 14 / 433 (3.23%) 0 / 487 (0.00%) 33 / 487 (6.78%) 9 / 32 (28.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 154 / 2410 (6.39%) 0 / 957 (0.00%) 3 / 16 (18.75%) 4 / 16 (25.00%) 4 / 4 (100.00%) 4 / 12 (33.33%) 1 / 38 (2.63%) 40 / 1538 (2.60%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 8 / 260 (3.08%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 205 96 0 0 13 28 0 257 16 0 0 0 21 41 0 0 0 237 126 0 18 0 1 1 3 14 0 35 12 0 0 154 0 3 4 4 4 1 42 0 0 8 0 0 Immune system disorders Seasonal allergy      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Social circumstances Menarche      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 1 / 16 (6.25%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Reproductive system and breast disorders Dysmenorrhoea      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 1 / 16 (6.25%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Respiratory, thoracic and mediastinal disorders Cough      subjects affected / exposed 0 / 1458 (0.00%) 15 / 1458 (1.03%) 5 / 718 (0.70%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 22 / 2368 (0.93%) 14 / 1173 (1.19%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 18 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 22 14 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Rhinorrhoea      subjects affected / exposed 0 / 1458 (0.00%) 20 / 1458 (1.37%) 5 / 718 (0.70%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 1 / 16 (6.25%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 21 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Psychiatric disorders Anxiety      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 1 / 16 (6.25%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Irritability      subjects affected / exposed 0 / 1458 (0.00%) 15 / 1458 (1.03%) 6 / 718 (0.84%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 16 7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Irritability (IRRITABILITY) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 932 / 1458 (63.92%) 431 / 718 (60.03%) 0 / 237 (0.00%) 0 / 483 (0.00%) 82 / 237 (34.60%) 191 / 483 (39.54%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 4 / 15 (26.67%) 8 / 16 (50.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 1343 615 0 0 82 191 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Injury, poisoning and procedural complications Animal bite      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 1 / 16 (6.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Arthropod bite      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 1 / 16 (6.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Concussion      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Contusion      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 1 / 16 (6.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Fall      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Foreign body ingestion      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Fracture      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Skin laceration      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Nervous system disorders Headache      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Headache (HEADACHE) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 1193 / 3109 (38.37%) 163 / 518 (31.47%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 15 / 405 (3.70%) 36 / 863 (4.17%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 191 / 2368 (8.07%) 86 / 1173 (7.33%) 0 / 202 (0.00%) 93 / 418 (22.25%) 0 / 418 (0.00%) 2 / 16 (12.50%) 0 / 15 (0.00%) 0 / 16 (0.00%) 143 / 433 (33.03%) 0 / 487 (0.00%) 228 / 487 (46.82%) 8 / 32 (25.00%) 1 / 27 (3.70%) 0 / 1538 (0.00%) 610 / 2410 (25.31%) 0 / 957 (0.00%) 10 / 16 (62.50%) 11 / 16 (68.75%) 3 / 4 (75.00%) 6 / 12 (50.00%) 13 / 38 (34.21%) 506 / 1538 (32.90%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 77 / 260 (29.62%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1573 185 0 0 0 15 36 0 0 0 211 99 0 93 0 4 0 0 143 0 307 8 1 0 610 0 12 14 6 8 13 656 0 0 88 0 0 Presyncope      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Somnolence (DROWSINESS) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 560 / 1458 (38.41%) 274 / 718 (38.16%) 0 / 237 (0.00%) 0 / 483 (0.00%) 27 / 237 (11.39%) 98 / 483 (20.29%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 1 / 15 (6.67%) 4 / 16 (25.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 713 354 0 0 27 98 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Speech disorder developmental      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 1 / 15 (6.67%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Blood and lymphatic system disorders Lymphadenopathy      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 40 / 2410 (1.66%) 7 / 957 (0.73%) 0 / 16 (0.00%) 1 / 16 (6.25%) 1 / 4 (25.00%) 0 / 12 (0.00%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 40 7 0 2 1 0 1 0 0 0 0 0 0 Gastrointestinal disorders Abdominal discomfort      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Abdominal pain      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 2 / 32 (6.25%) 1 / 27 (3.70%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Diarrhea (DIARRHEA) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 320 / 3109 (10.29%) 40 / 518 (7.72%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 21 / 405 (5.19%) 39 / 863 (4.52%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 305 / 2368 (12.88%) 160 / 1173 (13.64%) 0 / 202 (0.00%) 19 / 418 (4.55%) 0 / 418 (0.00%) 1 / 16 (6.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 18 / 433 (4.16%) 0 / 487 (0.00%) 66 / 487 (13.55%) 5 / 32 (15.63%) 1 / 27 (3.70%) 0 / 1538 (0.00%) 104 / 2410 (4.32%) 0 / 957 (0.00%) 1 / 16 (6.25%) 1 / 16 (6.25%) 2 / 4 (50.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 138 / 1538 (8.97%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 26 / 260 (10.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 364 46 0 0 0 21 39 0 0 0 338 179 0 19 0 2 0 0 18 0 75 6 1 0 104 0 2 1 2 0 0 151 0 0 27 0 0 Diarrhoea      subjects affected / exposed 0 / 1458 (0.00%) 31 / 1458 (2.13%) 17 / 718 (2.37%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 5 / 405 (1.23%) 1 / 863 (0.12%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 22 / 2368 (0.93%) 13 / 1173 (1.11%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 31 17 0 0 0 0 0 0 0 0 0 0 5 1 0 0 0 24 13 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Nausea      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 1 / 27 (3.70%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Teething      subjects affected / exposed 0 / 1458 (0.00%) 18 / 1458 (1.23%) 7 / 718 (0.97%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 18 7 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Vomiting      subjects affected / exposed 0 / 1458 (0.00%) 27 / 1458 (1.85%) 15 / 718 (2.09%) 0 / 237 (0.00%) 0 / 483 (0.00%) 7 / 237 (2.95%) 6 / 483 (1.24%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 7 / 405 (1.73%) 2 / 863 (0.23%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 41 / 2368 (1.73%) 13 / 1173 (1.11%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 2 / 27 (7.41%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 1 / 12 (8.33%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 29 17 0 0 7 6 0 0 0 0 0 0 7 2 0 0 0 42 13 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 1 0 0 0 0 0 0 0 Vomiting (VOMITING) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 122 / 3109 (3.92%) 13 / 518 (2.51%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 16 / 405 (3.95%) 16 / 863 (1.85%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 144 / 2368 (6.08%) 68 / 1173 (5.80%) 0 / 202 (0.00%) 7 / 418 (1.67%) 0 / 418 (0.00%) 1 / 16 (6.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 11 / 433 (2.54%) 0 / 487 (0.00%) 22 / 487 (4.52%) 2 / 32 (6.25%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 61 / 2410 (2.53%) 0 / 957 (0.00%) 0 / 16 (0.00%) 1 / 16 (6.25%) 1 / 4 (25.00%) 2 / 12 (16.67%) 1 / 38 (2.63%) 55 / 1538 (3.58%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 8 / 260 (3.08%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 125 14 0 0 0 16 16 0 0 0 150 69 0 7 0 1 0 0 11 0 24 3 0 0 61 0 0 1 1 2 1 57 0 0 9 0 0 Skin and subcutaneous tissue disorders Dermatitis diaper      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Erythema      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Pruritus      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Rash      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Rash macular      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 1 / 16 (6.25%) 0 / 4 (0.00%) 0 / 12 (0.00%) 1 / 38 (2.63%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 Urticaria      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 1 / 16 (6.25%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Musculoskeletal and connective tissue disorders Arthralgia      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 1 / 16 (6.25%) 0 / 16 (0.00%) 1 / 4 (25.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 Arthralgia (JOINT PAIN) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 235 / 3109 (7.56%) 35 / 518 (6.76%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 4 / 405 (0.99%) 9 / 863 (1.04%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 53 / 2368 (2.24%) 30 / 1173 (2.56%) 0 / 202 (0.00%) 23 / 418 (5.50%) 0 / 418 (0.00%) 1 / 16 (6.25%) 0 / 15 (0.00%) 0 / 16 (0.00%) 26 / 433 (6.00%) 0 / 487 (0.00%) 69 / 487 (14.17%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 129 / 2410 (5.35%) 0 / 957 (0.00%) 1 / 16 (6.25%) 1 / 16 (6.25%) 1 / 4 (25.00%) 1 / 12 (8.33%) 1 / 38 (2.63%) 110 / 1538 (7.15%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 22 / 260 (8.46%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 265 39 0 0 0 4 9 0 0 0 53 33 0 23 0 1 0 0 26 0 80 1 0 0 129 0 1 1 2 1 1 127 0 0 25 0 0 Costochondritis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 1 / 32 (3.13%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Myalgia      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 1 / 16 (6.25%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Myalgia (MUSCLE PAIN) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 561 / 3109 (18.04%) 81 / 518 (15.64%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 6 / 405 (1.48%) 15 / 863 (1.74%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 106 / 2368 (4.48%) 50 / 1173 (4.26%) 0 / 202 (0.00%) 73 / 418 (17.46%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 76 / 433 (17.55%) 0 / 487 (0.00%) 167 / 487 (34.29%) 4 / 32 (12.50%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 350 / 2410 (14.52%) 0 / 957 (0.00%) 2 / 16 (12.50%) 5 / 16 (31.25%) 4 / 4 (100.00%) 1 / 12 (8.33%) 3 / 38 (7.89%) 192 / 1538 (12.48%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 31 / 260 (11.92%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 657 92 0 0 0 6 15 0 0 0 114 54 0 73 0 0 0 0 76 0 213 5 0 0 350 0 2 7 6 1 3 230 0 0 38 0 0 Neck pain      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 1 / 16 (6.25%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Infections and infestations COVID-19      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 2 / 202 (0.99%) 8 / 418 (1.91%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 6 / 487 (1.23%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 8 0 0 0 0 0 0 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Ear infection      subjects affected / exposed 0 / 1458 (0.00%) 10 / 1458 (0.69%) 8 / 718 (1.11%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 10 8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Enterobiasis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 2 / 16 (12.50%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 Hand-foot-and-mouth disease      subjects affected / exposed 0 / 1458 (0.00%) 16 / 1458 (1.10%) 11 / 718 (1.53%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 16 11 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Otitis media      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 4 / 237 (1.69%) 4 / 483 (0.83%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 4 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Periorbital cellulitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 1 / 27 (3.70%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Rhinitis      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 14 / 2368 (0.59%) 12 / 1173 (1.02%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 14 12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Upper respiratory tract infection      subjects affected / exposed 0 / 1458 (0.00%) 0 / 1458 (0.00%) 0 / 718 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 237 (0.00%) 0 / 483 (0.00%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 4 / 518 (0.77%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 0 / 15 (0.00%) 0 / 16 (0.00%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 3 / 260 (1.15%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 Metabolism and nutrition disorders Decreased appetite (DECREASED APPETITE) alternative assessment type: Systematic      subjects affected / exposed 0 / 1458 (0.00%) 511 / 1458 (35.05%) 236 / 718 (32.87%) 0 / 237 (0.00%) 0 / 483 (0.00%) 29 / 237 (12.24%) 89 / 483 (18.43%) 0 / 718 (0.00%) 0 / 3109 (0.00%) 0 / 518 (0.00%) 0 / 518 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 405 (0.00%) 0 / 863 (0.00%) 0 / 1173 (0.00%) 0 / 2368 (0.00%) 0 / 260 (0.00%) 0 / 2368 (0.00%) 0 / 1173 (0.00%) 0 / 202 (0.00%) 0 / 418 (0.00%) 0 / 418 (0.00%) 0 / 16 (0.00%) 2 / 15 (13.33%) 2 / 16 (12.50%) 0 / 433 (0.00%) 0 / 487 (0.00%) 0 / 487 (0.00%) 0 / 32 (0.00%) 0 / 27 (0.00%) 0 / 1538 (0.00%) 0 / 2410 (0.00%) 0 / 957 (0.00%) 0 / 16 (0.00%) 0 / 16 (0.00%) 0 / 4 (0.00%) 0 / 12 (0.00%) 0 / 38 (0.00%) 0 / 1538 (0.00%) 0 / 3109 (0.00%) 0 / 957 (0.00%) 0 / 260 (0.00%) 0 / 2410 (0.00%) 0 / 202 (0.00%)      occurrences all number 0 619 279 0 0 29 89 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
10 Sep 2019	Amendment 3: Updated to allow an additional 2250 Phase 2/3 selected-dose Participants 5 years of age, to enlarge the size of the pediatric safety database. This has resulted in the total number of participants in this portion of the study increasing to approximately 9000 participants. Included blood draws, procedures, and objectives for potential troponin I testing in participants ≥5 to 12 and ≥12 to 16 years. Added the rationale for collecting serum samples for potential troponin I testing.Revised an objective and corresponding endpoint to describe severe COVID-19 cases in participants in the selected-dose portion of the study. Clarified the process for participants who become eligible for receipt of BNT162b2 or another COVID-19 vaccine prior to Visit 5 (6-month follow-up visit). Added a second definition of symptoms of severe COVID-19 disease per the CDC definition. Clarified instructions on how to unblind participants at the 6-month follow-up visit. Updated information on the recording of nonstudy vaccination and concomitant medications.
05 Mar 2021	Amendment 1: Added 2 age groups to the study: participants ≥2 to <5 years and ≥6 months to <2 years of age, to also study safety and immunogenicity in these age groups. Updated efficacy objectives to apply across ages in which immunobridging has been successful, if 22 cases are accrued. Made updates to match Pfizer’s response to 04 February 2021 CBER comments regarding this study, ie: Exclusion criterion 3 applied to all study participants rather than just to Phase 1 participants. References to “noninferiority” updated to “immunobridging.” Made additions to the exclusion criteria for previous or current diagnosis of MIS-C. Added to the exclusion criteria receipt of any passive antibody therapy specific to COVID-19 within 90 days prior to enrollment. Specified that placebo recipients who decline BNT162b2 will be followed for 24 months (Visits X and Y). Temporary delay of study intervention criteria regarding nonstudy vaccination updated to be most permissive, ie, to allow easier scheduling around childhood routine vaccinations. Added the following symptoms as prompts to complete the COVID-19/MIS-C illness e-diary: Inability to eat/poor feeding in participants <5 years of age; Abdominal pain; Hospitalization due to confirmed COVID-19 infection. Following updates made to the first confirmed COVID-19 case definition to accommodate inclusion of participants 5 years of age: Definition of diarrhea added. Inability to eat/poor feeding in participants 5 years of age added as an additional symptom. Definition of SARS-CoV-2–related hospitalization added. RR and HR required to meet the SARS-CoV-2–related severe case definition specified by participant age. Table 4 inserted. Added that cell-mediated immune responses will be described following isolation of PBMCs in a subset of Phase 2/3 participants ≥10 years of age. Corresponding visit (Visit 3) added approximately 7 days after Dose 2.
06 Aug 2021	Amendment 2: Made the following updates in response to commitments made to CBER concerning myocarditis and pericarditis: Insertion of additional row in risk assessment table in risk assessment section. Addition of myocarditis and pericarditis in Adverse Events of Special Interest section. Addition of a procedure to any visit that occurs sooner than 1 month after any vaccination. Addition of an unplanned visit to capture data pertaining to myocarditis and pericarditis. Revised protocol title to reflect the changes in age and dose evaluation.Updated to allow an additional 2250 Phase 2/3 selected-dose participants to enlarge the size of the pediatric safety database. Added Phase 1/2/3 evaluation of lower dose levels for children and young adults with corresponding objectives. Revised the order of Visit 1 activities to clarify when procedures should be conducted in relation to study intervention administration when the visit occurs over 2 consecutive days. Added updates and reformatted activities in the SoA. Removed the requirement to conduct a potential COVID-19 convalescent visit following each potential COVID-19 illness visit. The collection of the blood sample was to support an exploratory endpoint, which will be addressed with external data and thereby reduce burden to participants and caregivers. Added a country-specific appendix that allows flexibility to conduct scheduled follow-up visits in the participant’s home, ie, site-arranged home health visits, as permitted per local guidelines (applicable to Poland only).
29 Sep 2021	Amendment 4: Revised the success criterion for the efficacy hypotheses to the lower limit of 95% CI 30, in response to regulatory feedback. Added Section 1.1.1, requiring the avoidance of strenuous or endurance exercise 4 days prior to Visit 1 through Visit 1 and from Visit 2 through Visit 3 for the potential troponin I testing subset. Clarified that Phase 2/3 selected-dose participants who originally received active vaccine and are unblinded before Visit 5 will complete the original SoA (Section 1.3.3) before transitioning to the SoA in Section 1.3.3.1.
15 Nov 2021	Amendment 5: Based on the 10-μg immunobridging data in the ≥5- to 12-year age group, revised Phase 1/2/3 evaluation of lower dose schedules for children and adolescents. Revised age range for the oldest age group. Revised corresponding objectives, estimands, and endpoints. Revised corresponding SoA and procedures. Revised details in the statistical methods sections. Added flexibility for Visit 5 to be conducted as a telephone visit for the 4500 participants included to enlarge the size of the pediatric safety database, reducing the burden on the participant or participant’s parent(s)/legal guardian. Included an exploratory objective to describe the immune response to emerging VOCs. Added the instruction that participants who receive COVID-19 vaccines outside of the study from protocol amendment 5 onwards should be withdrawn to maintain the appropriate assessment of the study intervention. Removed the lifestyle consideration related to strenuous or endurance exercise (potential troponin I testing group only) following regulatory feedback. Updated the appendix for SAE reporting to include guidance on how to report SAEs to Pfizer Safety via an electronic data collection tool.
04 Jan 2022	Amendment 6: The primary immunogenicity analysis demonstrated that the immune response elicited by BNT162b2 in participants ≥2 to 5 years of age (2 doses at 3 μg) did not meet immunobridging criteria when compared to participants 16 to 25 years of age from the C4591001 study. As a result, and given the emerging data in individuals 16 years of age and older, an additional (third) dose of BNT162b2 will be administered to all Phase 1 dose-finding and Phase 2/3 selected-dose participants: Added corresponding objectives, estimands, and endpoints. Added corresponding SoA and procedures. Added details in the statistical methods sections. Cell-mediated immune responses will also be described following isolations of PBMCs in a subset of Phase 2/3 participants who receive a third dose. An additional 4500 Phase 2/3 selected-dose participants ≥6 months to 2 years and ≥2 to 5 years of age are permitted to enroll to enlarge the size of the pediatric safety database. Clarified that participants who decline the opportunity to receive third dose should be withdrawn. Clarified that the interval between the second and third doses will be based on the participant’s age at the time of enrollment. Clarified that the dose level of BNT162b2 will be based on age at the time of vaccination. As the asymptomatic efficacy objective is now restricted to participants ≥5 to 12 years of age, in the Phase 2/3 selected-dose portion, participants ≥6 months to 5 years of age who enrolled before protocol amendment 6 will no longer have a blood sample for immunogenicity testing at Visit 5 (6-month follow-up). Time frames for prohibited nonstudy vaccines were simplified. For the option of a 3-μg dose level, an additional unit dose strength was added. For participants 5 years of age, all positive RT-PCR cases confirmed by the central laboratory will undergo BioFire testing.
10 Mar 2022	Amendment 7: Given the emerging data in individuals 16 years of age and older, an additional (third) dose of BNT162b2 at least 5 months after Dose 2 to all Phase 2/3 participants enrolled to support obtaining serum samples for potential troponin I testing (≥5 to12 years of age, placebo-controlled, and ≥12 to 16 years of age, open-label):Clarified both symptomatic and asymptomatic COVID-19 infection will result in temporary delay of enrollment, randomization, or study intervention administration. Clarified that the dose interval for Phase 2/3 selected-dose participants enrolled in the ≥2 to 5 years age group who originally received placebo and will turn 5 years of age prior to crossing over to active vaccine will be the same as for the ≥5 to 12 years age group (ie, third dose administered at least 6 months after the second dose). Additional clarification for Phase 2/3 selected-dose parents/legal guardians that decline the blinded third dose. Added flexibility to inclusion and exclusion criteria (based on investigator’s judgment) for Phase 1 dose-finding participants when receiving Dose 3. Clarified that, for Phase 1 dose-finding participants, height and weight should be collected once at Visit 1 only as part of the physical examination; likewise, the participant’s randomization number and study intervention allocation are obtained using the IRT system at Visit 1 only. The timing of cases for these 2 groups are similar, therefore making it more likely to compare cases of the same variant. Added collection of maternal COVID-19 immunization and breastfeeding data for participants who are ≥6 months to 2 years of age in the Phase 2/3 selected-dose portion of the study. Updated the risk assessment to align with the current version of the IB.
28 Apr 2023	Amendment 8: Updated schedules of assessments and protocol text to identify study visits that no longer need to be completed.Updated study procedures to describe site actions following approval of protocol amendment 8.Removed the lower-dose-evaluation substudy of the protocol. The FDA has approved the request for the lower-dose evaluation postmarketing commitment release in November 2022. Provided further guidance for participants withdrawal from the study for Phase 2/3 selected-dose parents/legal guardians that decline the blinded third dose. Added a statement that participants in Mexico will not self collect nasal swabs per Mexican regulatory request. Clarified that the window for provision of a third dose of BNT162b2 for participants ≥5 years of age to 12 years of age in the US is in line with changing regulatory requirements (emergency use approvals). Removed blood sample collection for immunogenicity testing at certain study visits for Phase 1 dose-finding participants and Phase 2/3 selected-dose participants who are part of the immunogenicity subset to reduce the burden of procedures on participants and caregivers for those enrolling in study C4591048. Secondary/exploratory objectives with corresponding text throughout the protocol removed: To describe the efficacy of prophylactic BNT162b2 against asymptomatic infection in participants ≥5 to 12 years age in the selected-dose portion of the study without evidence of past SARS-CoV-2 infection. To describe the serological responses in Phase 2/3 participants in the selected-dose portion of the study to BNT162b2 at the dose level selected in each age group in cases of: Confirmed COVID-19 with and without coinfection or Confirmed severe COVID-19 or SARS-CoV-2 infection without confirmed COVID-19. Added exploratory objective to describe the incidence of confirmed COVID-19 through the entire study follow-up period. Added corresponding estimands, endpoints, and statistical analysis methods.
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

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