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Clinical Trial Results:
A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

Summary
EudraCT number	2021-000281-15
Trial protocol	Outside EU/EEA
Global end of trial date	15 Mar 2024

Results information
Results version number	v2(current)
This version publication date	28 Oct 2025
First version publication date	30 Sep 2024
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

mRNA-1273-P204

ISRCTN number

US NCT number

NCT04796896

WHO universal trial number (UTN)

Sponsor organisation name

ModernaTX, Inc.

Sponsor organisation address

325 Binney Street, Cambridge, United States, 02142

Public contact

Moderna Clinical Trials Support Center, ModernaTX, Inc., +1 877-777-7187, clinicaltrials@modernatx.com

Scientific contact

Moderna Clinical Trials Support Center, ModernaTX, Inc., +1 877-777-7187, clinicaltrials@modernatx.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-005791-PIP01-20

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Analysis stage

Final

Date of interim/final analysis

17 May 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

15 Mar 2024

Global end of trial reached?

Yes

Global end of trial date

15 Mar 2024

Was the trial ended prematurely?

Main objective of the trial

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injections in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an optional booster dose (BD) (in Parts 1 and 2).

Protection of trial subjects

This study was conducted in accordance with the protocol and consensus ethical principles derived from international guidelines including the Declaration of Helsinki, and Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, applicable International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, and other applicable laws and regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Mar 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 11529

Country: Number of subjects enrolled

Canada: 413

Worldwide total number of subjects

11942

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

2837

Children (2-11 years)

9105

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

The study was conducted in 3 parts: Part 1 (open-label; dose-escalation and age de-escalation), Part 2 (placebo-controlled), and Part 3 (open-label; lower dose regimen).

Screening details

A comparison to the mRNA-1273-P301 (NCT04470427) study's efficacy data was performed on a sub-group of mRNA-1273-P301 (P301) study participants aged 18-25 (N=296). Study “Completion” and “Not Completion” data reported in the Participant Flow were collected by “Overall Study” (that is, as 1 period regardless if a booster dose was received).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Blinding implementation details

Part 1 and Part 3 were open label. Part 2 was conducted in an observer-blind manner.

Are arms mutually exclusive

Yes

Part 1 (6-11 Years): mRNA-1273 50 µg

Arm description

Participants received 2 doses of 50 micrograms (µg) mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 1 (6-11 Years): mRNA-1273 100 µg

Arm description

Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 1 (2-5 Years): mRNA-1273 25 µg

Arm description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 1 (2-5 Years): mRNA-1273 50 µg

Arm description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 1 (6-23 Months): mRNA-1273 25 µg

Arm description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 2 (6-11 Years): Placebo

Arm description

Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 50 μg of mRNA-1273 after the availability of a coronavirus disease 2019 (COVID-19) vaccine under Emergency Use Authorization (EUA).

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate, Sterile concentrate

Routes of administration

Intramuscular use, Intramuscular use

Dosage and administration details

Placebo matched to mRNA-1273 was administered per schedule specified in the arm description.

Part 2 (6-11 Years): mRNA-1273 50 µg

Arm description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 2 (2-5 Years): Placebo

Arm description

Participants received 2 doses of matching placebo by IM injection approximately 28 days apart (Day 1 and Day 29). Participants were offered crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

Placebo matched to mRNA-1273 was administered per schedule specified in the arm description.

Part 2 (2-5 Years): mRNA-1273 25 µg

Arm description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 2 (6-23 Months): Placebo

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

Placebo matched to mRNA-1273 was administered per schedule specified in the arm description.

Part 2 (6-23 Months): mRNA-1273 25 µg

Arm description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg

Arm description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).

Arm type

Experimental

Investigational medicinal product name

mRNA-1273

Investigational medicinal product code

Other name

Pharmaceutical forms

Sterile concentrate

Routes of administration

Intramuscular use

Dosage and administration details

mRNA-1273 was administered per dose and schedule specified in the arm description.

Number of subjects in period 1	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
Started	380	371	75	149	150	1004	3011	1008	3040	669	1995	90
Received First Injection	380	371	75	149	150	997	3005	1007	3031	667	1993	90
Received Second Injection	379	371	75	149	150	974	2995	984	3007	649	1979	84
Received First Injection in Open-label	0 ^[1]	0 ^[2]	0 ^[3]	0 ^[4]	0 ^[5]	702	0 ^[6]	640	0 ^[7]	444	0 ^[8]	0 ^[9]
Received Booster Dose	230 ^[10]	249 ^[11]	40 ^[12]	99 ^[13]	125	469 ^[14]	2002 ^[15]	282 ^[16]	1301 ^[17]	237 ^[18]	1016 ^[19]	70
Received Crossover Vaccination	0 ^[20]	0 ^[21]	0 ^[22]	0 ^[23]	0 ^[24]	702	0 ^[25]	640	0 ^[26]	444	0 ^[27]	0 ^[28]
Completed	307	316	55	131	105	556	2329	515	2086	366	1387	51
Not completed	73	55	20	18	45	448	682	493	954	303	608	39
Adverse event, serious fatal	-	-	-	-	-	-	-	-	1	-	-	-
Consent withdrawn by subject	36	31	11	8	16	162	299	149	303	94	192	16
Physician decision	1	-	-	-	-	3	18	1	7	-	5	-
Other Than Specified	6	5	3	2	6	31	86	66	388	48	258	4
Adverse event, non-fatal	1	-	-	-	-	1	1	-	1	1	1	-
Protocol Deviation	-	-	-	1	1	2	2	2	2	1	-	-
Received Emergency Use Authorization (EUA) Vaccine	5	4	-	3	1	194	37	222	29	115	9	1
Lost to follow-up	24	15	6	4	21	55	237	52	221	43	142	18
Missing	-	-	-	-	-	-	2	1	2	1	1	-

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[15] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[16] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[17] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[18] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[19] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[20] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[21] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[22] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[23] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[24] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received booster dose.
[25] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[26] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.
[27] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received first injection in open-label.
[28] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: These are the number of participants who received crossover vaccination.

Baseline characteristics

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Reporting group title

Part 1 (6-11 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 micrograms (µg) mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (6-11 Years): mRNA-1273 100 µg

Reporting group description

Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (2-5 Years): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (2-5 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (6-23 Months): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (6-11 Years): Placebo

Reporting group description

Reporting group title

Part 2 (6-11 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (2-5 Years): Placebo

Reporting group description

Reporting group title

Part 2 (2-5 Years): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (6-23 Months): Placebo

Reporting group description

Reporting group title

Part 2 (6-23 Months): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).

Reporting group values	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg	Total
Number of subjects	380	371	75	149	150	1004	3011	1008	3040	669	1995	90	11942
Age Categorical
Units: Subjects
Infants and toddlers (28 days - 23 months)	0	0	0	0	150	0	0	11	18	669	1989	0	2837
Children (2 - 11 years)	380	371	75	149	0	1004	3011	997	3022	0	6	90	9105
Adults (between 18 and 64 years)	0	0	0	0	0	0	0	0	0	0	0	0	0
Gender Categorical
Units: Subjects
Female	185	199	39	69	67	516	1456	498	1490	341	981	34	5875
Male	195	172	36	80	83	488	1555	510	1550	328	1014	56	6067
Race
Units: Subjects
White	266	284	54	128	124	676	1960	793	2307	527	1568	48	8735
Black or African American	34	13	3	7	3	94	310	38	142	18	62	37	761
Asian	28	25	8	3	7	100	297	51	191	38	94	2	844
American Indian or Alaska Native	0	2	0	0	1	3	15	3	11	0	7	2	44
Native Hawaiian or Other Pacific Islander	1	0	0	0	0	0	4	3	5	0	0	0	13
Other	3	10	7	1	3	22	62	16	43	7	33	0	207
Multiple	39	31	3	10	11	98	330	100	324	76	215	0	1237
Not Reported	9	4	0	0	0	10	23	4	13	2	11	1	77
Unknown	0	2	0	0	1	1	10	0	4	1	5	0	24
Ethnicity
Units: Subjects
Hispanic or Latino	72	69	24	17	15	183	562	142	429	94	257	29	1893
Not Hispanic or Latino	304	296	51	129	133	811	2421	857	2593	568	1719	58	9940
Not Reported	3	3	0	3	1	5	21	8	13	6	17	1	81
Unknown	1	3	0	0	1	5	7	1	5	1	2	2	28

Subject analysis set title

Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on Booster Dose (BD)-Day 1.

Subject analysis set title

Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (6-11 Years): mRNA-1273 50 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (6-11 Years): mRNA-1273 100 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (2-5 Years): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (2-5 Years): mRNA-1273 50 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (6-23 Months): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 2 (6-11 Years): Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Part 2 (6-11 Years): mRNA-1273 50 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 2 (2-5 Years): Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Part 2 (2-5 Years): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 2 (6-23 Months): Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Part 2 (6-23 Months): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 3 (6-11 Years): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 3 doses of 25 µg mRNA-1273 by IM injection on Days 1, 29, and 149.

Subject analysis set title

Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Subject analysis set type

Per protocol

Subject analysis set description

Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

Subject analysis set title

Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a placebo in the blinded phase and then crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

Subject analysis set title

Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a placebo in the blinded phase and then crossover vaccination with 25 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA. Adverse Events were collected from the first cross-over dose until the first booster dose.

Subject analysis set title

Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 3 (6-11 Years): BD mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.

Subject analysis set title

Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 3 (6-11 Years): BD mRNA-1273 25 µg

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.

Subject analysis set title

6-11 Years: BD mRNA-1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6-11 Yrs: BD mRNA-1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273.214 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis sets values	Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg	Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg	Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg	Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): mRNA-1273 25 µg	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg	Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)	Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)	Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)	BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg	BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg	Part 3 (6-11 Years): BD mRNA-1273 25 µg	Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg	Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg	Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg	Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg	Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg	Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg	Part 3 (6-11 Years): BD mRNA-1273 25 µg	6-11 Years: BD mRNA-1273 25 μg	6-11 Yrs: BD mRNA-1273.214 25 μg	6 Months-5 Yrs: BD mRNA-1273 10 μg	6 Months-5 Yrs: BD mRNA-1273 25 μg	6 Months-5 Yrs: BD mRNA-1273.214 10 μg	6 Months-5 Yrs: BD mRNA-1273.214 25 μg
Number of subjects	229	247	122	31	59	9	38	5	37	411	1879	380	371	69	155	150	995	3007	1007	3031	666	1994	90	296	701	640	444	103	189	56	505	2261	8	20	58	123	52	2766	184	212	89	2771	28
Age Categorical
Units: Subjects
Infants and toddlers (28 days - 23 months)																								0
Children (2 - 11 years)																								0
Adults (between 18 and 64 years)																								296
Age Continuous
Units: years
arithmetic mean (standard deviation)	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )	( )
Gender Categorical
Units: Subjects
Female																								153
Male																								143
Race
Units: Subjects
White																								207
Black or African American																								29
Asian																								30
American Indian or Alaska Native																								3
Native Hawaiian or Other Pacific Islander																								2
Other																								8
Multiple																								14
Not Reported																								3
Unknown																								0
Ethnicity
Units: Subjects
Hispanic or Latino																								78
Not Hispanic or Latino																								216
Not Reported																								0
Unknown																								2

End points

Top of page

Reporting group title

Part 1 (6-11 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 micrograms (µg) mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (6-11 Years): mRNA-1273 100 µg

Reporting group description

Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (2-5 Years): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (2-5 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (6-23 Months): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (6-11 Years): Placebo

Reporting group description

Reporting group title

Part 2 (6-11 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (2-5 Years): Placebo

Reporting group description

Reporting group title

Part 2 (2-5 Years): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (6-23 Months): Placebo

Reporting group description

Reporting group title

Part 2 (6-23 Months): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).

Subject analysis set title

Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on Booster Dose (BD)-Day 1.

Subject analysis set title

Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 1 (6-11 Years): mRNA-1273 50 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (6-11 Years): mRNA-1273 100 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (2-5 Years): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (2-5 Years): mRNA-1273 50 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 1 (6-23 Months): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 2 (6-11 Years): Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Part 2 (6-11 Years): mRNA-1273 50 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 2 (2-5 Years): Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Part 2 (2-5 Years): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 2 (6-23 Months): Placebo

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Part 2 (6-23 Months): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Subject analysis set title

Part 3 (6-11 Years): mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received 3 doses of 25 µg mRNA-1273 by IM injection on Days 1, 29, and 149.

Subject analysis set title

Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Subject analysis set type

Per protocol

Subject analysis set description

Participants (young adults; 18-25 years of age) received 100 μg mRNA-1273 on a 2 injection schedule in Study mRNA-1273-P301 (P301).

Subject analysis set title

Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a placebo in the blinded phase and then crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

Subject analysis set title

Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)

Subject analysis set type

Safety analysis

Subject analysis set description

Subject analysis set title

BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

Part 3 (6-11 Years): BD mRNA-1273 25 µg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.

Subject analysis set title

Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

Part 3 (6-11 Years): BD mRNA-1273 25 µg

Subject analysis set type

Per protocol

Subject analysis set description

Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.

Subject analysis set title

6-11 Years: BD mRNA-1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6-11 Yrs: BD mRNA-1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273.214 10 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Subject analysis set title

6 Months-5 Yrs: BD mRNA-1273.214 25 μg

Subject analysis set type

Safety analysis

Subject analysis set description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Primary: Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

Top of page

End point title

Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) ^[1]

End point description

Solicited ARs collected in an electronic diary (eDiary). Local ARs: injection site pain, erythema (redness), swelling/induration (hardness); and axillary (underarm) swelling or tenderness ipsilateral to site of injection. Systemic ARs: fever, headache, fatigue, myalgia, arthralgia, nausea/vomiting, and chills. Note, not all solicited ARs considered adverse events (AEs). Investigator reviewed whether solicited AR was also to be recorded as an AE. A Summary of serious AEs (SAEs) and nonserious AEs ("Other"), regardless of causality, is located in "Reported Adverse Events" section. Solicited Safety Set: all participants in Safety Set (Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection) who contributed any solicited AR data, that is, had at least 1 post-baseline solicited safety assessment. Per prespecified analysis, data for this endpoint was not collected for mRNA-1273.214 treatment groups.

End point type

Primary

End point timeframe

7 days post-vaccination

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: The endpoint is descriptive in nature.

End point values	Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg	Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg	Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg	Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): mRNA-1273 25 µg	Part 3 (6-11 Years): BD mRNA-1273 25 µg
Number of subjects analysed	228	247	122	31	58	8	38	5	18	405	1853	380	371	69	153	150	994	3005	998	3014	664	1991	90	56
Units: participants	216	221	93	24	46	7	36	4	12	358	1726	374	367	62	147	141	823	2983	797	2800	596	1889	66	30

No statistical analyses for this end point

Primary: Parts 1, 2, and 3: Number of Participants With Unsolicited AEs

Top of page

End point title

Parts 1, 2, and 3: Number of Participants With Unsolicited AEs ^[2]

End point description

An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time [PT]/partial thromboplastin time [PTT]) or other safety assessment, including one that worsened from baseline and was considered clinically significant in the medical and scientific judgment of the Investigator was recorded as an AE. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the "Reported Adverse Events" section and presented by each dose group separately. Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection. Per prespecified analysis, data for this endpoint was not collected for the mRNA-1273.214 and placebo only treatment groups.

End point type

Primary

End point timeframe

Up to 28 days post-vaccination

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: The endpoint is reporting statistics for specified arms only.

End point values	Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg	Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg	Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg	Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): mRNA-1273 25 µg
Number of subjects analysed	229	247	122	31	59	9	38	5	37	411	1879	380	371	69	155	150	3007	3031	1994	90
Units: participants	38	20	24	8	4	1	8	1	5	33	196	106	92	15	51	75	785	1087	883	17

No statistical analyses for this end point

Primary: Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study

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End point title

Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study ^[3]

End point description

An SAE was defined as any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly/birth defect, or was an important medical event. AESIs for mRNA‑1273 were identified based upon medical concepts that may be related to COVID‑19 or were of interest in COVID‑19 vaccine safety surveillance. MAAE was an AE that led to unscheduled visit to a healthcare practitioner. COVID-19/SARS-CoV-2 infections were considered clinical events for efficacy and not AEs. A summary of SAEs and all nonserious AEs (Other), regardless of causality, is located in "Reported Adverse Events" section and presented by each dose group separately. Safety Set of Parts 1 and 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection. Per prespecified analysis, data for this endpoint was not collected for participants who received only placebo.

End point type

Primary

End point timeframe

Up to 2 years

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: The endpoint is descriptive in nature.

End point values	Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg	Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 1 (2-5 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 2 (6 Months-5 Yrs): PS PBO - mRNA-1273 25 μg - BD 25 μg	Part 2 (6 Months-5 Years): PS mRNA-1273 25 μg - BD 25 μg	Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg	Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): mRNA-1273 25 µg	Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)	Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)	Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)	Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 10 μg	Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 10 μg	Part 2(6 M-5 Yr): PS PBO - mRNA-1273 25 μg - BD 1273.214 25 μg	Part 2(6 Months-5 Yrs): PS mRNA-1273 25 μg - BD 1273.214 25 μg	Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg - BD 1273.214 25 μg	Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273.214 25 μg
Number of subjects analysed	229	247	122	31	59	9	38	5	37	411	1879	380	371	69	155	150	3007	3031	1994	90	701	640	444	505	2261	8	20	58	123
Units: participants
SAEs	1	1	1	0	0	0	0	1	0	3	7	5	3	0	0	3	22	32	45	1	3	8	4	7	16	0	0	0	0
AESIs	1	0	2	0	0	0	0	0	1	2	9	5	7	0	1	2	19	13	13	0	3	1	1	2	0	0	0	0	0
MAAEs	85	71	59	16	23	4	17	3	10	137	616	175	169	32	80	105	1095	1687	1237	22	221	204	171	182	901	1	3	16	34
AEs Leading to Discontinuation	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	0

No statistical analyses for this end point

Primary: Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301

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End point title

Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301 ^[4]

End point description

Antibody values below lower limit of quantification (LLOQ) replaced by 0.5*LLOQ and values greater than upper limit of quantification (ULOQ) replaced by ULOQ if actual values were not available. LLOQ=18.5 AU/mL; ULOQ=45118 AU/mL. Per-Protocol (PP) Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection time; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb at baseline, not receiving highly active antiretroviral therapy (HAART); and had no major protocol deviations. Study P301 group: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. N=participants evaluable for this endpoint. As planned, Part 1 immunogenicity assessment did not serve as formal noninferiority hypothesis testing. It was intended to guide dose selection only.

End point type

Primary

End point timeframe

Day 57 P204/Day 57 P301

Notes
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): mRNA-1273 50 µg	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
Number of subjects analysed	201	56	51	68	97	309	294
Units: titer
geometric mean (confidence interval 95%)
ID50	1669.1 (1504.5 to 1851.6)	1890.2 (1603.8 to 2227.7)	1012.5 (848.2 to 1208.6)	1845.9 (1600.5 to 2128.9)	1782.6 (1542.0 to 2060.7)	1618.3 (1460.0 to 1793.9)	1321.9 (1196.5 to 1460.5)

Statistical Analysis 1

Statistical analysis description

The noninferiority of GM value (based on GLSM) was considered demonstrated if: The lower bound of the 95% confidence interval (CI) of the geometric mean ratio (GMR) was >0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).

Comparison groups

Part 2 (6-11 Years): mRNA-1273 50 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Number of subjects included in analysis

603

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

GMR

Point estimate

1.224

Confidence interval

level

95%

sides

2-sided

lower limit

1.061

upper limit

1.413

Primary: Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

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End point title

Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 ^[5]

End point description

Antibody values <LLOQ replaced by 0.5*LLOQ and values >ULOQ replaced by ULOQ if actual values were not available. LLOQ=10 AU/mL; ULOQ=111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection time; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb at baseline in Part 2, not receiving HAART; and had no major protocol deviations. Since number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after 3rd dose of mRNA-1273 25 μg, hypothesis testing was not performed. Study P301 group: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. N=participants evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 57 P204/Day 57 P301

Notes
[5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
Number of subjects analysed	289	268	61	294
Units: arbitrary units (AU)/milliliter (mL)
geometric mean (confidence interval 95%)	1394.1 (1267.7 to 1533.1)	1759.8 (1606.7 to 1927.4)	4368.6 (3339.6 to 5714.6)	1400.4 (1272.7 to 1541.0)

Statistical Analysis 2

Statistical analysis description

The noninferiority of GM value (based on GLSM) was considered demonstrated if the following were true: The lower bound of the 95% CI of the GMR was >0.667 based on the noninferiority margin of 1.5, and the GMR point estimate ≥0.8 (minimum threshold).

Comparison groups

Part 2 (6-23 Months): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Number of subjects included in analysis

562

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

GMR

Point estimate

1.257

Confidence interval

level

95%

sides

2-sided

lower limit

1.101

upper limit

1.434

Statistical Analysis 1

Statistical analysis description

Comparison groups

Part 2 (2-5 Years): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Number of subjects included in analysis

583

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

GMR

Point estimate

0.995

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.139

Primary: Parts 1 and 2: Seroresponse rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

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End point title

Parts 1 and 2: Seroresponse rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 ^[6]

End point description

Percentage of participants with seroresponse for pseudovirus neutralizing antibody ID50 are reported. Seroresponse: change from below LLOQ to equal above 4*LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ. LLOQ=18.5 AU/mL and ULOQ=45118 AU/mL for ID50 titer. PP Immunogenicity Subset as defined in Endpoint 4 above. Since the number of participants enrolled in Part 3 was substantially smaller than the planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, the hypothesis testing was not performed. PP immunogenicity subset. Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. ‘N’ = participants evaluable for this endpoint. As planned, Part 1 immunogenicity assessment did not serve as formal noninferiority hypothesis testing. It was intended to guide the dose selection only.

End point type

Primary

End point timeframe

Day 57 P204/Day 57 P301

Notes
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): mRNA-1273 50 µg	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
Number of subjects analysed	201	56	50	68	96	307	294
Units: percentage of participants
number (confidence interval 95%)
ID50	99.5 (97.3 to 99.9)	100 (93.6 to 100.0)	100 (92.9 to 100)	100 (94.7 to 100.0)	100 (96.2 to 100.0)	99.0 (97.2 to 99.8)	99.3 (97.6 to 99.9)

Statistical Analysis 1

Statistical analysis description

The noninferiority of the SRR was considered demonstrated if the following were true: The lower bound of the 95% CI of the SRR difference was >-10% based on the noninferiority margin of 10% and the SRR difference point estimate was ≥-5% (minimum threshold).

Comparison groups

Part 2 (6-11 Years): mRNA-1273 50 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Number of subjects included in analysis

601

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

percentage difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

1.6

Primary: Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

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End point title

Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301 ^[7]

End point description

Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as a change from below the LLOQ to equal above 4*LLOQ, or at least a 4-fold rise if baseline is equal to or above the LLOQ. LLOQ was 10 and ULOQ AU/mL was 111433 AU/mL. PP Immunogenicity Subset: all enrolled participants who received planned doses of the study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on binding antibody (bAb) specific to SARS-CoV-2 nucleocapsid protein at baseline in Part 2, not receiving HAART in participants with HIV; and had no major protocol deviations. Study P301 group: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. ‘N’ = participants evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 57 P204/Day 57 P301

Notes
[7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg
Number of subjects analysed	284	264	61	294
Units: percentage of participants
number (confidence interval 95%)	98.9 (96.9 to 99.8)	100 (98.6 to 100.0)	88.5 (77.8 to 95.3)	99.3 (97.6 to 99.9)

Statistical Analysis 2

Statistical analysis description

Comparison groups

Part 2 (6-23 Months): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Number of subjects included in analysis

558

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

percentage difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

2.4

Statistical Analysis 1

Statistical analysis description

Comparison groups

Part 2 (2-5 Years): mRNA-1273 25 µg v Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg

Number of subjects included in analysis

578

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

percentage difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

1.5

Primary: Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301

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End point title

Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301

End point description

Antibody values <LLOQ replaced by 0.5*LLOQ and values > ULOQ replaced by ULOQ if actual values were not available. LLOQ= 10 AU/mL; ULOQ= 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned mRNA-1273 vaccination in Part 1 open-label or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment, no major protocol deviations, and had not received off-study COVID-19 vaccine prior to BD-Day 29 visit. Study P301 group: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. N = Pre-booster SARS-CoV-2 negative participants evaluable for this endpoint. 'Part 1 6-23 months’ and ‘Part 1 2-5 years’ groups combined for noninferiority hypothesis testing. 'Part 1 and Part 2 groups of 6-11 years' combined for noninferiority hypothesis testing.

End point type

Primary

End point timeframe

BD-Day 29 P204/Day 57 P301

End point values	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg	BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg	BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
Number of subjects analysed	294	76	137
Units: AU/mL
geometric mean (confidence interval 95%)	1400.4 (1272.7 to 1541.0)	5457.2 (4525.7 to 6580.3)	5575.9 (5026.8 to 6184.9)

Statistical Analysis 2

Statistical analysis description

Comparison groups

Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg

Number of subjects included in analysis

431

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

GMR

Point estimate

3.982

Confidence interval

level

95%

sides

2-sided

lower limit

3.459

upper limit

4.583

Statistical Analysis 1

Statistical analysis description

Comparison groups

Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg

Number of subjects included in analysis

370

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

GMR

Point estimate

3.897

Confidence interval

level

95%

sides

2-sided

lower limit

3.158

upper limit

4.808

Primary: Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

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End point title

Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 ^[8]

End point description

Antibody values <LLOQ replaced by 0.5*LLOQ and values > ULOQ replaced by ULOQ if actual values were not available. LLOQ= 10 AU/mL; ULOQ= 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned mRNA-1273 vaccination in Part 3 open-label phase per schedule, received 3rd dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment, had no major protocol deviations, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. Since number of participants enrolled in Part 3 was substantially smaller than planned sample size required for immunogenicity hypothesis testing after Dose 2 of mRNA-1273 25 μg primary series and after a 3rd dose of mRNA-1273 25 μg, hypothesis testing was not performed. Study P301 group: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. N = participants evaluable for this endpoint.

End point type

Primary

End point timeframe

Third Dose-Day 29 P204/Day 57 P301

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: The endpoint is descriptive in nature.

End point values	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg	Part 3 (6-11 Years): BD mRNA-1273 25 µg
Number of subjects analysed	294	52
Units: AU/mL
geometric mean (confidence interval 95%)	1400.4 (1272.7 to 1541.0)	4616.6 (3669.4 to 5808.3)

No statistical analyses for this end point

Primary: Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

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End point title

Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

End point description

Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as change from below LLOQ to equal above 4 * LLOQ, or at least 4-fold rise if baseline is equal to or above LLOQ. LLOQ= 10 AU/mL; ULOQ= 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned mRNA-1273 vaccination in Part 1 open-label or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment, no major protocol deviations, and had not received off-study COVID-19 vaccine prior to BD-Day 29 visit. PP immunogenicity subset (Booster Dose Analysis). Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. ‘N’ = Pre-booster SARS-CoV-2 negative participants evaluable for this endpoint.

End point type

Primary

End point timeframe

BD-Day 29 P204/Day 57 P301

End point values	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg	BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg	BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg
Number of subjects analysed	294	72	129
Units: percentage of participants
number (confidence interval 95%)	99.3 (97.6 to 99.9)	100 (95.0 to 100.0)	100 (97.2 to 100.0)

Statistical Analysis 1

Statistical analysis description

Comparison groups

Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Phase Part 1 (6 Month-5 Yrs): PS mRNA-1273 25 μg - BD 10 μg

Number of subjects included in analysis

366

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

percentage difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

2.4

Statistical Analysis 2

Statistical analysis description

Comparison groups

Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg v BD Part 1 and 2 (6-11 Yrs): PS mRNA-1273 50 μg - BD 1273 25 μg

Number of subjects included in analysis

423

Analysis specification

Pre-specified

Analysis type

non-inferiority

Method

Parameter type

percentage difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

2.4

Primary: Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

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End point title

Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301 ^[9]

End point description

Percentage of participants with seroresponse for Pseudovirus Neutralizing Antibody VAC62 are reported. Seroresponse was defined as change from below LLOQ to equal above 4 * LLOQ, or at least a 4-fold rise if baseline is equal to or above LLOQ. LLOQ= 10 AU/mL; ULOQ= 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned mRNA-1273 vaccination in Part 3 open-label phase per schedule, received 3rd dose in Third Dose Analysis, not receiving HAART in participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. Study P301 mRNA-1273 100 μg: PPIS of randomly selected participants from study P301 aged 18-25 meeting pre-specified criteria. N= participants evaluable for this endpoint.

End point type

Primary

End point timeframe

Third Dose-Day 29 P204/Day 57 P301

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: The endpoint is descriptive in nature.

End point values	Study mRNA-1273-P301 (NCT04470427) mRNA-1273 100 μg	Part 3 (6-11 Years): BD mRNA-1273 25 µg
Number of subjects analysed	294	50
Units: percentage of participants
number (confidence interval 95%)	99.3 (97.6 to 99.9)	90.0 (78.2 to 96.7)

No statistical analyses for this end point

Secondary: Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57

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End point title

Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57 ^[10]

End point description

GM level of SARSCOV2S2P immunoglobulin G (IgG) antibody VAC123/VAC72, as measured by ECL multiplex assay specific to SARS-CoV-2 spike protein is reported. Antibody values reported as <LLOQ replaced by 0.5*LLOQ and values >ULOQ replaced by ULOQ if actual values were not available. LLOQ was 23 AU/mL and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 AU/mL and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset: all enrolled participants who received planned doses of study vaccine per schedule, had baseline SARS-CoV-2 status, had baseline and Day 57 antibody assessment, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations. Overall number of participants analyzed= participants evaluable for this endpoint. n= participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Day 1, Day 57 (1 month after Dose 2)

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): mRNA-1273 25 µg
Number of subjects analysed	200	56	50	68	96	308	304	285
Units: AU/mL
geometric mean (confidence interval 95%)
Baseline (Day 1) (n=200,56,50,68,96,294,304,285)	35.6 (31.0 to 40.8)	49.1 (33.9 to 71.1)	15.8 (13.5 to 18.5)	33.7 (26.2 to 43.4)	14.6 (12.8 to 16.7)	32.6 (28.5 to 37.3)	24.5 (21.7 to 27.5)	22.0 (19.1 to 25.3)
Day 57 (n=200,56,50, 61,95,308,301,280)	325784.0 (302917.7 to 350376.4)	457349.2 (402424.0 to 519770.8)	261952.0 (227935.8 to 301044.7)	417419.8 (359399.2 to 484807.0)	297561.7 (234740.9 to 377194.3)	293118.9 (261748.3 to 328249.4)	235059.2 (198610.2 to 278197.3)	293955.4 (256077.7 to 337435.8)

No statistical analyses for this end point

Secondary: Part 1 and Part 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29

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End point title

Part 1 and Part 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29

End point description

GM level of SARSCOV2S2P IgG antibody VAC123/VAC72 is reported. Antibody values reported as <LLOQ were replaced by 0.5*LLOQ and values >ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 23 and ULOQ was 14000000 AU/mL for VAC72. LLOQ was 69 and ULOQ was 14400000 AU/mL for VAC123. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned mRNA-1273 in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline, had BD-Day 29 antibody assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. Number analyzed = participants evaluable for this endpoint. n= participants evaluable at specified timepoint. ‘0.99 and 99999’ signifies data not available.

End point type

Secondary

End point timeframe

Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1 (Pre-booster), BD-Day 29 (1 month after booster dose)

End point values	Part 1 (6-11 Years): PS mRNA-1273 50 μg - BD 25 μg	Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg	Part 2 (6-11 Years): PS mRNA-1273 50 μg - BD 1273 25 μg
Number of subjects analysed	75	84	19	114
Units: AU/mL
geometric mean (confidence interval 95%)
Baseline (n=72,80,13,91)	50.0 (42.7 to 58.6)	37.5 (34.3 to 40.9)	34.5 (0.99 to 99999)	51.9 (44.6 to 60.3)
Day 57 (n=55,56,12,16)	302128.3 (266991.2 to 341889.7)	279427.6 (242953.8 to 321377.2)	241874.9 (180565.7 to 324001.0)	336189.6 (257789.9 to 438432.5)
Day 209 (n=45,69,19,111)	74516.9 (63553.5 to 87371.5)	66516.5 (59365.2 to 74529.2)	71427.5 (50801.5 to 100427.9)	85360.1 (71680.4 to 101650.5)
BD-Day 1 (n=75,77,19,114)	66677.7 (52382.4 to 84874.2)	68322.4 (53860.8 to 86667.0)	50621.5 (34112.1 to 75121.2)	86416.4 (72836.0 to 102528.9)
BD-Day 29 (n=75,84,19,113)	633999.7 (561311.4 to 716101.0)	675348.1 (584405.3 to 780443.0)	536478.9 (403508.2 to 713268.2)	520973.0 (469812.4 to 577704.8)

No statistical analyses for this end point

Secondary: Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

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End point title

Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

End point description

GM level of SARSCOV2S2P IgG antibody against B.1.1.529 strain is reported. Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 102 and ULOQ was 1180000 AU/mL for VAC123. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, participants with HIV were not receiving HAART, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impact key or critical data, and had not receive off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

End point values	Part 3 (6-11 Years): BD mRNA-1273 25 µg
Number of subjects analysed	52
Units: AU/mL
geometric mean (confidence interval 95%)
Baseline (Pre-dose 1) (n = 50)	4659.5 (2918.7 to 7438.5)
Day 57 (n = 50)	141758.0 (118762.4 to 169206.2)
Third Dose-Day 1 (n = 49)	48176.2 (38955.2 to 59580.0)
Third Dose-Day 29 (n = 52)	93436.4 (77735.5 to 112308.5)
Third Dose-Day 181 (n = 46)	40271.7 (32950.9 to 49219.2)

No statistical analyses for this end point

Secondary: Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57

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End point title

Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57 ^[11]

End point description

Antibody values reported as below LLOQ were replaced by 0.5*LLOQ and values greater than ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 18.5 AU/mL and ULOQ was 45118 AU/mL for ID50 titer. PP Immunogenicity Subset as defined in Endpoint 4 above. 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable at specified timepoint. 0.999 and 99999 signifies data not evaluable. Raw antibody values reported as below the LLOQ were replaced by 0.5 * LLOQ in analysis. All the antibody values in these sample were below the LLOQ and were imputed identically as the value of 0.5 * LLOQ in analysis, resulting in zero variability in these samples. As a result, while geometrical mean can be calculated, the confidence intervals cannot.

End point type

Secondary

End point timeframe

Day 1 and Day 57 (1 month after Dose 2)

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): mRNA-1273 50 µg
Number of subjects analysed	201	56	51	68	97	309
Units: titer
geometric mean (confidence interval 95%)
Day 1 (n=201,56,50,68,97,308)	9.3 (9.2 to 9.5)	9.6 (8.9 to 10.3)	9.3 (0.999 to 99999)	9.3 (0.999 to 99999)	9.6 (9.3 to 9.9)	9.3 (0.999 to 99999)
Day 57 (n=201,56,51,68,97,309)	1669.1 (1504.5 to 1851.6)	1890.2 (1603.8 to 2227.7)	1012.5 (848.2 to 1208.6)	1845.9 (1600.5 to 2128.9)	1782.6 (1542.0 to 2060.7)	1618.3 (1460.0 to 1793.9)

No statistical analyses for this end point

Secondary: Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57

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End point title

Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57 ^[12]

End point description

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. Data are reported per Baseline SARS-CoV-2 status: Negative and Positive. PP Immunogenicity Subset: all enrolled participants who received at least 1 injection of study drug, had baseline SARS-CoV-2 status, had baseline and at least 1 post-injection antibody assessment for analysis endpoint, complied with immunogenicity window based on 2nd injection timing; had negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline, not receiving HAART in participants with HIV; and had no major protocol deviations that impacted key or critical data. 'Overall number of participants analyzed' = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Day 1 and Day 57 (1 month after Dose 2)

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg
Number of subjects analysed	315	311	57
Units: AU/mL
geometric mean (confidence interval 95%)
Baseline SARS-CoV-2 (Negative): Day 1(n=315,311,4)	7.9 (7.5 to 8.4)	8.0 (7.5 to 8.5)	21.5 (2.6 to 175.1)
Baseline SARS-CoV-2 (Positive): Day 1 (n=28,19,57)	175.3 (130.4 to 235.6)	199.9 (109.2 to 365.9)	177.5 (111.2 to 283.3)
Baseline SARS-CoV-2(Negative): Day 57(n=298,278,4)	1398.1 (1271.9 to 1536.8)	1760.8 (1609.7 to 1926.0)	2140.6 (728.7 to 6288.7)
Baseline SARS-CoV-2 (Positive): Day 57(n=23,15,57)	7430.0 (5188.4 to 10640.1)	10411.6 (6712.1 to 16150.1)	4592.9 (3470.7 to 6077.9)

No statistical analyses for this end point

Secondary: Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29

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End point title

Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29

End point description

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Booster Dose Analysis): all enrolled participants who received 2 doses of planned doses of mRNA-1273 vaccination in Part 1 open-label phase or Part 2 blinded phase per schedule, received booster dose in Booster Dose Analysis, not receiving HAART in participants with HIV, had a negative SARS-CoV-2 status at baseline (pre-dose 1 of mRNA-1273), had BD-Day 29 Ab assessment for the analysis endpoint, no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Day 209 (6 months after Dose 2), BD-Day 1 (Pre-booster), and BD-Day 29 (1 month after booster dose or third dose)

End point values	Part 1 (6-11 Years): PS mRNA-1273 100 μg - BD 25 μg	Part 1 (6-23 Months): PS mRNA-1273 25 μg - BD 10 μg	Part 1 (2-5 Years): PS mRNA-1273 25 μg - BD 10 μg	Part 2(6-11 Yrs): PS Placebo - mRNA-1273 50 μg - BD 1273 25 μg
Number of subjects analysed	75	84	19	114
Units: AU/mL
geometric mean (confidence interval 95%)
Baseline (n=70,81,16,111)	9.3 (8.5 to 10.3)	9.0 (8.2 to 9.9)	12.8 (10.0 to 16.3)	7.8 (7.1 to 8.6)
Day 57 (n=55,56,18,18)	1503.3 (1292.3 to 1748.7)	1557.1 (1294.2 to 1873.5)	1275.0 (983.0 to 1653.8)	1718.7 (1316.5 to 2243.7)
Day 209 (n=45,68,18,110)	530.3 (432.5 to 650.2)	448.6 (376.9 to 533.8)	544.5 (343.1 to 864.0)	790.7 (633.8 to 986.4)
BD-Day 1 (n=75,75,18,113)	627.9 (467.8 to 842.8)	558.0 (408.5 to 762.2)	447.2 (270.0 to 740.7)	795.5 (640.8 to 987.5)
BD-Day 29 (n=75,84,19,114)	6991.6 (6091.2 to 8025.0)	6474.7 (5406.0 to 7754.8)	5778.7 (4039.7 to 8266.4)	5805.4 (5122.4 to 6579.4)

No statistical analyses for this end point

Secondary: Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181

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End point title

Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181

End point description

Antibody values reported as below the LLOQ were replaced by 0.5*LLOQ and values greater than the ULOQ were replaced by ULOQ if actual values were not available. LLOQ was 10 AU/mL and ULOQ was 111433 AU/mL. PP Immunogenicity Subset (Third Dose Analysis): all enrolled participants who received first 2 doses of planned doses of mRNA-1273 vaccination in Part 3 open-label phase per schedule, received third dose in Third Dose Analysis, not receiving HAART in participants with HIV, had BD-Day 29 antibody assessment for the analysis endpoint, had no major protocol deviations that impacted key or critical data, and had not received off-study COVID-19 vaccination prior to BD-Day 29 visit. ‘Overall number of participants analyzed’ = participants evaluable for this endpoint. n = participants evaluable at specified timepoint.

End point type

Secondary

End point timeframe

Baseline (Pre-Dose 1), Day 57 (1 month after Dose 2), Third Dose-Day 1 (at least 3 months or 6 months after Dose 2), Third Dose-Day 29 (1 month after third dose), and Third Dose-Day 181 (6 months after third dose)

End point values	Part 3 (6-11 Years): BD mRNA-1273 25 µg
Number of subjects analysed	52
Units: AU/mL
geometric mean (confidence interval 95%)
Baseline (n=50)	120.0 (71.9 to 200.3)
Day 57 (n=50)	3775.0 (2767.5 to 5149.3)
Third Dose-Day 1 (n=49)	1839.1 (1279.8 to 2643.0)
Third Dose-Day 29 (n=52)	4616.6 (3669.4 to 5808.3)
Third Dose-Day 181 (n=46)	1432.5 (1038.6 to 1975.8)

No statistical analyses for this end point

Secondary: Part 2: Number of Participants With SARS-CoV-2 infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR)

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End point title

Part 2: Number of Participants With SARS-CoV-2 infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR) ^[13]

End point description

SARS-CoV-2 infection was defined in participants with negative SARS-CoV-2 at baseline: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1, that became positive (as measured by Roche Elecsys) postbaseline; OR positive RT-PCR postbaseline. A summary of SAEs and all nonserious AEs ("Other") regardless of causality, is located in the Reported "Adverse Events" section. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

14 days after second injection

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg
Number of subjects analysed	849	2606	854	2592	563	1686
Units: participants	14	13	178	330	94	198

Statistical Analysis 1

Statistical analysis description

The 95% confidence interval (CI) of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years. Vaccine efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).

Comparison groups

Part 2 (6-11 Years): Placebo v Part 2 (6-11 Years): mRNA-1273 50 µg

Number of subjects included in analysis

3455

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.706

Confidence interval

level

95%

sides

2-sided

lower limit

0.325

upper limit

0.873

Statistical Analysis 3

Statistical analysis description

The 95% CI of the ratio was calculated using the exact method conditional upon the total number of cases, adjusting for person-years. Vaccine Efficacy (percent), was defined as 1 - ratio of incidence rate (mRNA-1273 vs. placebo).

Comparison groups

Part 2 (6-23 Months): Placebo v Part 2 (6-23 Months): mRNA-1273 25 µg

Number of subjects included in analysis

2249

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.324

Confidence interval

level

95%

sides

2-sided

lower limit

0.127

upper limit

0.474

Statistical Analysis 2

Statistical analysis description

Comparison groups

Part 2 (2-5 Years): Placebo v Part 2 (2-5 Years): mRNA-1273 25 µg

Number of subjects included in analysis

3446

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.409

Confidence interval

level

95%

sides

2-sided

lower limit

0.287

upper limit

0.509

Secondary: Part 2: Number of Participants With Asymptomatic SARS-CoV-2 infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys)

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End point title

Part 2: Number of Participants With Asymptomatic SARS-CoV-2 infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys) ^[14]

End point description

Asymptomatic SARS-CoV-2 infection was identified by absence of symptoms and infections as detected by RT-PCR or serology tests: Absence of COVID-19 symptoms AND at least 1 from following: bAb level against SARS-CoV-2 nucleocapsid protein negative at Day 1 that became positive post-baseline, OR positive RT-PCR test post-baseline. A summary of SAEs and all nonserious AEs ("Other") regardless of causality, is located in the Reported "Adverse Events" section. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

End point type

Secondary

End point timeframe

14 days after second injection

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg
Number of subjects analysed	849	2606	854	2592	563	1686
Units: participants	10	10	55	124	21	70

Statistical Analysis 1

Statistical analysis description

Comparison groups

Part 2 (6-11 Years): Placebo v Part 2 (6-11 Years): mRNA-1273 50 µg

Number of subjects included in analysis

3455

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.683

Confidence interval

level

95%

sides

2-sided

lower limit

0.151

upper limit

0.882

Statistical Analysis 2

Statistical analysis description

Comparison groups

Part 2 (2-5 Years): Placebo v Part 2 (2-5 Years): mRNA-1273 25 µg

Number of subjects included in analysis

3446

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.281

Confidence interval

level

95%

sides

2-sided

lower limit

-0.007

upper limit

0.48

Statistical Analysis 3

Statistical analysis description

Comparison groups

Part 2 (6-23 Months): Placebo v Part 2 (6-23 Months): mRNA-1273 25 µg

Number of subjects included in analysis

2249

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

-0.068

Confidence interval

level

95%

sides

2-sided

lower limit

-0.832

upper limit

0.352

Secondary: Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19)

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End point title

Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19) ^[15]

End point description

A COVID-19 case was identified as a positive post-baseline RT-PCR test result together with at least 1 of following systemic symptoms: fever (≥ 38 degrees Celsius [°C]/≥ 100.4 degree Fahrenheit [°F]) or chills, fatigue, headache, myalgia, nasal congestion or rhinorrhea, new loss of taste or smell, sore throat, abdominal pain, diarrhoea, nausea/vomiting, poor appetite/poor feeding; or at least 1 of following respiratory signs/symptoms: cough, shortness of breath or difficulty breathing. A summary of SAEs and all nonserious AEs ("Other") regardless of causality, is located in the Reported "Adverse Events" section. PP Set for Efficacy included all enrolled participants who received planned doses of study drug per schedule, complied with the 2nd injection timing, had no major protocol deviations that impacted key or critical efficacy data, and had a negative RT-PCR test for SARS-CoV-2 and negative serology test based on bAb specific to SARS-CoV-2 nucleocapsid protein at baseline.

End point type

Secondary

End point timeframe

14 days after second injection

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg
Number of subjects analysed	849	2606	854	2592	563	1686
Units: participants	4	3	125	207	73	130

Statistical Analysis 1

Statistical analysis description

Comparison groups

Part 2 (6-11 Years): Placebo v Part 2 (6-11 Years): mRNA-1273 50 µg

Number of subjects included in analysis

3455

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

-0.416

upper limit

0.965

Statistical Analysis 2

Statistical analysis description

Comparison groups

Part 2 (2-5 Years): Placebo v Part 2 (2-5 Years): mRNA-1273 25 µg

Number of subjects included in analysis

3446

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.466

Confidence interval

level

95%

sides

2-sided

lower limit

0.328

upper limit

0.574

Statistical Analysis 3

Statistical analysis description

Comparison groups

Part 2 (6-23 Months): Placebo v Part 2 (6-23 Months): mRNA-1273 25 µg

Number of subjects included in analysis

2249

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Vaccine Efficacy

Point estimate

0.432

Confidence interval

level

95%

sides

2-sided

lower limit

0.232

upper limit

0.576

Other pre-specified: Number of Deaths Related to Study Drug

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End point title

Number of Deaths Related to Study Drug ^[16]

End point description

A death that occurred during the study or that came to the attention of investigator during study was reported to Sponsor, whether or not it was considered related to study drug. Investigator assessed causality. Not related: There was not a reasonable possibility of a relationship to study drug. The temporal sequence of death relative to administration of study drug was not reasonable AND/OR the death was more likely explained by a cause other than study drug. Related: There was a reasonable possibility of a relationship to study drug. There was evidence of exposure to study drug. The temporal sequence of death relative to administration of study drug was reasonable. Death was more likely explained by study drug than by another cause. Safety Set of Part 1 and Part 3 included all dosed participants and of Part 2 included all randomized participants who received any study injection. Data are reported by study part and by age categories of "6-11 years" and "6 months-5 years".

End point type

Other pre-specified

End point timeframe

Up to 2 years

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: The endpoint is descriptive in nature.

End point values	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-23 Months): mRNA-1273 25 µg	Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)	Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)	Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)	Part 3 (6-11 Years): BD mRNA-1273 25 µg	6-11 Years: BD mRNA-1273 25 μg	6-11 Yrs: BD mRNA-1273.214 25 μg	6 Months-5 Yrs: BD mRNA-1273 10 μg	6 Months-5 Yrs: BD mRNA-1273 25 μg	6 Months-5 Yrs: BD mRNA-1273.214 10 μg	6 Months-5 Yrs: BD mRNA-1273.214 25 μg
Number of subjects analysed	380	371	69	150	995	3007	1007	3031	666	1994	90	155	701	640	444	70	2766	184	212	89	2771	28
Units: participants
Deaths	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Deaths related to study drug	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Up to 2 years

Adverse event reporting additional description

Safety Set of Parts 1 & 3: dosed participants; of Part 2: randomized participants receiving study drug. Nonserious SARs persisting >7 days, leading to discontinuation or medically attended not considered AEs unless serious. COVID-19/SARS-CoV-2 infections considered clinical events for efficacy not AEs.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

Part 1 (6-11 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (6-11 Years): mRNA-1273 100 µg

Reporting group description

Participants received 2 doses of 100 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (2-5 Years): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (2-5 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (6-23 Months): Placebo

Reporting group description

Reporting group title

Part 2 (6-11 Years): Placebo

Reporting group description

Reporting group title

Part 2 (6-11 Years): mRNA-1273 50 µg

Reporting group description

Participants received 2 doses of 50 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (2-5 Years): Placebo

Reporting group description

Reporting group title

Part 2 (2-5 Years): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 1 (6-23 Months): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

Part 2 (6-23 Months): mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1 and Day 29).

Reporting group title

6 Months-5 Yrs: BD mRNA-1273 25 μg

Reporting group description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Reporting group title

Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg

Reporting group description

Participants received 2 doses of 25 µg mRNA-1273 by IM injection approximately 28 days apart (Day 1, and Day 29).

Reporting group title

Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)

Reporting group description

Participants received a placebo in the blinded phase and then crossover vaccination with 50 μg of mRNA-1273 after the availability of a COVID-19 vaccine under EUA.

Reporting group title

Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)

Reporting group description

Reporting group title

Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)

Reporting group description

Reporting group title

Part 3 (6-11 Years): BD mRNA-1273 25 µg

Reporting group description

Participants received a third dose of 25 µg mRNA-1273 by IM injection on Day 149.

Reporting group title

6-11 Years: BD mRNA-1273 25 μg

Reporting group description

Participants received a single dose of 25 μg mRNA-1273 by IM injection on BD-Day 1.

Reporting group title

6-11 Yrs: BD mRNA-1273.214 25 μg

Reporting group description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Reporting group title

6 Months-5 Yrs: BD mRNA-1273 10 μg

Reporting group description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Reporting group title

6 Months-5 Yrs: BD mRNA-1273.214 10 μg

Reporting group description

Participants received a single dose of 10 μg mRNA-1273 by IM injection on BD-Day 1.

Reporting group title

6 Months-5 Yrs: BD mRNA-1273.214 25 μg

Reporting group description

Participants received a single dose of 25 μg mRNA-1273.214 by IM injection on BD-Day 1.

Part 1 (6-11 Years): mRNA-1273 50 µg

Part 1 (6-11 Years): mRNA-1273 100 µg

Part 1 (2-5 Years): mRNA-1273 25 µg

Part 1 (2-5 Years): mRNA-1273 50 µg

Part 2 (6-23 Months): Placebo

Part 2 (6-11 Years): Placebo

Part 2 (6-11 Years): mRNA-1273 50 µg

Part 2 (2-5 Years): Placebo

Part 2 (2-5 Years): mRNA-1273 25 µg

Part 1 (6-23 Months): mRNA-1273 25 µg

Part 2 (6-23 Months): mRNA-1273 25 µg

6 Months-5 Yrs: BD mRNA-1273 25 μg

Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg

Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)

Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)

Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)

Part 3 (6-11 Years): BD mRNA-1273 25 µg

6-11 Years: BD mRNA-1273 25 μg

6-11 Yrs: BD mRNA-1273.214 25 μg

6 Months-5 Yrs: BD mRNA-1273 10 μg

6 Months-5 Yrs: BD mRNA-1273.214 10 μg

6 Months-5 Yrs: BD mRNA-1273.214 25 μg

Total subjects affected by serious adverse events

subjects affected / exposed

5 / 380 (1.32%)

3 / 371 (0.81%)

0 / 69 (0.00%)

0 / 155 (0.00%)

7 / 666 (1.05%)

1 / 995 (0.10%)

22 / 3007 (0.73%)

3 / 1007 (0.30%)

32 / 3031 (1.06%)

3 / 150 (2.00%)

45 / 1994 (2.26%)

1 / 89 (1.12%)

1 / 90 (1.11%)

3 / 701 (0.43%)

8 / 640 (1.25%)

4 / 444 (0.90%)

0 / 70 (0.00%)

12 / 2766 (0.43%)

0 / 184 (0.00%)

1 / 212 (0.47%)

23 / 2771 (0.83%)

0 / 28 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Vascular disorders

Kawasaki's disease

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Pyrexia

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Systemic inflammatory response syndrome

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

1 / 1007 (0.10%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune system disorders

Anaphylactic reaction

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

1 / 150 (0.67%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

Adnexal torsion

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Acute respiratory distress syndrome

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Acute respiratory failure

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

2 / 666 (0.30%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

2 / 1994 (0.10%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

1 / 444 (0.23%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Asthma

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

1 / 1007 (0.10%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

3 / 1994 (0.15%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchial hyperreactivity

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchospasm

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

1 / 90 (1.11%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dyspnoea

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoxia

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

1 / 666 (0.15%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory distress

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory failure

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Status asthmaticus

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

2 / 1994 (0.10%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Wheezing

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchiectasis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory symptom

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Disruptive mood dysregulation disorder

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Suicidal ideation

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oppositional defiant disorder

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Anxiety

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

1 / 701 (0.14%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Aggression

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mental status changes

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Foreign body ingestion

subjects affected / exposed

1 / 380 (0.26%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epiphyseal fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Foreign body in respiratory tract

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Greenstick fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Humerus fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skull fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tibia fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Torus fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Radius fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ulna fracture

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Scrotal haematoma

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Congenital, familial and genetic disorders

Congenital hydronephrosis

subjects affected / exposed

1 / 380 (0.26%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Bradycardia

subjects affected / exposed

0 / 380 (0.00%)

1 / 371 (0.27%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardio-respiratory arrest

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Nervous system disorders

Febrile convulsion

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

1 / 150 (0.67%)

3 / 1994 (0.15%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

1 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epilepsy

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Petit mal epilepsy

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Seizure

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Benign rolandic epilepsy

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Generalised tonic-clonic seizure

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Partial seizures

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Status epilepticus

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Bone marrow failure

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lymphadenitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neutropenia

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Optic disc drusen

subjects affected / exposed

1 / 380 (0.26%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain

subjects affected / exposed

0 / 380 (0.00%)

1 / 371 (0.27%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

2 / 2766 (0.07%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Constipation

subjects affected / exposed

0 / 380 (0.00%)

1 / 371 (0.27%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

1 / 89 (1.12%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis acute

subjects affected / exposed

0 / 380 (0.00%)

1 / 371 (0.27%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal discomfort

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastritis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ileus

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

1 / 701 (0.14%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intussusception

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Small intestinal obstruction

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Cholecystitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatitis acute

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Dermatomyositis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Erythema multiforme

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Synovitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Arthritis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

1 / 444 (0.23%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Adenovirus infection

subjects affected / exposed

0 / 380 (0.00%)

1 / 371 (0.27%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

2 / 1994 (0.10%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Rhinovirus infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

1 / 666 (0.15%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

1 / 1007 (0.10%)

2 / 3031 (0.07%)

1 / 150 (0.67%)

3 / 1994 (0.15%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

2 / 2766 (0.07%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 1

0 / 4

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Appendicitis

subjects affected / exposed

2 / 380 (0.53%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

4 / 3007 (0.13%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

1 / 701 (0.14%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

2 / 2766 (0.07%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 4

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Abdominal wall abscess

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

1 / 1007 (0.10%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abscess

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bronchiolitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

4 / 666 (0.60%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

8 / 1994 (0.40%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

1 / 444 (0.23%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

2 / 2771 (0.07%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

0 / 1

0 / 0

0 / 9

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis orbital

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Epstein-Barr virus infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Croup infectious

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

1 / 666 (0.15%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

2 / 1994 (0.10%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Escherichia sepsis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis salmonella

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis viral

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

2 / 1994 (0.10%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infectious pleural effusion

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Mastoiditis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Meningitis aseptic

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metapneumovirus infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

2 / 1994 (0.10%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Otitis media acute

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

2 / 2771 (0.07%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Parainfluenzae virus infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

2 / 3007 (0.07%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

3 / 1994 (0.15%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

5 / 2771 (0.18%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 5

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia bacterial

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia respiratory syncytial viral

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia viral

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyelonephritis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory syncytial virus bronchiolitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

2 / 1994 (0.10%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory syncytial virus infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

2 / 3031 (0.07%)

0 / 150 (0.00%)

3 / 1994 (0.15%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

2 / 640 (0.31%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

2 / 2771 (0.07%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 3

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory tract infection viral

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subperiosteal abscess

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tonsillitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urosepsis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Meningitis enteroviral

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

1 / 444 (0.23%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal viral infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Influenza

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

2 / 2766 (0.07%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Pharyngeal abscess

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

1 / 212 (0.47%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia pseudomonal

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Sinusitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

1 / 2766 (0.04%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Staphylococcal abscess

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Streptococcal infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

1 / 212 (0.47%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tracheitis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper respiratory tract infection

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

1 / 2771 (0.04%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Diabetic ketoacidosis

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Electrolyte imbalance

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Type 1 diabetes mellitus

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

1 / 3007 (0.03%)

0 / 1007 (0.00%)

1 / 3031 (0.03%)

0 / 150 (0.00%)

1 / 1994 (0.05%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

0 / 640 (0.00%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dehydration

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

2 / 640 (0.31%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hypophagia

subjects affected / exposed

0 / 380 (0.00%)

0 / 371 (0.00%)

0 / 69 (0.00%)

0 / 155 (0.00%)

0 / 666 (0.00%)

0 / 995 (0.00%)

0 / 3007 (0.00%)

0 / 1007 (0.00%)

0 / 3031 (0.00%)

0 / 150 (0.00%)

0 / 1994 (0.00%)

0 / 89 (0.00%)

0 / 90 (0.00%)

0 / 701 (0.00%)

1 / 640 (0.16%)

0 / 444 (0.00%)

0 / 70 (0.00%)

0 / 2766 (0.00%)

0 / 184 (0.00%)

0 / 212 (0.00%)

0 / 2771 (0.00%)

0 / 28 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Part 1 (6-11 Years): mRNA-1273 50 µg	Part 1 (6-11 Years): mRNA-1273 100 µg	Part 1 (2-5 Years): mRNA-1273 25 µg	Part 1 (2-5 Years): mRNA-1273 50 µg	Part 2 (6-23 Months): Placebo	Part 2 (6-11 Years): Placebo	Part 2 (6-11 Years): mRNA-1273 50 µg	Part 2 (2-5 Years): Placebo	Part 2 (2-5 Years): mRNA-1273 25 µg	Part 1 (6-23 Months): mRNA-1273 25 µg	Part 2 (6-23 Months): mRNA-1273 25 µg	6 Months-5 Yrs: BD mRNA-1273 25 μg	Part 3 (6-11 Years): Primary Series mRNA-1273 25 µg	Part 2(6-11 Yrs): PS PBO - mRNA-1273 50 μg (Crossover)	Part 2 (2-5 Years): PS PBO - mRNA-1273 25 μg (Crossover)	Part 2 (6-23 Months): PBO - mRNA-1273 25 μg (Crossover)	Part 3 (6-11 Years): BD mRNA-1273 25 µg	6-11 Years: BD mRNA-1273 25 μg	6-11 Yrs: BD mRNA-1273.214 25 μg	6 Months-5 Yrs: BD mRNA-1273 10 μg	6 Months-5 Yrs: BD mRNA-1273.214 10 μg	6 Months-5 Yrs: BD mRNA-1273.214 25 μg
Total subjects affected by non serious adverse events
subjects affected / exposed	145 / 380 (38.16%)	134 / 371 (36.12%)	30 / 69 (43.48%)	78 / 155 (50.32%)	317 / 666 (47.60%)	100 / 995 (10.05%)	573 / 3007 (19.06%)	356 / 1007 (35.35%)	1341 / 3031 (44.24%)	111 / 150 (74.00%)	1095 / 1994 (54.91%)	20 / 89 (22.47%)	9 / 90 (10.00%)	64 / 701 (9.13%)	58 / 640 (9.06%)	62 / 444 (13.96%)	4 / 70 (5.71%)	468 / 2766 (16.92%)	28 / 184 (15.22%)	56 / 212 (26.42%)	655 / 2771 (23.64%)	4 / 28 (14.29%)
General disorders and administration site conditions
Fatigue
subjects affected / exposed	10 / 380 (2.63%)	10 / 371 (2.70%)	0 / 69 (0.00%)	1 / 155 (0.65%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	9 / 150 (6.00%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	10	11	0	1	0	0	0	0	0	11	0	0	0	0	0	0	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	17 / 380 (4.47%)	21 / 371 (5.66%)	2 / 69 (2.90%)	23 / 155 (14.84%)	57 / 666 (8.56%)	10 / 995 (1.01%)	83 / 3007 (2.76%)	49 / 1007 (4.87%)	222 / 3031 (7.32%)	40 / 150 (26.67%)	194 / 1994 (9.73%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	17	26	2	29	70	11	89	58	269	58	224	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Vomiting
subjects affected / exposed	11 / 380 (2.89%)	6 / 371 (1.62%)	1 / 69 (1.45%)	6 / 155 (3.87%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	12 / 150 (8.00%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	11	6	1	6	0	0	0	0	0	12	0	0	0	0	0	0	0	0	0	0	0	0
Teething
subjects affected / exposed	0 / 380 (0.00%)	0 / 371 (0.00%)	0 / 69 (0.00%)	0 / 155 (0.00%)	39 / 666 (5.86%)	0 / 995 (0.00%)	1 / 3007 (0.03%)	7 / 1007 (0.70%)	9 / 3031 (0.30%)	15 / 150 (10.00%)	109 / 1994 (5.47%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	0	0	43	0	1	7	9	17	131	0	0	0	0	0	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	6 / 380 (1.58%)	7 / 371 (1.89%)	2 / 69 (2.90%)	4 / 155 (2.58%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	9 / 150 (6.00%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	6	7	2	4	0	0	0	0	0	12	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	23 / 380 (6.05%)	34 / 371 (9.16%)	8 / 69 (11.59%)	12 / 155 (7.74%)	43 / 666 (6.46%)	26 / 995 (2.61%)	136 / 3007 (4.52%)	69 / 1007 (6.85%)	262 / 3031 (8.64%)	27 / 150 (18.00%)	130 / 1994 (6.52%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	25	40	9	14	54	30	148	90	351	42	161	0	0	0	0	0	0	0	0	0	0	0
Nasal congestion
subjects affected / exposed	27 / 380 (7.11%)	34 / 371 (9.16%)	5 / 69 (7.25%)	5 / 155 (3.23%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	18 / 150 (12.00%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	28	45	6	5	0	0	0	0	0	27	0	0	0	0	0	0	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	20 / 380 (5.26%)	24 / 371 (6.47%)	2 / 69 (2.90%)	4 / 155 (2.58%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	1 / 150 (0.67%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	20	32	2	4	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	12 / 380 (3.16%)	26 / 371 (7.01%)	6 / 69 (8.70%)	13 / 155 (8.39%)	53 / 666 (7.96%)	28 / 995 (2.81%)	107 / 3007 (3.56%)	70 / 1007 (6.95%)	250 / 3031 (8.25%)	34 / 150 (22.67%)	173 / 1994 (8.68%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	12	31	6	16	70	30	125	87	310	53	222	0	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders
Attention deficit hyperactivity disorder
subjects affected / exposed	0 / 380 (0.00%)	0 / 371 (0.00%)	0 / 69 (0.00%)	0 / 155 (0.00%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	0 / 150 (0.00%)	0 / 1994 (0.00%)	3 / 89 (3.37%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	44 / 2766 (1.59%)	1 / 184 (0.54%)	1 / 212 (0.47%)	10 / 2771 (0.36%)	2 / 28 (7.14%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	44	1	1	10	2
Infections and infestations
Croup infectious
subjects affected / exposed	2 / 380 (0.53%)	5 / 371 (1.35%)	1 / 69 (1.45%)	2 / 155 (1.29%)	15 / 666 (2.25%)	2 / 995 (0.20%)	17 / 3007 (0.57%)	16 / 1007 (1.59%)	96 / 3031 (3.17%)	10 / 150 (6.67%)	104 / 1994 (5.22%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	2	5	1	2	16	2	18	19	107	10	124	0	0	0	0	0	0	0	0	0	0	0
Otitis media acute
subjects affected / exposed	0 / 380 (0.00%)	3 / 371 (0.81%)	1 / 69 (1.45%)	2 / 155 (1.29%)	18 / 666 (2.70%)	1 / 995 (0.10%)	12 / 3007 (0.40%)	16 / 1007 (1.59%)	84 / 3031 (2.77%)	15 / 150 (10.00%)	113 / 1994 (5.67%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	3	1	2	24	1	12	19	103	29	154	0	0	0	0	0	0	0	0	0	0	0
Otitis media
subjects affected / exposed	5 / 380 (1.32%)	1 / 371 (0.27%)	3 / 69 (4.35%)	7 / 155 (4.52%)	54 / 666 (8.11%)	2 / 995 (0.20%)	31 / 3007 (1.03%)	42 / 1007 (4.17%)	231 / 3031 (7.62%)	24 / 150 (16.00%)	258 / 1994 (12.94%)	5 / 89 (5.62%)	0 / 90 (0.00%)	5 / 701 (0.71%)	23 / 640 (3.59%)	38 / 444 (8.56%)	0 / 70 (0.00%)	46 / 2766 (1.66%)	1 / 184 (0.54%)	16 / 212 (7.55%)	225 / 2771 (8.12%)	1 / 28 (3.57%)
occurrences all number	5	2	3	9	73	2	35	52	280	38	385	5	0	5	28	45	0	48	1	22	258	2
Hand-foot-and-mouth disease
subjects affected / exposed	0 / 380 (0.00%)	0 / 371 (0.00%)	1 / 69 (1.45%)	3 / 155 (1.94%)	22 / 666 (3.30%)	0 / 995 (0.00%)	8 / 3007 (0.27%)	10 / 1007 (0.99%)	60 / 3031 (1.98%)	14 / 150 (9.33%)	114 / 1994 (5.72%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	0	0	1	3	22	0	8	10	63	14	122	0	0	0	0	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	1 / 380 (0.26%)	9 / 371 (2.43%)	4 / 69 (5.80%)	3 / 155 (1.94%)	64 / 666 (9.61%)	3 / 995 (0.30%)	22 / 3007 (0.73%)	47 / 1007 (4.67%)	237 / 3031 (7.82%)	19 / 150 (12.67%)	249 / 1994 (12.49%)	3 / 89 (3.37%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	37 / 2766 (1.34%)	2 / 184 (1.09%)	10 / 212 (4.72%)	141 / 2771 (5.09%)	2 / 28 (7.14%)
occurrences all number	1	9	4	6	95	3	22	64	291	25	353	4	0	0	0	0	0	38	2	13	163	2
Respiratory tract infection viral
subjects affected / exposed	25 / 380 (6.58%)	0 / 371 (0.00%)	0 / 69 (0.00%)	5 / 155 (3.23%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	0 / 150 (0.00%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	31	0	0	7	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	4 / 380 (1.05%)	8 / 371 (2.16%)	2 / 69 (2.90%)	4 / 155 (2.58%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	8 / 150 (5.33%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	4	8	2	4	0	0	0	0	0	8	0	0	0	0	0	0	0	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	56 / 380 (14.74%)	50 / 371 (13.48%)	9 / 69 (13.04%)	45 / 155 (29.03%)	146 / 666 (21.92%)	47 / 995 (4.72%)	284 / 3007 (9.44%)	190 / 1007 (18.87%)	630 / 3031 (20.79%)	37 / 150 (24.67%)	512 / 1994 (25.68%)	6 / 89 (6.74%)	9 / 90 (10.00%)	59 / 701 (8.42%)	39 / 640 (6.09%)	31 / 444 (6.98%)	4 / 70 (5.71%)	164 / 2766 (5.93%)	2 / 184 (1.09%)	24 / 212 (11.32%)	132 / 2771 (4.76%)	0 / 28 (0.00%)
occurrences all number	87	75	11	81	218	49	370	262	926	70	805	6	11	64	46	46	8	205	2	35	142	0
Viral upper respiratory tract infection
subjects affected / exposed	11 / 380 (2.89%)	12 / 371 (3.23%)	4 / 69 (5.80%)	12 / 155 (7.74%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	9 / 150 (6.00%)	0 / 1994 (0.00%)	0 / 89 (0.00%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	0 / 2766 (0.00%)	0 / 184 (0.00%)	0 / 212 (0.00%)	0 / 2771 (0.00%)	0 / 28 (0.00%)
occurrences all number	14	15	4	13	0	0	0	0	0	14	0	0	0	0	0	0	0	0	0	0	0	0
Influenza
subjects affected / exposed	0 / 380 (0.00%)	0 / 371 (0.00%)	0 / 69 (0.00%)	0 / 155 (0.00%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	0 / 150 (0.00%)	0 / 1994 (0.00%)	3 / 89 (3.37%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	132 / 2766 (4.77%)	18 / 184 (9.78%)	6 / 212 (2.83%)	102 / 2771 (3.68%)	1 / 28 (3.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	135	18	7	106	1
Pharyngitis streptococcal
subjects affected / exposed	0 / 380 (0.00%)	0 / 371 (0.00%)	0 / 69 (0.00%)	0 / 155 (0.00%)	0 / 666 (0.00%)	0 / 995 (0.00%)	0 / 3007 (0.00%)	0 / 1007 (0.00%)	0 / 3031 (0.00%)	0 / 150 (0.00%)	0 / 1994 (0.00%)	5 / 89 (5.62%)	0 / 90 (0.00%)	0 / 701 (0.00%)	0 / 640 (0.00%)	0 / 444 (0.00%)	0 / 70 (0.00%)	134 / 2766 (4.84%)	10 / 184 (5.43%)	12 / 212 (5.66%)	190 / 2771 (6.86%)	1 / 28 (3.57%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	5	0	0	0	0	0	151	12	17	215	2

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Were there any global substantial amendments to the protocol? Yes

30 Apr 2021

- To allow a Data Safety Monitoring Board (DSMB) safety review when approximately 375 children have received mRNA-1273 in each age group, before expanding enrollment to each full age cohort in Part 2.

17 Jun 2021

- To add an optional blood collection on Day 57 for participants in the expansion part of Arm 1 and Arm 2 to gather additional data on immunogenicity. - To integrate the decision in Part 1 to not evaluate the 100 μg dose in participants less than 2 years by removing Arm 7 (6 to 23 months, 100 μg dose) from this age group. - To maintain dose ranging in the 2 to 5 years age group by allowing Arm 7 enrollment of participants in this age group to evaluate the 25 μg dose.

23 Jul 2021

- To add a case definition for myocarditis and pericarditis as well as guidance for reporting and assessing suspected cases for this study, given the recent emergence of a temporal association between mRNA vaccine administration and signs and symptoms of myocarditis/pericarditis. - To increase, the sample size for each age group in Part 2 (blinded part) to allow for a 95% probability to detect a rare AE occurring at a rate of 1 in 1000.

25 Aug 2021

- To introduce an additional blood draw within 4 days after the second dose for participants in Cohort D (phlebotomy cohort) in Part 2 in each age group (optional if already enrolled). The samples were stored for potential future analysis per a request from the Food and Drug Administration (FDA).

29 Sep 2021

- To simplify the process for potential crossover vaccination given the increased sample size of the study and to ensure retention in the study for safety follow-up. - To align with the Cardiac Event Adjudication Committee (CEAC) charter, and to clarify the DSMB safety data review process for the younger age groups (2 to 5 years; 6 to 23 months) to match the process in the older age group (6 to 11 years) and allow DSMB review of Part 1 (Open-label Phase) data before start of Part 2 (Blinded Phase) for the younger age groups.

07 Jan 2022

- To add an additional part to the study (Part 3) aimed at studying the safety, tolerability, reactogenicity, and immunogenicity of a lower dose level and regimen for 6 to 11-year-old children. - Addition of an Open-label Study Arm 14 for this age group with a sample size of approximately 300 participants who will receive two doses of 25 μg one month apart followed by a booster at least 3 months after the second dose.

18 Feb 2022

- To introduce an optional booster dose of mRNA-1273 for all participants in Part 1 (all age groups) and for the 6 to 11 years age group in Part 2 of the study. - Dosage levels are determined by age at booster dose: 25 μg for 6 to 11 years, 10 μg for 6 months to 5 years, regardless of primary series dosage level. - Interval of the booster dose is at least 6 months after Dose 2 of the primary series. - Safety follow-up is 12 months after the booster dose.

23 May 2022

- To unblind recipients receiving placebo who are under 6 years of age 6 months following their second vaccine dose so that they could be provided the option of receiving the crossover vaccine.

04 Aug 2022

- To provide an optional booster dose with mRNA-1273.214, a bivalent (Omicron containing) adaptation of the original COVID-19 vaccine (mRNA-1273) used in this study, at least 3 months after Dose 2 to all participants who had not received a booster dose after their primary series with mRNA-1273. - To remove COVID-19 surveillance for all parts of the study.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

Primary: Parts 1, 2, and 3: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

Primary: Parts 1, 2, and 3: Number of Participants With Unsolicited AEs

Primary: Parts 1, 2, and 3: Number of Participants With Unsolicited AEs

Primary: Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study

Primary: Parts 1, 2, and 3: Number of Participants With Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), Medically Attended AEs (MAAEs), and AEs Leading to Discontinuation From Study

Primary: Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 1 and 2: Geometric Mean (GM) Value of Serum Pseudovirus Neutralizing Antibody ID50 Titers From Study mRNA-1273-P204 (P204) Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 2 and 3: GM Concentration of Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 1 and 2: Seroresponse rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 1 and 2: Seroresponse rate (SRR) For Serum Pseudovirus Neutralizing Antibody ID50 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 2 and 3: SRR For Serum Pseudovirus Neutralizing Antibody VAC62 From Study P204 Vaccine Recipients at Day 57 Compared With Those From Young Adult (18 to 25 Years of Age) Vaccine Recipients (Day 57) in Study P301

Primary: Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301

Primary: Parts 1 and 2: GM Concentration of Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years of Age) Vaccine Recipients in Study P301

Primary: Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

Primary: Part 3: GM Concentration of Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 in Study P204 Compared With Post-primary Series (Post-Dose 2) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

Primary: Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

Primary: Parts 1 and 2: SRR for Post-booster Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

Primary: Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

Primary: Part 3: SRR for Post-third Dose Serum Pseudovirus Neutralizing Antibody VAC62 From Baseline (Pre-Dose 1) Compared With Post-primary Series (Post-Dose 2) From Baseline (Pre-Dose 1) in Young Adult (18 to 25 Years) Vaccine Recipients in Study P301

Secondary: Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57

Secondary: Parts 1 and 2: GM Level of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) S Protein-specific Binding Antibody (bAb), as Measured by MesoScale Discovery (MSD) Electrochemiluminescence (ECL) Multiplex Assay on Days 1 and 57

Secondary: Part 1 and Part 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29

Secondary: Part 1 and Part 2: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Day 209, BD-Day 1, and BD-Day 29

Secondary: Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

Secondary: Part 3: GM Level of SARS-CoV-2 S Protein-specific bAb, as Measured by MSD ECL Multiplex Assay on Baseline (Pre-dose 1), Day 57, Third Dose-Day 1, Third Dose-Day 29, Third Dose-Day 181

Secondary: Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57

Secondary: Parts 1 and 2: GM Value of SARS-CoV-2-specific Neutralizing Antibody ID50 Titers on Day 1 and Day 57

Secondary: Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57

Secondary: Parts 2 and 3: GM Concentration of SARS-CoV-2-specific Neutralizing Antibody VAC62 on Day 1 and Day 57

Secondary: Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29

Secondary: Parts 1 and 2: GM Concentration of Post-booster SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Day 209, BD-Day 1, and BD-Day 29

Secondary: Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181

Secondary: Part 3: GM Concentration of Post-third Dose SARS-CoV-2-specific Neutralizing Antibody VAC62 on Baseline, Day 57, Third Dose-Day 1, Third Dose-Day 29, and Third Dose-Day 181

Secondary: Part 2: Number of Participants With SARS-CoV-2 infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR)

Secondary: Part 2: Number of Participants With SARS-CoV-2 infection Including Symptomatic and Asymptomatic Infection (by Serology and/or RT-PCR)

Secondary: Part 2: Number of Participants With Asymptomatic SARS-CoV-2 infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys)

Secondary: Part 2: Number of Participants With Asymptomatic SARS-CoV-2 infection, Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein (by Roche Elecsys)

Secondary: Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19)

Secondary: Part 2: Number of Participants With Occurrence of COVID-19 (Per US Centers for Disease Control and Prevention [CDC] Case Definition of COVID-19)

Other pre-specified: Number of Deaths Related to Study Drug

Other pre-specified: Number of Deaths Related to Study Drug

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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