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Clinical Trial Results:
A phase 2b, open-label study to evaluate the safety, tolerability, and immunogenicity of vaccine candidate BNT162b2 in immunocompromised participants >=2 years of age.

Summary
EudraCT number	2021-001290-23
Trial protocol	DE
Global end of trial date	23 Jul 2023

Results information
Results version number	v1(current)
This version publication date	07 Feb 2024
First version publication date	07 Feb 2024
Other versions

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

C4591024

ISRCTN number

US NCT number

NCT04895982

WHO universal trial number (UTN)

Sponsor organisation name

BioNTech SE

Sponsor organisation address

An der Goldgrube 12, Mainz, Germany, 55131

Public contact

BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de

Scientific contact

BioNTech clinical trials patient information, BioNTech SE, +49 6131 90840, patients@biontech.de

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

Yes

EMA paediatric investigation plan number(s)

EMEA-002861-PIP02-20

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

09 Aug 2023

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

23 Jul 2023

Was the trial ended prematurely?

Main objective of the trial

The main objective of this study was to describe the safety, tolerability and immune response to prophylactic BNT162b2 in immunocompromised subjects >=2 to >=18 years of age without serological or virological evidence of past Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‑CoV‑2) infection and with representative medical conditions. Representative conditions for subjects >=18 years of age included non-small cell lung cancer (NSCLC), chronic lymphocytic leukemia (CLL), haemodialysis treatment secondary to end-stage renal disease, or immunomodulator therapy for an autoimmune inflammatory disorder. Representative conditions for subjects >=2 to <18 years of age included those with autoimmune inflammatory disorders receiving immunomodulators, those who had undergone organ transplant and were receiving maintenance antirejection modulators, and those who had undergone bone marrow or stem cell transplant.

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Oct 2021

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Germany: 46

Country: Number of subjects enrolled

Brazil: 25

Country: Number of subjects enrolled

United States: 50

Country: Number of subjects enrolled

Mexico: 3

Worldwide total number of subjects

124

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)

Children (2-11 years)

102

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 124 subjects were enrolled in this study.

Period 1 title

Overall (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

2 to <5 Years with Immunomodulatory Therapy

Arm description

Subjects aged 2 to <5 years receiving immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 3 microgram (mcg) of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

3 micrograms BNT162b2 administered intramuscularly

2 to < 5 Years with Solid Organ Transplant

Arm description

Subjects aged 2 to <5 years who had solid organ transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

3 micrograms BNT162b2 administered intramuscularly

2 to < 5 Years with Stem Cell Transplant

Arm description

Subjects aged 2 to <5 years who had stem cell transplant were administered four doses of 3 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

3 micrograms BNT162b2 administered intramuscularly

5 to <12 Years with Immunomodulatory Therapy

Arm description

Subjects aged 5 to <12 years receiving immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

10 micrograms BNT162b2 administered intramuscularly

5 to <12 Years with Solid Organ Transplant

Arm description

Subjects aged 5 to <12 years who had solid organ transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

10 micrograms BNT162b2 administered intramuscularly

5 to <12 Years with Stem Cell Transplant

Arm description

Subjects aged 5 to <12 years who had stem cell transplant were administered four doses of 10 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

10 micrograms BNT162b2 administered intramuscularly

12 to <18 Years with Immunomodulatory Therapy

Arm description

Subjects aged 12 to <18 years receiving immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 micrograms BNT162b2 administered intramuscularly

12 to <18 Years with Solid Organ Transplant

Arm description

Subjects aged 12 to <18 years who had solid organ transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 micrograms BNT162b2 administered intramuscularly

12 to <18 Years with Stem Cell Transplant

Arm description

Subjects aged 12 to <18 years who had stem cell transplant were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 micrograms BNT162b2 administered intramuscularly

>=18 Years with Immunomodulatory Therapy

Arm description

Subjects aged >=18 years receiving immunomodulator therapy for an autoimmune inflammatory disorder were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 micrograms BNT162b2 administered intramuscularly

>=18 Years with Non-Small Cell Lung Cancer

Arm description

Subjects with non-small cell lung cancer aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 micrograms BNT162b2 administered intramuscularly

>= 18 Years with Haemodialysis

Arm description

Subjects undergone maintenance haemodialysis treatment aged >=18 years were administered four doses of 30 mcg of BNT162b2 intramuscularly. The first 2 doses were separated by 21 days, the third dose was administered 28 days after Dose 2 and fourth dose was administered 3 to 6 months after Dose 3.

Arm type

Experimental

Investigational medicinal product name

BNT162b2

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

30 micrograms BNT162b2 administered intramuscularly

Number of subjects in period 1	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Started	9	15	13	19	24	22	7	1	7	5	1	1
Dose 1	9	15	13	19	24	22	7	1	7	5	1	1
Dose 2	9	15	12	19	24	22	7	1	7	5	1	1
Dose 3	9	15	11	17	24	22	7	1	6	5	1	1
Dose 4	7	13	6	14 ^[1]	20	17 ^[2]	5	1	3	3	1	0
Completed	7	12	6	16	20	18	5	0	3	3	1	0
Not completed	2	3	7	3	4	4	2	1	4	2	0	1
Refused further study procedures	-	-	1	-	-	-	-	-	-	-	-	-
Unspecified	-	-	1	1	-	-	-	-	-	1	-	-
Lost to follow-up	-	-	1	-	-	1	-	-	1	-	-	-
Withdrawal by parent/guardian	2	3	3	1	3	2	1	-	3	-	-	-
Protocol deviation	-	-	1	1	1	-	-	1	-	-	-	-
Withdrawal by subject	-	-	-	-	-	1	1	-	-	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: Milestone includes only subjects who received doses. The study completion includes subjects who completed the study 6 months after Dose 3 (per protocol amendment 3) and subjects who completed the study 6 months after Dose 4 (per protocol amendment 4).
[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: Milestone includes only subjects who received doses. The study completion includes subjects who completed the study 6 months after Dose 3 (per protocol amendment 3) and subjects who completed the study 6 months after Dose 4 (per protocol amendment 4).

Baseline characteristics

Top of page

Reporting group title

2 to <5 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

2 to < 5 Years with Solid Organ Transplant

Reporting group description

Reporting group title

2 to < 5 Years with Stem Cell Transplant

Reporting group description

Reporting group title

5 to <12 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

5 to <12 Years with Solid Organ Transplant

Reporting group description

Reporting group title

5 to <12 Years with Stem Cell Transplant

Reporting group description

Reporting group title

12 to <18 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

12 to <18 Years with Solid Organ Transplant

Reporting group description

Reporting group title

12 to <18 Years with Stem Cell Transplant

Reporting group description

Reporting group title

>=18 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

>=18 Years with Non-Small Cell Lung Cancer

Reporting group description

Reporting group title

>= 18 Years with Haemodialysis

Reporting group description

Reporting group values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis	Total
Number of subjects	9	15	13	19	24	22	7	1	7	5	1	1	124
Age Categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	9	15	13	19	24	22	0	0	0	0	0	0	102
Adolescents (12-17 years)	0	0	0	0	0	0	7	1	7	0	0	0	15
Adults (18-64 years)	0	0	0	0	0	0	0	0	0	3	1	1	5
From 65-84 years	0	0	0	0	0	0	0	0	0	2	0	0	2
85 years and over	0	0	0	0	0	0	0	0	0	0	0	0	0
Age Continuous
Units: years
median (full range (min-max))	3.0 (2 to 4)	4.0 (2 to 5)	3.0 (2 to 4)	10.0 (5 to 11)	8.0 (5 to 11)	8.5 (6 to 11)	13.0 (12 to 16)	14.0 (14 to 14)	12.0 (12 to 15)	39.0 (31 to 73)	40.0 (40 to 40)	62.0 (62 to 62)	-
Gender Categorical
Units: Subjects
Female	4	8	3	12	9	5	2	0	5	3	0	0	51
Male	5	7	10	7	15	17	5	1	2	2	1	1	73
Race
Units: Subjects
White	9	11	12	17	21	19	6	1	7	1	0	0	104
Black or African American	0	2	0	1	0	3	0	0	0	2	0	0	8
Asian	0	1	0	0	1	0	1	0	0	0	0	0	3
Multiracial	0	0	1	0	1	0	0	0	0	1	0	0	3
Not reported	0	1	0	1	1	0	0	0	0	1	0	1	5
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	1	0	1
Ethinicity
Units: Subjects
Hispanic/Latino	1	1	4	6	2	2	3	0	1	2	1	1	24
Non-Hispanic/non-Latino	8	14	9	13	22	19	4	1	6	3	0	0	99
Not reported	0	0	0	0	0	1	0	0	0	0	0	0	1

End points

Top of page

Reporting group title

2 to <5 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

2 to < 5 Years with Solid Organ Transplant

Reporting group description

Reporting group title

2 to < 5 Years with Stem Cell Transplant

Reporting group description

Reporting group title

5 to <12 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

5 to <12 Years with Solid Organ Transplant

Reporting group description

Reporting group title

5 to <12 Years with Stem Cell Transplant

Reporting group description

Reporting group title

12 to <18 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

12 to <18 Years with Solid Organ Transplant

Reporting group description

Reporting group title

12 to <18 Years with Stem Cell Transplant

Reporting group description

Reporting group title

>=18 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

>=18 Years with Non-Small Cell Lung Cancer

Reporting group description

Reporting group title

>= 18 Years with Haemodialysis

Reporting group description

Primary: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Top of page

End point title

Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[1] ^[2]

End point description

GMT of SARS-CoV-2 neutralizing titers at 1 month after vaccination 3 in subjects without serological or virological evidence of past SARS-CoV-2 infection will be reported in this endpoint. Results for this endpoint will be posted by March 2024.

End point type

Primary

End point timeframe

1 Month after Vaccination 3

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[2] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	0 ^[3]	0 ^[4]	0 ^[5]
Units: Titers
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[3] - Results for this endpoint will be posted by March 2024.
[4] - Results for this endpoint will be posted by March 2024.
[5] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Top of page

End point title

GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[6] ^[7]

End point description

End point type

Primary

End point timeframe

1 Month after Vaccination 3

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	0 ^[8]	0 ^[9]	0 ^[10]
Units: Titers
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[8] - Results for this endpoint will be posted by March 2024.
[9] - Results for this endpoint will be posted by March 2024.
[10] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Top of page

End point title

GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[11] ^[12]

End point description

End point type

Primary

End point timeframe

1 Month after Vaccination 3

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	0 ^[13]	0 ^[14]	0 ^[15]
Units: Titer
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[13] - Results for this endpoint will be posted by March 2024.
[14] - Results for this endpoint will be posted by March 2024.
[15] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Top of page

End point title

GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[16] ^[17]

End point description

End point type

Primary

End point timeframe

1 Month after Vaccination 3

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[17] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	0 ^[18]	0 ^[19]	0 ^[20]
Units: Titers
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[18] - Results for this endpoint will be posted by March 2024.
[19] - Results for this endpoint will be posted by March 2024.
[20] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Top of page

End point title

GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[21] ^[22]

End point description

GMT of SARS-CoV-2 neutralizing titers at 1 month after vaccination 4 in subjects without serological or virological evidence of past SARS-CoV-2 infection will be reported in this endpoint. Results for this endpoint will be posted by March 2024.

End point type

Primary

End point timeframe

1 Month after Vaccination 4

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[22] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	0 ^[23]	0 ^[24]	0 ^[25]
Units: Titer
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[23] - Results for this endpoint will be posted by March 2024.
[24] - Results for this endpoint will be posted by March 2024.
[25] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Top of page

End point title

GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[26] ^[27]

End point description

End point type

Primary

End point timeframe

1 Month after Vaccination 4

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[27] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	0 ^[28]	0 ^[29]	0 ^[30]
Units: Titer
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[28] - Results for this endpoint will be posted by March 2024.
[29] - Results for this endpoint will be posted by March 2024.
[30] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Top of page

End point title

GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[31] ^[32]

End point description

End point type

Primary

End point timeframe

1 Month after Vaccination 4

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[32] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	0 ^[33]	0 ^[34]	0 ^[35]
Units: Titer
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[33] - Results for this endpoint will be posted by March 2024.
[34] - Results for this endpoint will be posted by March 2024.
[35] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

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End point title

GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection ^[36] ^[37]

End point description

End point type

Primary

End point timeframe

1 Month after Vaccination 4

Notes
[36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[37] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	0 ^[38]	0 ^[39]	0 ^[40]
Units: Titer
geometric mean (confidence interval 95%)	( to )	( to )	( to )

Notes
[38] - Results for this endpoint will be posted by March 2024.
[39] - Results for this endpoint will be posted by March 2024.
[40] - Results for this endpoint will be posted by March 2024.

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years ^[41] ^[42]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to 7 after vaccination.Redness and swelling were measured and recorded in measuring device units(mdu) where, 1 mdu =0.5 cm and were graded as mild(>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm),severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild(did not interfere with activity),moderate(interfered with activity),severe(prevented daily activity) and Grade 4(emergency room [ER] visit or hospitalisation for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person.Reactions reported as adverse events in case report form within 7 days of study vaccination included.Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all subjects who received at least 1 dose of study intervention. Overall Number Analysed (N)= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[42] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	13
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	0 (0.0 to 24.7)
Redness: Mild	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	0 (0.0 to 24.7)
Redness: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Redness: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Redness: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Swelling: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Swelling: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Swelling: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Swelling: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Swelling: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Pain at the injection site: Any	11.1 (0.3 to 48.2)	13.3 (1.7 to 40.5)	23.1 (5.0 to 53.8)
Pain at the injection site: Mild	11.1 (0.3 to 48.2)	13.3 (1.7 to 40.5)	23.1 (5.0 to 53.8)
Pain at the injection site: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Pain at the injection site: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Pain at the injection site: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years ^[43] ^[44]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination.Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[44] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	19	24	22
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	10.5 (1.3 to 33.1)	8.3 (1.0 to 27.0)	9.1 (1.1 to 29.2)
Redness: Mild	10.5 (1.3 to 33.1)	4.2 (0.1 to 21.1)	4.5 (0.1 to 22.8)
Redness: Moderate	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	4.5 (0.1 to 22.8)
Redness: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Redness: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Swelling: Any	5.3 (0.1 to 26.0)	4.2 (0.1 to 21.1)	18.2 (5.2 to 40.3)
Swelling: Mild	5.3 (0.1 to 26.0)	0 (0.0 to 14.2)	13.6 (2.9 to 34.9)
Swelling: Moderate	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	4.5 (0.1 to 22.8)
Swelling: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Swelling: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Pain at the injection site: Any	73.7 (48.8 to 90.9)	58.3 (36.6 to 77.9)	54.5 (32.2 to 75.6)
Pain at the injection site: Mild	52.6 (28.9 to 75.6)	50.0 (29.1 to 70.9)	45.5 (24.4 to 67.8)
Pain at the injection site: Moderate	21.1 (6.1 to 45.6)	8.3 (1.0 to 27.0)	9.1 (1.1 to 29.2)
Pain at the injection site: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Pain at the injection site: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years ^[45] ^[46]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population = all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[46] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	7
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	14.3 (0.4 to 57.9)
Redness: Mild	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	14.3 (0.4 to 57.9)
Redness: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Redness: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Redness: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Swelling: Any	28.6 (3.7 to 71.0)	100.0 (2.5 to 100.0)	14.3 (0.4 to 57.9)
Swelling: Mild	0 (0.0 to 41.0)	100.0 (2.5 to 100.0)	0 (0.0 to 41.0)
Swelling: Moderate	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	14.3 (0.4 to 57.9)
Swelling: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Swelling: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Pain at the injection site: Any	85.7 (42.1 to 99.6)	100.0 (2.5 to 100.0)	57.1 (18.4 to 90.1)
Pain at the injection site: Mild	71.4 (29.0 to 96.3)	100.0 (2.5 to 100.0)	28.6 (3.7 to 71.0)
Pain at the injection site: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	28.6 (3.7 to 71.0)
Pain at the injection site: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Pain at the injection site: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years ^[47] ^[48]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population = all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[48] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	5	1	1
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Moderate	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Moderate	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Pain at injection site: Any	80.0 (28.4 to 99.5)	100.0 (2.5 to 100.0)	100.0 (2.5 to 100.0)
Pain at injection site: Mild	40.0 (5.3 to 85.3)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Pain at injection site: Moderate	40.0 (5.3 to 85.3)	0 (0.0 to 97.5)	100.0 (2.5 to 100.0)
Pain at injection site: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Pain at injection site: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years ^[49] ^[50]

End point description

Local reactions collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>0.5 to 2.0 cm),moderate(>2.0 to 7.0 cm), severe(>7.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis[redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity),Grade 4(ER visit or hospitalisation for severe pain at injection site).Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population =all subjects who received at least 1 dose of study intervention.' N'= subjects evaluable for this endpoint. Number Analysed (‘n’)= subjects evaluable for specified rows.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[50] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	11
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any (n=9,15,10)	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 30.8)
Redness: Mild (n=9,15,10)	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 30.8)
Redness: Moderate (n=9,15,10)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Redness: Severe (n=9,15,10)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Redness: Grade 4 (n=9,15,10)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Swelling: Any (n=9,15,10)	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 30.8)
Swelling: Mild (n=9,15,10)	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 30.8)
Swelling: Moderate (n=9,15,10)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Swelling: Severe (n=9,15,10)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Swelling: Grade 4 (n=9,15,10)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Pain at injection site: Any (n=9,15,11)	11.1 (0.3 to 48.2)	20.0 (4.3 to 48.1)	9.1 (0.2 to 41.3)
Pain at injection site: Mild (n=9,15,11)	11.1 (0.3 to 48.2)	20.0 (4.3 to 48.1)	9.1 (0.2 to 41.3)
Pain at injection site: Moderate (n=9,15,11)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Pain at injection site: Severe (n=9,15,11)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Pain at injection site: Grade 4 (n=9,15,11)	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years

Top of page

End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years ^[51] ^[52]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[52] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	19	24	22
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	10.5 (1.3 to 33.1)	12.5 (2.7 to 32.4)	22.7 (7.8 to 45.4)
Redness: Mild	10.5 (1.3 to 33.1)	4.2 (0.1 to 21.1)	13.6 (2.9 to 34.9)
Redness: Moderate	0 (0.0 to 17.6)	8.3 (1.0 to 27.0)	9.1 (1.1 to 29.2)
Redness: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Redness: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Swelling: Any	10.5 (1.3 to 33.1)	8.3 (1.0 to 27.0)	31.8 (13.9 to 54.9)
Swelling: Mild	10.5 (1.3 to 33.1)	4.2 (0.1 to 21.1)	9.1 (1.1 to 29.2)
Swelling: Moderate	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	22.7 (7.8 to 45.4)
Swelling: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Swelling: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Pain at injection site: Any	68.4 (43.4 to 87.4)	62.5 (40.6 to 81.2)	50.0 (28.2 to 71.8)
Pain at injection site: Mild	52.6 (28.9 to 75.6)	45.8 (25.6 to 67.2)	22.7 (7.8 to 45.4)
Pain at injection site: Moderate	15.8 (3.4 to 39.6)	16.7 (4.7 to 37.4)	27.3 (10.7 to 50.2)
Pain at injection site: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Pain at injection site: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years

Top of page

End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years ^[53] ^[54]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population = all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[54] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	6
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
Redness: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
Redness: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Redness: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Redness: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Any	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
Swelling: Mild	0 (0.0 to 41.0)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
Swelling: Moderate	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Pain at injection site: Any	85.7 (42.1 to 99.6)	100.0 (2.5 to 100.0)	57.1 (18.4 to 90.1)
Pain at injection site: Mild	57.1 (18.4 to 90.1)	100.0 (2.5 to 100.0)	28.6 (3.7 to 71.0)
Pain at injection site: Moderate	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	28.6 (3.7 to 71.0)
Pain at injection site: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Pain at injection site: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years ^[55] ^[56]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population = all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[56] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	5	1	1
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Moderate	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Redness: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Moderate	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Swelling: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Pain at injection site: Any	80.0 (28.4 to 99.5)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Pain at injection site: Mild	60.0 (14.7 to 94.7)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Pain at injection site: Moderate	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Pain at injection site: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Pain at injection site: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years ^[57] ^[58]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[58] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	11
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	11.1 (0.3 to 48.2)	13.3 (1.7 to 40.5)	0 (0.0 to 28.5)
Redness: Mild	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Redness: Moderate	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Redness: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Redness: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Swelling: Any	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Swelling: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Swelling: Moderate	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Swelling: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Swelling: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Pain at injection site: Any	22.2 (2.8 to 60.0)	13.3 (1.7 to 40.5)	9.1 (0.2 to 41.3)
Pain at injection site: Mild	0 (0.0 to 33.6)	13.3 (1.7 to 40.5)	9.1 (0.2 to 41.3)
Pain at injection site: Moderate	22.2 (2.8 to 60.0)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Pain at injection site: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Pain at injection site: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years ^[59] ^[60]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[60] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	17	23	21
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	29.4 (10.3 to 56.0)	4.3 (0.1 to 21.9)	14.3 (3.0 to 36.3)
Redness: Mild	17.6 (3.8 to 43.4)	0 (0.0 to 14.8)	9.5 (1.2 to 30.4)
Redness: Moderate	11.8 (1.5 to 36.4)	4.3 (0.1 to 21.9)	4.8 (0.1 to 23.8)
Redness: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Redness: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Swelling: Any	17.6 (3.8 to 43.4)	8.7 (1.1 to 28.0)	14.3 (3.0 to 36.3)
Swelling: Mild	5.9 (0.1 to 28.7)	0 (0.0 to 14.8)	9.5 (1.2 to 30.4)
Swelling: Moderate	11.8 (1.5 to 36.4)	8.7 (1.1 to 28.0)	4.8 (0.1 to 23.8)
Swelling: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Swelling: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Pain at injection site: Any	70.6 (44.0 to 89.7)	26.1 (10.2 to 48.4)	57.1 (34.0 to 78.2)
Pain at injection site: Mild	35.3 (14.2 to 61.7)	21.7 (7.5 to 43.7)	42.9 (21.8 to 66.0)
Pain at injection site: Moderate	35.3 (14.2 to 61.7)	4.3 (0.1 to 21.9)	14.3 (3.0 to 36.3)
Pain at injection site: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Pain at injection site: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years ^[61] ^[62]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate(>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate(interfered with activity), severe(prevented daily activity) and Grade 4(ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population= all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint. ‘n’= subjects evaluable for specified rows.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[62] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	7
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any (n= 7,1,6)	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Redness: Mild (n= 7,1,6)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Redness: Moderate (n= 7,1,6)	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Redness: Severe (n= 7,1,6)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Redness: Grade 4 (n= 7,1,6)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Any (n= 7,1,6)	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Mild (n= 7,1,6)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Moderate (n= 7,1,6)	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Severe (n= 7,1,6)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Swelling: Grade 4 (n= 7,1,6)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Pain at injection site: Any (n= 7,1,7)	71.4 (29.0 to 96.3)	100.0 (2.5 to 100.0)	66.7 (22.3 to 95.7)
Pain at injection site: Mild (n= 7,1,7)	28.6 (3.7 to 71.0)	100.0 (2.5 to 100.0)	33.3 (4.3 to 77.7)
Pain at injection site: Moderate (n= 7,1,7)	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	33.3 (4.3 to 77.7)
Pain at injection site: Severe (n= 7,1,7)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Pain at injection site: Grade 4 (n= 7,1,7)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=18 Years ^[63] ^[64]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population = all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[64] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	4	0 ^[65]	1
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Redness: Mild	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Redness: Moderate	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Redness: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Redness: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Swelling: Any	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Swelling: Mild	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Swelling: Moderate	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Swelling: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Swelling: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Pain at injection site: Any	75.0 (19.4 to 99.4)	( to )	0 (0.0 to 97.5)
Pain at injection site: Mild	50.0 (6.8 to 93.2)	( to )	0 (0.0 to 97.5)
Pain at injection site: Moderate	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Pain at injection site: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Pain at injection site: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)

Notes
[65] - No subjects were evaluable for this endpoint from this arm.

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=2 to <5 Years ^[66] ^[67]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[67] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	7	6	6
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	28.6 (3.7 to 71.0)	16.7 (0.4 to 64.1)	0 (0.0 to 45.9)
Redness: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Redness: Moderate	14.3 (0.4 to 57.9)	16.7 (0.4 to 64.1)	0 (0.0 to 45.9)
Redness: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Redness: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Swelling: Any	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	16.7 (0.4 to 64.1)
Swelling: Mild	0 (0.0 to 41.0)	0 (0.0 to 45.9)	16.7 (0.4 to 64.1)
Swelling: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Swelling: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Swelling: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Pain at injection site: Any	28.6 (3.7 to 71.0)	0 (0.0 to 45.9)	16.7 (0.4 to 64.1)
Pain at injection site: Mild	28.6 (3.7 to 71.0)	0 (0.0 to 45.9)	16.7 (0.4 to 64.1)
Pain at injection site: Moderate	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Pain at injection site: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Pain at injection site: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=5 to <12 Years ^[68] ^[69]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[69] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	12	19	15
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	20.0 (4.3 to 48.1)
Redness: Mild	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	6.7 (0.2 to 31.9)
Redness: Moderate	0 (0.0 to 26.5)	0 (0.0 to 17.6)	13.3 (1.7 to 40.5)
Redness: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Redness: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Swelling: Any	16.7 (2.1 to 48.4)	5.3 (0.1 to 26.0)	20.0 (4.3 to 48.1)
Swelling: Mild	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	13.3 (1.7 to 40.5)
Swelling: Moderate	8.3 (0.2 to 38.5)	0 (0.0 to 17.6)	6.7 (0.2 to 31.9)
Swelling: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Swelling: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Pain at injection site: Any	91.7 (61.5 to 99.8)	42.1 (20.3 to 66.5)	40.0 (16.3 to 67.7)
Pain at injection site: Mild	41.7 (15.2 to 72.3)	31.6 (12.6 to 56.6)	26.7 (7.8 to 55.1)
Pain at injection site: Moderate	50.0 (21.1 to 78.9)	10.5 (1.3 to 33.1)	13.3 (1.7 to 40.5)
Pain at injection site: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Pain at injection site: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=12 to <18 Years ^[70] ^[71]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population = all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[71] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	4	1	3
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	75.0 (19.4 to 99.4)	0 (0.0 to 97.5)	66.7 (9.4 to 99.2)
Redness: Mild	75.0 (19.4 to 99.4)	0 (0.0 to 97.5)	66.7 (9.4 to 99.2)
Redness: Moderate	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)
Redness: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)
Redness: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)
Swelling: Any	50.0 (6.8 to 93.2)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Swelling: Mild	0 (0.0 to 60.2)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Swelling: Moderate	50.0 (6.8 to 93.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)
Swelling: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)
Swelling: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)
Pain at injection site: Any	75.0 (19.4 to 99.4)	100.0 (2.5 to 100.0)	33.3 (0.8 to 90.6)
Pain at injection site: Mild	25.0 (19.4 to 99.4)	100.0 (2.5 to 100.0)	0 (0.0 to 70.8)
Pain at injection site: Moderate	50.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Pain at injection site: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)
Pain at injection site: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=18 Years ^[72] ^[73]

End point description

Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 (ER visit or hospitalisation for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method. Safety population = all subjects who received at least 1 dose of study intervention. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[73] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	3	1	0 ^[74]
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Any	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Redness: Mild	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Redness: Moderate	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Redness: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Redness: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Swelling: Any	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Swelling: Mild	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Swelling: Moderate	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Swelling: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Swelling: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Pain at injection site: Any	66.7 (9.4 to 99.2)	100.0 (2.5 to 100.0)	( to )
Pain at injection site: Mild	33.3 (0.8 to 90.6)	100.0 (2.5 to 100.0)	( to )
Pain at injection site: Moderate	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Pain at injection site: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Pain at injection site: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )

Notes
[74] - No subjects were evaluable for this endpoint from this arm.

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years ^[75] ^[76]

End point description

Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after vaccination. Fever:oral temperature >=) 38.0 degree C (C);categorised as >=38.0 to 38.4 C, >38.4 to 38.9 C, >38.9 to 40.0 C and >40.0 degree C.Fatigue, headache,chills,new or worsened muscle pain and new or worsened joint pain:mild (did not interfere with activity), moderate (some interference with activity),severe (prevented daily routine activity).Vomiting: mild: 1-2 times in 24 hours,moderate: >2 times in 24 hours,severe: required intravenous hydration .Diarrhea: mild: 2-3 loose stools in 24 hours,moderate: 4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours.Grade 4 for all events:ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included.Exact 95% CI based on Clopper and Pearson method.Safety population. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[75] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[76] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	13
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	15.4 (1.9 to 45.4)
Fever: >=38.0 to 38.4 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	7.7 (0.2 to 36.0)
Fever: >38.4 to 38.9 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Fever: >38.9 to 40.0 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	7.7 (0.2 to 36.0)
Fever: >40.0 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Fatigue: Any	22.2 (2.8 to 60.0)	6.7 (0.2 to 31.9)	7.7 (0.2 to 36.0)
Fatigue: Mild	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Fatigue: Moderate	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	7.7 (0.2 to 36.0)
Fatigue: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Fatigue: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Headache: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Headache: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Headache: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Headache: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Headache: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Chills: Any	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	7.7 (0.2 to 36.0)
Chills: Mild	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Chills: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	7.7 (0.2 to 36.0)
Chills: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Chills: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Vomiting: Any	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	23.1 (5.0 to 53.8)
Vomiting: Mild	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	7.7 (0.2 to 36.0)
Vomiting: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	15.4 (1.9 to 45.4)
Vomiting: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Vomiting: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Diarrhea: Any	0 (0.0 to 33.6)	20.0 (4.3 to 48.1)	7.7 (0.2 to 36.0)
Diarrhea: Mild	0 (0.0 to 33.6)	20.0 (4.3 to 48.1)	0 (0.0 to 24.7)
Diarrhea: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
Diarrhea: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	7.7 (0.2 to 36.0)
Diarrhea: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened muscle pain: Any	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened muscle pain: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened muscle pain: Moderate	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened muscle pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened muscle pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened joint pain: Any	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened joint pain: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened joint pain: Moderate	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened joint pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)
New or worsened joint pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 24.7)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years ^[77] ^[78]

End point description

Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after vaccination.Fever:oral temperature >= 38.0 C;categorised as >=38.0 to 38.4 C, >38.4 to 38.9 C, >38.9 to 40.0 C and >40.0 C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe: required intravenous hydration .Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[78] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	19	24	22
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
Fever: >=38.0 to 38.4 deg C	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fever: >38.4 to 38.9 deg C	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
Fever: >38.9 to 40.0 deg C	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fever: >40.0 deg C	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fatigue: Any	47.4 (24.4 to 71.1)	37.5 (18.8 to 59.4)	22.7 (7.8 to 45.4)
Fatigue: Mild	31.6 (12.6 to 56.6)	20.8 (7.1 to 42.2)	13.6 (2.9 to 34.9)
Fatigue: Moderate	15.8 (3.4 to 39.6)	16.7 (4.7 to 37.4)	9.1 (1.1 to 29.2)
Fatigue: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fatigue: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Headache: Any	42.1 (20.3 to 66.5)	12.5 (2.7 to 32.4)	22.7 (7.8 to 45.4)
Headache: Mild	31.6 (12.6 to 56.6)	12.5 (2.7 to 32.4)	9.1 (1.1 to 29.2)
Headache: Moderate	10.5 (1.3 to 33.1)	0 (0.0 to 14.2)	13.6 (2.9 to 34.9)
Headache: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Headache: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Chills: Any	5.3 (0.1 to 26.0)	0 (0.0 to 14.2)	4.5 (0.1 to 22.8)
Chills: Mild	0 (0.0 to 17.6)	0 (0.0 to 14.2)	4.5 (0.1 to 22.8)
Chills: Moderate	5.3 (0.1 to 26.0)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Chills: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Chills: Grade 4	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
Vomiting: Any	5.3 (0.1 to 26.0)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Vomiting: Mild	5.3 (0.1 to 26.0)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
Vomiting: Moderate	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Vomiting: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Vomiting: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Diarrhea: Any	10.5 (1.3 to 33.1)	0 (0.0 to 14.2)	4.5 (0.1 to 22.8)
Diarrhea: Mild	10.5 (1.3 to 33.1)	0 (0.0 to 14.2)	4.5 (0.1 to 22.8)
Diarrhea: Moderate	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Diarrhea: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Diarrhea: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened muscle pain: Any	5.3 (0.1 to 26.0)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
New or worsened muscle pain: Mild	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened muscle pain: Moderate	5.3 (0.1 to 26.0)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
New or worsened muscle pain: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened muscle pain: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Any	10.5 (1.3 to 33.1)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Mild	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Moderate	10.5 (1.3 to 33.1)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years ^[79] ^[80]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[80] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	7
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Fever: >=38.0 deg C to 38.4 deg C	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Fever: >38.4 deg C to 38.9 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Fever: >40.0 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Fatigue: Any	57.1 (18.4 to 90.1)	0 (0.0 to 97.5)	42.9 (9.9 to 81.6)
Fatigue: Mild	0 (0.0 to 41.0)	0 (0.0 to 97.5)	14.3 (0.4 to 57.9)
Fatigue: Moderate	57.1 (18.4 to 90.1)	0 (0.0 to 97.5)	28.6 (3.7 to 71.0)
Fatigue: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Fatigue: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Headache: Any	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	28.6 (3.7 to 71.0)
Headache: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	14.3 (0.4 to 57.9)
Headache: Moderate	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	14.3 (0.4 to 57.9)
Headache: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Headache: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Chills: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Chills: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Chills: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Chills: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Chills: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Vomiting: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Vomiting: Mild	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Vomiting: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Vomiting: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Vomiting: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Diarrhea: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	28.6 (3.7 to 71.0)
Diarrhea: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	28.6 (3.7 to 71.0)
Diarrhea: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Diarrhea: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
Diarrhea: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened muscle pain: Any	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	42.9 (9.9 to 81.6)
New or worsened muscle pain: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	42.9 (9.9 to 81.6)
New or worsened muscle pain: Moderate	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened muscle pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened muscle pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened joint pain: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened joint pain: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened joint pain: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened joint pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)
New or worsened joint pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years ^[81] ^[82]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 1

Notes
[81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[82] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	5	1	1
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >=38 to 38.4 deg C	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >38.4 to 38.9 deg C	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >38.9 to 40.0 deg C	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >40.0 deg C	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fatigue: Any	60.0 (14.7 to 94.7)	100.0 (2.5 to 100.0)	100.0 (2.5 to 100.0)
Fatigue: Mild	40.0 (5.3 to 85.3)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Fatigue: Moderate	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	100.0 (2.5 to 100.0)
Fatigue: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fatigue: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Any	40.0 (5.3 to 85.3)	0 (0.0 to 97.5)	100.0 (2.5 to 100.0)
Headache: Mild	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	100.0 (2.5 to 100.0)
Headache: Moderate	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Moderate	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Moderate	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Grade 4	0 (0.0 to 85.3)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Any	40.0 (5.3 to 85.3)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Diarrhea: Mild	40.0 (5.3 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Moderate	0 (0.0 to 52.2)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Diarrhea: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Any	20.0 (0.5 to 71.6)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
New or worsened muscle pain: Mild	0 (0.0 to 52.2)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
New or worsened muscle pain: Moderate	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Any	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Moderate	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years ^[83] ^[84]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[83] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[84] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	10
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Fever: >=38.0 deg C to 38.4 deg C	11.1 (0.3 to 48.2)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Fever: >38.4 deg C to 38.9 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Fever: >40.0 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Fatigue: Any	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	10.0 (0.3 to 44.5)
Fatigue: Mild	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	10.0 (0.3 to 44.5)
Fatigue: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Fatigue: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Fatigue: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Headache: Any	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 30.8)
Headache: Mild	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 30.8)
Headache: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Headache: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Headache: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Chills: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Chills: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Chills: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Chills: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Chills: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Vomiting: Any	0 (0.0 to 33.6)	13.3 (1.7 to 40.5)	10.0 (0.3 to 44.5)
Vomiting: Mild	0 (0.0 to 33.6)	13.3 (1.7 to 40.5)	0 (0.0 to 30.8)
Vomiting: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	10.0 (0.3 to 44.5)
Vomiting: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Vomiting: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Diarrhea: Any	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	10.0 (0.3 to 44.5)
Diarrhea: Mild	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	10.0 (0.3 to 44.5)
Diarrhea: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Diarrhea: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
Diarrhea: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened muscle pain: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened muscle pain: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened muscle pain: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened muscle pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened muscle pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened joint pain: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened joint pain: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 30.8)
New or worsened joint pain: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened joint pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened joint pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years ^[85] ^[86]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[85] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[86] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	19	24	22
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	5.3 (0.1 to 26.0)	0 (0.0 to 14.2)	4.5 (0.1 to 22.8)
Fever: >=38.0 deg C to 38.4 deg C	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fever: >38.4 deg C to 38.9 deg C	5.3 (0.1 to 26.0)	0 (0.0 to 14.2)	4.5 (0.1 to 22.8)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fever: >40.0 deg C	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fatigue: Any	57.9 (33.5 to 79.7)	37.5 (18.8 to 59.4)	45.5 (24.4 to 67.8)
Fatigue: Mild	26.3 (9.1 to 51.2)	20.8 (7.1 to 42.2)	13.6 (2.9 to 34.9)
Fatigue: Moderate	31.6 (12.6 to 56.6)	16.7 (4.7 to 37.4)	31.8 (13.9 to 54.9)
Fatigue: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Fatigue: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Headache: Any	36.8 (16.3 to 61.6)	29.2 (12.6 to 51.1)	18.2 (5.2 to 40.3)
Headache: Mild	15.8 (3.4 to 39.6)	12.5 (2.7 to 32.4)	4.5 (0.1 to 22.8)
Headache: Moderate	21.1 (6.1 to 45.6)	16.7 (4.7 to 37.4)	13.6 (2.9 to 34.9)
Headache: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Headache: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Chills: Any	21.1 (6.1 to 45.6)	4.2 (0.1 to 21.1)	4.5 (0.1 to 22.8)
Chills: Mild	10.5 (1.3 to 33.1)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
Chills: Moderate	10.5 (1.3 to 33.1)	0 (0.0 to 14.2)	4.5 (0.1 to 22.8)
Chills: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Chills: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Vomiting: Any	0 (0.0 to 17.6)	12.5 (2.7 to 32.4)	0 (0.0 to 15.4)
Vomiting: Mild	0 (0.0 to 17.6)	12.5 (2.7 to 32.4)	0 (0.0 to 15.4)
Vomiting: Moderate	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Vomiting: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Vomiting: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Diarrhea: Any	5.3 (0.1 to 26.0)	8.3 (1.0 to 27.0)	4.5 (0.1 to 22.8)
Diarrhea: Mild	5.3 (0.1 to 26.0)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
Diarrhea: Moderate	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	4.5 (0.1 to 22.8)
Diarrhea: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
Diarrhea: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened muscle pain: Any	10.5 (1.3 to 33.1)	12.5 (2.7 to 32.4)	4.5 (0.1 to 22.8)
New or worsened muscle pain: Mild	0 (0.0 to 17.6)	4.2 (0.1 to 21.1)	0 (0.0 to 15.4)
New or worsened muscle pain: Moderate	10.5 (1.3 to 33.1)	8.3 (1.0 to 27.0)	4.5 (0.1 to 22.8)
New or worsened muscle pain: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened muscle pain: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Any	15.8 (3.4 to 39.6)	4.2 (0.1 to 21.1)	4.5 (0.1 to 22.8)
New or worsened joint pain: Mild	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Moderate	15.8 (3.4 to 39.6)	4.2 (0.1 to 21.1)	4.5 (0.1 to 22.8)
New or worsened joint pain: Severe	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)
New or worsened joint pain: Grade 4	0 (0.0 to 17.6)	0 (0.0 to 14.2)	0 (0.0 to 15.4)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years ^[87] ^[88]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[87] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[88] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	6
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fever: >=38.0 deg C to 38.4 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fever: >38.4 deg C to 38.9 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fever: >38.9 deg C to 40.0 deg C	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fever: >40.0 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fatigue: Any	85.7 (42.1 to 99.6)	0 (0.0 to 97.5)	33.3 (4.3 to 77.7)
Fatigue: Mild	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	33.3 (4.3 to 77.7)
Fatigue: Moderate	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fatigue: Severe	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fatigue: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Headache: Any	71.4 (29.0 to 96.3)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
Headache: Mild	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
Headache: Moderate	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Headache: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Headache: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Any	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Mild	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Any	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened muscle pain: Any	42.9 (9.9 to 81.6)	100.0 (2.5 to 100.0)	16.7 (0.4 to 64.1)
New or worsened muscle pain: Mild	0 (0.0 to 41.0)	100.0 (2.5 to 100.0)	0 (0.0 to 45.9)
New or worsened muscle pain: Moderate	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
New or worsened muscle pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened muscle pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Any	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Mild	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years ^[89] ^[90]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 2

Notes
[89] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[90] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	5	1	1
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >=38.0 to 38.4 deg C	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >38.4 to 38.9 deg C	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >38.9 to 40.0 deg C	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >40.0 deg C	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fatigue: Any	60.0 (14.7 to 94.7)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Fatigue: Mild	0 (0.0 to 52.2)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Fatigue: Moderate	60.0 (14.7 to 94.7)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fatigue: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fatigue: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Any	60.0 (14.7 to 94.7)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Headache: Mild	20.0 (0.5 to 71.6)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Headache: Moderate	40.0 (5.3 to 85.3)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Any	40.0 (5.3 to 85.3)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Moderate	40.0 (5.3 to 85.3)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Any	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Moderate	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Any	60.0 (14.7 to 94.7)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Diarrhea: Mild	40.0 (5.3 to 85.3)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Moderate	20.0 (0.5 to 71.6)	100.0 (2.5 to 100.0)	0 (0.0 to 97.5)
Diarrhea: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Any	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Moderate	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Any	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Mild	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Moderate	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Severe	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Grade 4	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years ^[91] ^[92]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[91] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[92] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	11
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Fever: >=38.0 deg C to 38.4 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Fever: >38.4 deg C to 38.9 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Fever: >40.0 deg C	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Fatigue: Any	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Fatigue: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Fatigue: Moderate	11.1 (0.3 to 48.2)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Fatigue: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Fatigue: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Headache: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Headache: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Headache: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Headache: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Headache: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Chills: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Chills: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Chills: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Chills: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Chills: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Vomiting: Any	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Vomiting: Mild	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
Vomiting: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Vomiting: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Vomiting: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Diarrhea: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Diarrhea: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Diarrhea: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Diarrhea: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
Diarrhea: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened muscle pain: Any	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
New or worsened muscle pain: Mild	0 (0.0 to 33.6)	6.7 (0.2 to 31.9)	0 (0.0 to 28.5)
New or worsened muscle pain: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened muscle pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened muscle pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened joint pain: Any	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened joint pain: Mild	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened joint pain: Moderate	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened joint pain: Severe	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)
New or worsened joint pain: Grade 4	0 (0.0 to 33.6)	0 (0.0 to 21.8)	0 (0.0 to 28.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years ^[93] ^[94]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[93] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[94] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	17	23	21
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	17.6 (3.8 to 43.4)	0 (0.0 to 14.8)	19.0 (5.4 to 41.9)
Fever: >=38.0 to 38.4 deg C	11.8 (1.5 to 36.4)	0 (0.0 to 14.8)	14.3 (3.0 to 36.3)
Fever: >38.4°C to 38.9 deg C	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Fever: >38.9°C to 40.0 deg C	0 (0.0 to 19.5)	0 (0.0 to 14.8)	4.8 (0.1 to 23.8)
Fever: >40.0 deg C	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Fever: Unknown	5.9 (0.1 to 28.7)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Fatigue: Any	47.1 (23.0 to 72.2)	34.8 (16.4 to 57.3)	52.4 (47.2 to 74.3)
Fatigue: Mild	35.3 (14.2 to 61.7)	34.8 (16.4 to 57.3)	23.8 (8.2 to 47.2)
Fatigue: Moderate	11.8 (1.5 to 36.4)	21.7 (7.5 to 43.7)	28.6 (11.3 to 52.2)
Fatigue: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Fatigue: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Headache: Any	35.3 (14.2 to 61.7)	8.7 (1.1 to 28.0)	28.6 (11.3 to 52.2)
Headache: Mild	29.4 (10.3 to 56.0)	4.3 (0.1 to 21.9)	9.5 (1.2 to 30.4)
Headache: Moderate	5.9 (0.1 to 28.7)	0 (0.0 to 14.8)	19.0 (5.4 to 41.9)
Headache: Severe	0 (0.0 to 19.5)	4.3 (0.1 to 21.9)	0 (0.0 to 16.1)
Headache: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Chills: Any	17.6 (3.8 to 43.4)	4.3 (0.1 to 21.9)	14.3 (3.0 to 36.3)
Chills: Mild	5.9 (0.1 to 28.7)	4.3 (0.1 to 21.9)	4.8 (0.1 to 23.8)
Chills: Moderate	11.8 (1.5 to 36.4)	0 (0.0 to 14.8)	9.5 (3.0 to 36.3)
Chills: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Chills: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Vomiting: Any	0 (0.0 to 19.5)	0 (0.0 to 14.8)	4.8 (0.1 to 23.8)
Vomiting: Mild	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Vomiting: Moderate	0 (0.0 to 19.5)	0 (0.0 to 14.8)	4.8 (0.1 to 23.8)
Vomiting: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Vomiting: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Diarrhea: Any	11.8 (1.5 to 36.4)	0 (0.0 to 14.8)	4.8 (0.1 to 23.8)
Diarrhea: Mild	11.8 (1.5 to 36.4)	0 (0.0 to 14.8)	4.8 (0.1 to 23.8)
Diarrhea: Moderate	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Diarrhea: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
Diarrhea: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
New or worsened muscle pain: Any	29.4 (10.3 to 56.0)	13.0 (2.8 to 33.6)	4.8 (0.1 to 23.8)
New or worsened muscle pain: Mild	5.9 (0.1 to 28.7)	13.0 (2.8 to 33.6)	4.8 (0.1 to 23.8)
New or worsened muscle pain: Moderate	23.5 (6.8 to 49.9)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
New or worsened muscle pain: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
New or worsened muscle pain: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
New or worsened joint pain: Any	11.8 (1.5 to 36.4)	4.3 (2.8 to 33.6)	4.8 (0.1 to 23.8)
New or worsened joint pain: Mild	0 (0.0 to 19.5)	4.3 (2.8 to 33.6)	4.8 (0.1 to 23.8)
New or worsened joint pain: Moderate	11.8 (1.5 to 36.4)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
New or worsened joint pain: Severe	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)
New or worsened joint pain: Grade 4	0 (0.0 to 19.5)	0 (0.0 to 14.8)	0 (0.0 to 16.1)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years ^[95] ^[96]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[95] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[96] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	6
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	42.9 (9.9 to 81.6)	0 (0.0 to 97.5)	33.3 (4.3 to 77.7)
Fever: >=38.0 to 38.4 deg C	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	33.3 (4.3 to 77.7)
Fever: >38.4°C to 38.9 deg C	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fever: >38.9°C to 40.0 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fever: >40.0 deg C	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fatigue: Any	85.7 (42.1 to 99.6)	100.0 (2.5 to 100.0)	50.0 (11.8 to 88.2)
Fatigue: Mild	14.3 (0.4 to 57.9)	100.0 (2.5 to 100.0)	50.0 (11.8 to 88.2)
Fatigue: Moderate	71.4 (29.0 to 96.3)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fatigue: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Fatigue: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Headache: Any	85.7 (42.1 to 99.6)	100.0 (2.5 to 100.0)	66.7 (22.3 to 95.7)
Headache: Mild	28.6 (3.7 to 71.0)	100.0 (2.5 to 100.0)	33.3 (4.3 to 77.7)
Headache: Moderate	57.1 (18.4 to 90.1)	0 (0.0 to 97.5)	33.3 (4.3 to 77.7)
Headache: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Headache: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Any	71.4 (29.0 to 96.3)	100.0 (2.5 to 100.0)	16.7 (0.4 to 64.1)
Chills: Mild	14.3 (0.4 to 57.9)	100.0 (2.5 to 100.0)	16.7 (0.4 to 64.1)
Chills: Moderate	57.1 (18.4 to 90.1)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Chills: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Any	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Mild	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Vomiting: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Moderate	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
Diarrhea: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened muscle pain: Any	28.6 (3.7 to 71.0)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
New or worsened muscle pain: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)
New or worsened muscle pain: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened muscle pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened muscle pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Any	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Mild	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)
New or worsened joint pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 45.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=18 Years ^[97] ^[98]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 3

Notes
[97] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[98] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	4	0 ^[99]	1
Units: Percentage of subjects
number (confidence interval 95%)
Fever:Any	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Fever: >=38.0 to 38.4 deg C	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Fever: >38.4 to 38.9 deg C	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Fever: >38.9 to 40.0 deg C	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Fever: >40.0 deg C	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Fatigue: Any	75.0 (19.4 to 99.4)	( to )	0 (0.0 to 97.5)
Fatigue: Mild	50.0 (6.8 to 93.2)	( to )	0 (0.0 to 97.5)
Fatigue: Moderate	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Fatigue: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Fatigue: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Headache: Any	75.0 (19.4 to 99.4)	( to )	0 (0.0 to 97.5)
Headache: Mild	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Headache: Moderate	50.0 (6.8 to 93.2)	( to )	0 (0.0 to 97.5)
Headache: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Headache: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Chills: Any	50.0 (0.6 to 93.2)	( to )	0 (0.0 to 97.5)
Chills: Mild	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Chills: Moderate	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Chills: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Chills: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Vomiting: Any	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Vomiting: Mild	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Vomiting: Moderate	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Vomiting: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Vomiting: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Diarrhea: Any	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Diarrhea: Mild	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Diarrhea: Moderate	25.0 (0.6 to 80.6)	( to )	0 (0.0 to 97.5)
Diarrhea: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
Diarrhea: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
New or worsened muscle pain: Any	50.0 (6.8 to 93.2)	( to )	0 (0.0 to 97.5)
New or worsened muscle pain: Mild	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
New or worsened muscle pain: Moderate	50.0 (6.8 to 93.2)	( to )	0 (0.0 to 97.5)
New or worsened muscle pain: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
New or worsened muscle pain: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
New or worsened joint pain: Any	50.0 (6.8 to 93.2)	( to )	0 (0.0 to 97.5)
New or worsened joint pain: Mild	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
New or worsened joint pain: Moderate	50.0 (6.8 to 93.2)	( to )	0 (0.0 to 97.5)
New or worsened joint pain: Severe	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)
New or worsened joint pain: Grade 4	0 (0.0 to 60.2)	( to )	0 (0.0 to 97.5)

Notes
[99] - No subjects were evaluable for this endpoint from this arm.

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=2 to <5 Years ^[100] ^[101]

End point description

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[100] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[101] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	7	6	6
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	28.6 (3.7 to 71.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Fever: >=38.0 to 38.4 deg C	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Fever: >38.4 to 38.9 deg C	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Fever: >38.9 to 40.0 deg C	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Fever: >40.0 deg C	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Fatigue: Any	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	16.7 (0.4 to 64.1)
Fatigue: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	16.7 (0.4 to 64.1)
Fatigue: Moderate	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Fatigue: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Fatigue: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Headache: Any	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Headache: Mild	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Headache: Moderate	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Headache: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Headache: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Chills: Any	14.3 (0.4 to 57.9)	16.7 (0.4 to 64.1)	0 (0.0 to 45.9)
Chills: Mild	0 (0.0 to 41.0)	16.7 (0.4 to 64.1)	0 (0.0 to 45.9)
Chills: Moderate	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Chills: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Chills: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Vomiting: Any	0 (0.0 to 41.0)	16.7 (0.4 to 64.1)	0 (0.0 to 45.9)
Vomiting: Mild	0 (0.0 to 41.0)	16.7 (0.4 to 64.1)	0 (0.0 to 45.9)
Vomiting: Moderate	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Vomiting: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Vomiting: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Diarrhea: Any	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Diarrhea: Mild	14.3 (0.4 to 57.9)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Diarrhea: Moderate	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Diarrhea: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
Diarrhea: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened muscle pain: Any	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened muscle pain: Mild	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened muscle pain: Moderate	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened muscle pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened muscle pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened joint pain: Any	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened joint pain: Mild	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened joint pain: Moderate	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened joint pain: Severe	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)
New or worsened joint pain: Grade 4	0 (0.0 to 41.0)	0 (0.0 to 45.9)	0 (0.0 to 45.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=5 to <12 Years ^[102] ^[103]

End point description

Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after vaccination.Fever:oral temperature >= 38.0 C;categorised as >=38.0 to 38.4 C, >38.4 to 38.9 C, >38.9 to 40.0 C and >40.0 degree C. Fatigue, headache,chills,new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity),moderate(some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe: required intravenous hydration. Diarrhea:mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours. Grade 4 for all events:ER visit/hospitalisation and were classified by investigator or medically qualified person.Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[102] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[103] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	12	19	15
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	6.7 (0.2 to 31.9)
Fever: >=38.0 to 38.4 deg C	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Fever: >38.4 to 38.9 deg C	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Fever: >38.9 to 40.0 deg C	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	6.7 (0.2 to 31.9)
Fever: >40.0 deg C	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Fatigue: Any	50.0 (21.1 to 78.9)	26.3 (9.1 to 51.2)	33.3 (11.8 to 61.6)
Fatigue: Mild	33.3 (9.9 to 65.1)	10.5 (1.3 to 33.1)	13.3 (1.7 to 40.5)
Fatigue: Moderate	16.7 (2.1 to 48.4)	15.8 (3.4 to 39.6)	20.0 (4.3 to 48.1)
Fatigue: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Fatigue: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Headache: Any	33.3 (9.9 to 65.1)	21.1 (6.1 to 45.6)	13.3 (1.7 to 40.5)
Headache: Mild	8.3 (0.2 to 38.5)	15.8 (3.4 to 39.6)	0 (0.0 to 21.8)
Headache: Moderate	25.0 (5.5 to 57.2)	5.3 (0.1 to 26.0)	6.7 (0.2 to 31.9)
Headache: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	6.7 (0.2 to 31.9)
Headache: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Chills: Any	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	13.3 (1.7 to 40.5)
Chills: Mild	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	0 (0.0 to 21.8)
Chills: Moderate	0 (0.0 to 26.5)	0 (0.0 to 17.6)	13.3 (1.7 to 40.5)
Chills: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Chills: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Vomiting: Any	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	0 (0.0 to 21.8)
Vomiting: Mild	8.3 (0.2 to 38.5)	5.3 (0.1 to 26.0)	0 (0.0 to 21.8)
Vomiting: Moderate	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Vomiting: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Vomiting: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Diarrhea: Any	25.0 (5.5 to 57.2)	15.8 (3.4 to 39.6)	6.7 (0.2 to 31.9)
Diarrhea: Mild	25.0 (5.5 to 57.2)	10.5 (1.3 to 33.1)	6.7 (0.2 to 31.9)
Diarrhea: Moderate	0 (0.0 to 26.5)	5.3 (0.1 to 26.0)	0 (0.0 to 21.8)
Diarrhea: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
Diarrhea: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
New or worsened muscle pain: Any	16.7 (2.1 to 48.4)	15.8 (3.4 to 39.6)	6.7 (0.2 to 31.9)
New or worsened muscle pain: Mild	0 (0.0 to 26.5)	15.8 (3.4 to 39.6)	0 (0.0 to 21.8)
New or worsened muscle pain: Moderate	8.3 (0.2 to 38.5)	0 (0.0 to 17.6)	6.7 (0.2 to 31.9)
New or worsened muscle pain: Severe	8.3 (0.2 to 38.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
New or worsened muscle pain: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
New or worsened joint pain: Any	25.0 (5.5 to 57.2)	0 (0.0 to 17.6)	6.7 (0.2 to 31.9)
New or worsened joint pain: Mild	8.3 (0.2 to 38.5)	0 (0.0 to 17.6)	6.7 (0.2 to 31.9)
New or worsened joint pain: Moderate	16.7 (2.1 to 48.4)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
New or worsened joint pain: Severe	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)
New or worsened joint pain: Grade 4	0 (0.0 to 26.5)	0 (0.0 to 17.6)	0 (0.0 to 21.8)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=12 to <18 Years ^[104] ^[105]

End point description

Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after vaccination.Fever: oral temperature >=38.0 C;categorised as >=38.0 to 38.4 C, >38.4 to 38.9 C, >38.9 to 40.0 C and >40.0 degree C. Fatigue,headache,chills,new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity),moderate (some interference with activity),severe (prevented daily routine activity).Vomiting:mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours,severe:required intravenous hydration:Diarrhea:mild: 2-3 loose stools in 24 hours,moderate: 4-5 loose stools in 24 hours,severe: 6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population. 'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[104] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[105] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	4	1	3
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Fever: >=38.0 to 38.4 deg C	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >38.4 to 38.9 deg C	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Fever: >38.9 to 40.0 deg C	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fever: >40.0 deg C	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fatigue: Any	50.0 (6.8 to 93.2)	100.0 (2.5 to 100.0)	66.7 (9.4 to 99.2)
Fatigue: Mild	0 (0.0 to 60.2)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Fatigue: Moderate	50.0 (6.8 to 93.2)	100.0 (2.5 to 100.0)	33.3 (0.8 to 90.6)
Fatigue: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Fatigue: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Any	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Headache: Mild	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Moderate	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Headache: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Headache: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Any	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Chills: Mild	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Chills: Moderate	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Chills: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Any	0 (0.0 to 60.2)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Vomiting: Mild	0 (0.0 to 60.2)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Vomiting: Moderate	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Vomiting: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Any	0 (0.0 to 60.2)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Diarrhea: Mild	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Moderate	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
Diarrhea: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
Diarrhea: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Any	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
New or worsened muscle pain: Mild	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Moderate	25.0 (0.6 to 80.6)	0 (0.0 to 97.5)	33.3 (0.8 to 90.6)
New or worsened muscle pain: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened muscle pain: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Any	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Mild	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Moderate	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Severe	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)
New or worsened joint pain: Grade 4	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=18 Years ^[106] ^[107]

End point description

Systemic events were recorded in e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after vaccination. Fever: oral temperature >=38.0 C;categorised as >=38.0 to 38.4 C, >38.4 to 38.9 C, >38.9 to 40.0 C and >40.0 C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild: 1-2 times in 24 hours, moderate: >2 times in 24 hours, severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe:6 or more loose stools in 24 hours. Grade 4 for all events: ER visit/hospitalisation and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method. Safety population.'N'= subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

Day 1 to Day 7 after Vaccination 4

Notes
[106] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[107] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	3	1	0 ^[108]
Units: Percentage of subjects
number (confidence interval 95%)
Fever: Any	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Fever: >=38.0 to 38.4 deg C	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Fever: >38.4 to 38.9 deg C	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Fever: >38.9 to 40.0 deg C	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Fever: >40.0 deg C	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Fatigue: Any	66.7 (9.4 to 99.2)	0 (0.0 to 97.5)	( to )
Fatigue: Mild	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Fatigue: Moderate	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Fatigue: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Fatigue: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Headache: Any	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Headache: Mild	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Headache: Moderate	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Headache: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Headache: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Chills: Any	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Chills: Mild	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Chills: Moderate	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
Chills: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Chills: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Vomiting: Any	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Vomiting: Mild	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Vomiting: Moderate	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Vomiting: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Vomiting: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Diarrhea: Any	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Diarrhea: Mild	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Diarrhea: Moderate	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Diarrhea: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
Diarrhea: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
New or worsened muscle pain: Any	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
New or worsened muscle pain: Mild	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
New or worsened muscle pain: Moderate	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
New or worsened muscle pain: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
New or worsened muscle pain: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
New or worsened joint pain: Any	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
New or worsened joint pain: Mild	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
New or worsened joint pain: Moderate	33.3 (0.8 to 90.6)	0 (0.0 to 97.5)	( to )
New or worsened joint pain: Severe	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )
New or worsened joint pain: Grade 4	0 (0.0 to 70.8)	0 (0.0 to 97.5)	( to )

Notes
[108] - No subjects were evaluable for this endpoint from this arm.

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=2 to <5 Years ^[109] ^[110]

End point description

An adverse event (AE) was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 1 to 1 month after Vaccination 2

Notes
[109] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[110] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	13
Units: Percentage of subjects
number (confidence interval 95%)	44.4 (13.7 to 78.8)	33.3 (11.8 to 61.6)	38.5 (13.9 to 68.4)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=5 to <12 Years ^[111] ^[112]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 1 to 1 month after Vaccination 2

Notes
[111] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[112] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	19	24	22
Units: Percentage of subjects
number (confidence interval 95%)	36.8 (16.3 to 61.6)	8.3 (1.0 to 27.0)	27.3 (0.7 to 50.2)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=5 to <12 Years ^[113] ^[114]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 3 to 1 month after vaccination 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 3 to 1 month after Vaccination 3

Notes
[113] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[114] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	17	23	22
Units: Percentage of subjects
number (confidence interval 95%)	29.4 (10.3 to 56.0)	8.7 (1.1 to 28.0)	4.5 (0.1 to 22.8)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=2 to <5 Years ^[115] ^[116]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 3 to 1 month after vaccination 3 were reported in this endpoint. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 3 to 1 month after Vaccination 3

Notes
[115] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[116] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	11
Units: Percentage of subjects
number (confidence interval 95%)	33.3 (7.5 to 70.1)	40.0 (16.3 to 67.7)	0 (0.0 to 28.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=12 to <18 Years ^[117] ^[118]

End point description

End point type

Primary

End point timeframe

From Vaccination 1 to 1 month after Vaccination 2

Notes
[117] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[118] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	7
Units: Percentage of subjects
number (confidence interval 95%)	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	14.3 (0.4 to 57.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 1 to 1 Month After Vaccination 2 in Subjects Aged >=18 Years ^[119] ^[120]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 1 to 1 month after vaccination 2 were reported in this endpoint. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 1 to 1 month after Vaccination 2

Notes
[119] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[120] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	5	1	1
Units: Percentage of subjects
number (confidence interval 95%)	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	0 (0.0 to 97.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=18 Years ^[121] ^[122]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 3 to 1 month after vaccination 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 3 to 1 month after Vaccination 3

Notes
[121] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[122] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	5	1	1
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 52.2)	0 (0.0 to 97.5)	0 (0.0 to 97.5)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=2 to <5 Years ^[123] ^[124]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 4 to 1 month after vaccination 4 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 4 to 1 month after Vaccination 4

Notes
[123] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[124] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	7	6	6
Units: Percentage of subjects
number (confidence interval 95%)	14.3 (0.4 to 57.9)	16.7 (0.4 to 64.1)	0 (0.0 to 45.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=5 to <12 Years ^[125] ^[126]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 4 to 1 month after vaccination 4 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 4 to 1 month after Vaccination 4

Notes
[125] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[126] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	12	19	15
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 26.5)	36.8 (16.3 to 61.6)	0 (0.0 to 21.8)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 3 to 1 Month After Vaccination 3 in Subjects Aged >=12 to <18 Years ^[127] ^[128]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 3 to 1 month after vaccination 3 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 3 to 1 month after Vaccination 3

Notes
[127] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[128] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	6
Units: Percentage of subjects
number (confidence interval 95%)	14.3 (0.4 to 57.9)	0 (0.0 to 97.5)	16.7 (0.4 to 64.1)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting SAEs From Vaccination 1 Through the Duration of the Study in Subjects Aged >=5 to <12 Years

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End point title

Percentage of Subjects Reporting SAEs From Vaccination 1 Through the Duration of the Study in Subjects Aged >=5 to <12 Years ^[129] ^[130]

End point description

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalisation or prolongation of existing hospitalisation, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, and other situations as medical judgement of investigator. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 1 to 6 month after Vaccination 4 (approximately 14 months)

Notes
[129] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[130] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	5 to <12 Years with Stem Cell Transplant
Number of subjects analysed	19	24	22
Units: Percentage of subjects
number (confidence interval 95%)	15.8 (3.4 to 39.6)	20.8 (7.1 to 42.2)	13.6 (2.9 to 34.9)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=12 to <18 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event From Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=12 to <18 Years ^[131] ^[132]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 4 to 1 month after vaccination 4 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 4 to 1 month after Vaccination 4

Notes
[131] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[132] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	4	1	3
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 60.2)	0 (0.0 to 97.5)	0 (0.0 to 70.8)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Subjects Aged >=2 to <5 Years

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End point title

Percentage of Subjects Reporting Serious Adverse Events (SAEs) From Vaccination 1 Through the Duration of the Study in Subjects Aged >=2 to <5 Years ^[133] ^[134]

End point description

End point type

Primary

End point timeframe

From Vaccination 1 to 6 month after Vaccination 4 (approximately 14 months)

Notes
[133] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[134] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	2 to <5 Years with Immunomodulatory Therapy	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant
Number of subjects analysed	9	15	13
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 33.6)	53.3 (26.6 to 78.7)	23.1 (5.0 to 53.8)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting at Least 1 Adverse Event After Vaccination 4 to 1 Month After Vaccination 4 in Subjects Aged >=18 Years ^[135] ^[136]

End point description

An AE was defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of subjects reporting AEs after vaccination 4 to 1 month after vaccination 4 were reported in this endpoint. Exact 2-sided CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this endpoint. Safety population included all subjects who received at least 1 dose of the study intervention.

End point type

Primary

End point timeframe

From Vaccination 4 to 1 month after Vaccination 4

Notes
[135] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[136] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	3	1	0 ^[137]
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 70.8)	100.0 (2.5 to 100.0)	( to )

Notes
[137] - No subjects were evaluable for this endpoint.

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting SAEs From Dose 1 Through the Duration of the Study in Subjects Aged >=18 Years

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End point title

Percentage of Subjects Reporting SAEs From Dose 1 Through the Duration of the Study in Subjects Aged >=18 Years ^[138] ^[139]

End point description

End point type

Primary

End point timeframe

From Vaccination 1 to 6 month after Vaccination 4 (approximately 14 months)

Notes
[138] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[139] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Number of subjects analysed	5	1	1
Units: Percentage of subjects
number (confidence interval 95%)	20.0 (0.5 to 71.6)	0 (0.0 to 97.5)	100.0 (2.5 to 100.0)

No statistical analyses for this end point

Primary: Percentage of Subjects Reporting SAEs From Vaccination 1 Through the Duration of the Study in Subjects Aged >=12 to <18 Years

Top of page

End point title

Percentage of Subjects Reporting SAEs From Vaccination 1 Through the Duration of the Study in Subjects Aged >=12 to <18 Years ^[140] ^[141]

End point description

End point type

Primary

End point timeframe

From Vaccination 1 to 6 month after Vaccination 4 (approximately 14 months)

Notes
[140] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was planned to be analysed only for the specified reporting arms. No statistical analyses were planned for this primary endpoint.
[141] - 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: This endpoint was planned to be analysed only for the specified reporting arms.

End point values	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant
Number of subjects analysed	7	1	7
Units: Percentage of subjects
number (confidence interval 95%)	0 (0.0 to 41.0)	0 (0.0 to 97.5)	0 (0.0 to 41.0)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

Local reactions/systemic events up to Day 7 each dose. AEs were reported from first dose of study treatment up to 1 month after last dose of study treatment (approximately 9 months). For SAE, from Dose 1 to 6 month after Dose 4 (approximately 14 months).

Adverse event reporting additional description

Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

26.0

Reporting group title

2 to < 5 Years with Solid Organ Transplant

Reporting group description

Reporting group title

2 to < 5 Years with Stem Cell Transplant

Reporting group description

Reporting group title

5 to <12 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

5 to <12 Years with Solid Organ Transplant

Reporting group description

Reporting group title

2 to <5 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

5 to <12 Years with Stem Cell Transplant

Reporting group description

Reporting group title

12 to <18 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

12 to <18 Years with Solid Organ Transplant

Reporting group description

Reporting group title

12 to <18 Years with Stem Cell Transplant

Reporting group description

Reporting group title

>=18 Years with Immunomodulatory Therapy

Reporting group description

Reporting group title

>=18 Years with Non-Small Cell Lung Cancer

Reporting group description

Reporting group title

>= 18 Years with Haemodialysis

Reporting group description

2 to < 5 Years with Solid Organ Transplant

2 to < 5 Years with Stem Cell Transplant

5 to <12 Years with Immunomodulatory Therapy

5 to <12 Years with Solid Organ Transplant

2 to <5 Years with Immunomodulatory Therapy

5 to <12 Years with Stem Cell Transplant

12 to <18 Years with Immunomodulatory Therapy

12 to <18 Years with Solid Organ Transplant

12 to <18 Years with Stem Cell Transplant

>=18 Years with Immunomodulatory Therapy

>=18 Years with Non-Small Cell Lung Cancer

>= 18 Years with Haemodialysis

Total subjects affected by serious adverse events

subjects affected / exposed

8 / 15 (53.33%)

3 / 13 (23.08%)

3 / 19 (15.79%)

5 / 24 (20.83%)

0 / 9 (0.00%)

3 / 22 (13.64%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

1 / 5 (20.00%)

0 / 1 (0.00%)

1 / 1 (100.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Vascular disorders

Hypertension

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Surgical and medical procedures

Catheter removal

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

1 / 22 (4.55%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Influenza like illness

subjects affected / exposed

1 / 15 (6.67%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 15 (0.00%)

1 / 13 (7.69%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Kidney transplant rejection

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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

Pulmonary vein stenosis

subjects affected / exposed

1 / 15 (6.67%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Arthropod sting

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

1 / 19 (5.26%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Postoperative ileus

subjects affected / exposed

1 / 15 (6.67%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Epilepsy

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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

Anaemia

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

1 / 19 (5.26%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Dental caries

subjects affected / exposed

0 / 15 (0.00%)

1 / 13 (7.69%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intestinal obstruction

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

1 / 19 (5.26%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Melaena

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

1 / 1 (100.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Dermatomyositis

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

1 / 19 (5.26%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Renal colic

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

1 / 5 (20.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Azotaemia

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

1 / 1 (100.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Acute kidney injury

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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

Myositis

subjects affected / exposed

1 / 15 (6.67%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Bronchiolitis

subjects affected / exposed

0 / 15 (0.00%)

1 / 13 (7.69%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Adenovirus infection

subjects affected / exposed

1 / 15 (6.67%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device related infection

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

1 / 22 (4.55%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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

2 / 15 (13.33%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gangrene

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

1 / 1 (100.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Epstein-Barr virus infection

subjects affected / exposed

1 / 15 (6.67%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Herpes zoster

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

1 / 22 (4.55%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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

2 / 15 (13.33%)

0 / 13 (0.00%)

1 / 19 (5.26%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rhinovirus infection

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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 infection

subjects affected / exposed

1 / 15 (6.67%)

0 / 13 (0.00%)

0 / 19 (0.00%)

0 / 24 (0.00%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Hyponatraemia

subjects affected / exposed

0 / 15 (0.00%)

0 / 13 (0.00%)

0 / 19 (0.00%)

1 / 24 (4.17%)

0 / 9 (0.00%)

0 / 22 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 7 (0.00%)

0 / 5 (0.00%)

0 / 1 (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: 1%

Non-serious adverse events	2 to < 5 Years with Solid Organ Transplant	2 to < 5 Years with Stem Cell Transplant	5 to <12 Years with Immunomodulatory Therapy	5 to <12 Years with Solid Organ Transplant	2 to <5 Years with Immunomodulatory Therapy	5 to <12 Years with Stem Cell Transplant	12 to <18 Years with Immunomodulatory Therapy	12 to <18 Years with Solid Organ Transplant	12 to <18 Years with Stem Cell Transplant	>=18 Years with Immunomodulatory Therapy	>=18 Years with Non-Small Cell Lung Cancer	>= 18 Years with Haemodialysis
Total subjects affected by non serious adverse events
subjects affected / exposed	13 / 15 (86.67%)	10 / 13 (76.92%)	18 / 19 (94.74%)	23 / 24 (95.83%)	8 / 9 (88.89%)	22 / 22 (100.00%)	7 / 7 (100.00%)	1 / 1 (100.00%)	6 / 7 (85.71%)	4 / 5 (80.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0
General disorders and administration site conditions
Fatigue (FATIGUE)
alternative assessment type: Systematic
subjects affected / exposed	3 / 15 (20.00%)	3 / 13 (23.08%)	14 / 19 (73.68%)	17 / 24 (70.83%)	3 / 9 (33.33%)	14 / 22 (63.64%)	6 / 7 (85.71%)	1 / 1 (100.00%)	5 / 7 (71.43%)	4 / 5 (80.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)
occurrences all number	3	3	34	31	4	31	18	2	10	11	2	1
Erythema (REDNESS)
alternative assessment type: Systematic
subjects affected / exposed	3 / 15 (20.00%)	0 / 13 (0.00%)	7 / 19 (36.84%)	5 / 24 (20.83%)	3 / 9 (33.33%)	6 / 22 (27.27%)	3 / 7 (42.86%)	0 / 1 (0.00%)	2 / 7 (28.57%)	1 / 5 (20.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	5	0	10	7	4	13	7	0	4	2	0	0
Chills (CHILLS)
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	1 / 13 (7.69%)	7 / 19 (36.84%)	3 / 24 (12.50%)	2 / 9 (22.22%)	5 / 22 (22.73%)	5 / 7 (71.43%)	1 / 1 (100.00%)	1 / 7 (14.29%)	2 / 5 (40.00%)	0 / 1 (0.00%)	1 / 1 (100.00%)
occurrences all number	1	1	9	3	2	7	10	1	2	5	0	1
Chills
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Chest pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Medical device site inflammation
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	2 / 15 (13.33%)	1 / 13 (7.69%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0	1	0	0	0
Injection site pain (PAIN AT INJECTION SITE)
alternative assessment type: Systematic
subjects affected / exposed	3 / 15 (20.00%)	4 / 13 (30.77%)	16 / 19 (84.21%)	18 / 24 (75.00%)	4 / 9 (44.44%)	19 / 22 (86.36%)	6 / 7 (85.71%)	1 / 1 (100.00%)	5 / 7 (71.43%)	4 / 5 (80.00%)	1 / 1 (100.00%)	1 / 1 (100.00%)
occurrences all number	6	4	50	43	6	40	20	4	12	13	3	1
Injection site pain
subjects affected / exposed	1 / 15 (6.67%)	1 / 13 (7.69%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	2	1	0	0	2	0	0	1	0	0	0
Injection site erythema
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Injection site bruising
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Pyrexia (FEVER)
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	2 / 13 (15.38%)	2 / 19 (10.53%)	2 / 24 (8.33%)	2 / 9 (22.22%)	5 / 22 (22.73%)	3 / 7 (42.86%)	0 / 1 (0.00%)	3 / 7 (42.86%)	1 / 5 (20.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	2	4	2	3	6	7	0	3	1	0	0
Swelling (SWELLING)
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	1 / 13 (7.69%)	5 / 19 (26.32%)	4 / 24 (16.67%)	1 / 9 (11.11%)	8 / 22 (36.36%)	2 / 7 (28.57%)	1 / 1 (100.00%)	2 / 7 (28.57%)	1 / 5 (20.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	1	8	6	2	17	8	1	3	2	0	0
Reproductive system and breast disorders
Breast enlargement
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Breast pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Cough
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Psychiatric disorders
Attention deficit hyperactivity disorder
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Investigations
Body temperature increased
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Blood iron decreased
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Donor specific antibody present
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Radius fracture
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Foreign body in eye
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Fall
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Skin abrasion
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	0	0
Congenital, familial and genetic disorders
Tumour necrosis factor receptor-associated periodic syndrome
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Cardiac disorders
Palpitations
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Nervous system disorders
Headache
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	4	0	0	0
Dizziness
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0
Headache (HEADACHE)
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	11 / 19 (57.89%)	11 / 24 (45.83%)	0 / 9 (0.00%)	9 / 22 (40.91%)	7 / 7 (100.00%)	1 / 1 (100.00%)	6 / 7 (85.71%)	4 / 5 (80.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	1	0	25	16	0	17	15	1	8	9	1	0
Blood and lymphatic system disorders
Neutropenia
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Lymphadenopathy
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Lymphadenitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Leukopenia
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Eye disorders
Amblyopia
subjects affected / exposed	0 / 15 (0.00%)	1 / 13 (7.69%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0
Eye inflammation
subjects affected / exposed	0 / 15 (0.00%)	1 / 13 (7.69%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0	0
Eye discharge
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Eye irritation
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Ocular discomfort
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Eye pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Photophobia
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Uveitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0	0
Abdominal pain
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	2 / 24 (8.33%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0
Gastritis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Diarrhoea
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	0
Dental caries
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Crohn's disease
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Vomiting (VOMITING)
alternative assessment type: Systematic
subjects affected / exposed	3 / 15 (20.00%)	4 / 13 (30.77%)	2 / 19 (10.53%)	4 / 24 (16.67%)	1 / 9 (11.11%)	1 / 22 (4.55%)	3 / 7 (42.86%)	0 / 1 (0.00%)	1 / 7 (14.29%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	4	4	2	5	1	1	3	0	1	0	0	0
Vomiting
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	2 / 24 (8.33%)	1 / 9 (11.11%)	2 / 22 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	2	1	2	0	0	0	0	0	0
Diarrhoea (DIARRHEA)
alternative assessment type: Systematic
subjects affected / exposed	3 / 15 (20.00%)	2 / 13 (15.38%)	5 / 19 (26.32%)	5 / 24 (20.83%)	2 / 9 (22.22%)	2 / 22 (9.09%)	2 / 7 (28.57%)	0 / 1 (0.00%)	2 / 7 (28.57%)	3 / 5 (60.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	4	2	8	5	2	4	3	0	5	6	2	0
Hepatobiliary disorders
Cholelithiasis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Dermatitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0
Purpura
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	1 / 19 (5.26%)	1 / 24 (4.17%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	1	1	0	0	0	0	0	0	0
Rash erythematous
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Synovitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Muscular weakness
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 5 (20.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Myalgia (NEW OR WORSENED MUSCLE PAIN)
alternative assessment type: Systematic
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	6 / 19 (31.58%)	8 / 24 (33.33%)	1 / 9 (11.11%)	3 / 22 (13.64%)	3 / 7 (42.86%)	1 / 1 (100.00%)	3 / 7 (42.86%)	2 / 5 (40.00%)	1 / 1 (100.00%)	0 / 1 (0.00%)
occurrences all number	1	0	10	10	1	3	9	1	6	5	1	0
Arthralgia (NEW OR WORSENED JOINT PAIN)
alternative assessment type: Systematic
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	4 / 19 (21.05%)	2 / 24 (8.33%)	1 / 9 (11.11%)	3 / 22 (13.64%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 7 (0.00%)	2 / 5 (40.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	10	2	1	3	4	0	0	5	0	0
Infections and infestations
Conjunctivitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	2 / 24 (8.33%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	2	0	1	0	0	0	0	0	0
Clostridium difficile colitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Dengue fever
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Cytomegalovirus viraemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0
Gastrointestinal infection
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	1 / 22 (4.55%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0
Impetigo
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Influenza
subjects affected / exposed	1 / 15 (6.67%)	1 / 13 (7.69%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0
Epstein-Barr viraemia
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Stoma site cellulitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Sinusitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Pharyngitis streptococcal
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Otitis media chronic
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	1 / 24 (4.17%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0
Otitis media
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	1 / 19 (5.26%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	1	0	0	0	0	0	0	0
Otitis externa
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	3 / 24 (12.50%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	3	0	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	3 / 15 (20.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	3 / 24 (12.50%)	0 / 9 (0.00%)	0 / 22 (0.00%)	1 / 7 (14.29%)	1 / 1 (100.00%)	0 / 7 (0.00%)	1 / 5 (20.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	0	0	6	0	0	2	1	0	1	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 5 (20.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Tracheitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0
Tooth infection
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Tonsillitis
subjects affected / exposed	1 / 15 (6.67%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0
Vulvovaginitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	0 / 9 (0.00%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	1 / 5 (20.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0
Viral sinusitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Viral rhinitis
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0
Viral rash
subjects affected / exposed	0 / 15 (0.00%)	0 / 13 (0.00%)	0 / 19 (0.00%)	0 / 24 (0.00%)	1 / 9 (11.11%)	0 / 22 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 7 (0.00%)	0 / 5 (0.00%)	0 / 1 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

24 Jun 2021

Amendment 1: Updated section 2.3- Added safety text indicating that no specific safety concerns were identified by subgroup analysis by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection.

05 Aug 2021

Amendment 2: Updated Section 2.3.1– Risk Assessment for subjects, Updated section 3: Added primary and exploratory safety, tolerability, and immune response objectives for the expanded cohort of subjects on active immunomodulator therapy.

21 Jan 2022

Amendment 4: Reduced the Visit 5 window for provision of Dose 3; Clarified that if Visit 4 and Visit 5 occur on the same day, duplicate procedures need not be conducted; Updated procedures to allow vaccination with the age-appropriate dose removed; immunogenicity blood collection at Visit 5 and Visit 6; Removed PBMC collection at Visit 5 and Visit 7.

13 Jan 2023

Amendment 5: Updated Sections 1.1 - Number of subjects in each group based on actual recruitment figures; Updated Sections 8.9.8, 8.9.9, 8.9.10: clarifying the requirements for study procedures after protocol amendment 4.

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

Clinical Trial Results: A phase 2b, open-label study to evaluate the safety, tolerability, and immunogenicity of vaccine candidate BNT162b2 in immunocompromised participants >=2 years of age.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 3 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=2 to <5 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=5 to <12 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged 12 to <18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: GMTs of SARS‑CoV‑2 Neutralizing Titers at 1 Month After Vaccination 4 in Subjects Aged >=18 Years Without Serological or Virological Evidence of Past SARS-CoV-2 Infection

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Local Reactions by Maximum Severity Within 7 Days After Vaccination 4 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 1 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 2 in Subjects Aged >=18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=2 to <5 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=5 to <12 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years

Primary: Percentage of Subjects Reporting Systemic Events by Maximum Severity Within 7 Days After Vaccination 3 in Subjects Aged >=12 to <18 Years

Clinical Trial Results:
A phase 2b, open-label study to evaluate the safety, tolerability, and immunogenicity of vaccine candidate BNT162b2 in immunocompromised participants >=2 years of age.