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Clinical Trial Results:
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine Given in A Series of 3 Infant Doses And 1 Toddler Dose in Infants in India and Taiwan

Summary
EudraCT number	2025-000542-25
Trial protocol	Outside EU/EEA
Global end of trial date	20 Sep 2025

Results information
Results version number	v1(current)
This version publication date	25 Jun 2026
First version publication date	25 Jun 2026
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

B7471024

ISRCTN number

US NCT number

NCT05512819

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

66 Hudson Boulevard East, New York, United States, NY 10001

Public contact

PfizerClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

PfizerClinicalTrials.gov Call Center, Pfizer Inc., 001 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

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

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

13 Jan 2026

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

20 Sep 2025

Was the trial ended prematurely?

Main objective of the trial

To describe the safety profile of the 20-valent pneumococcal conjugate vaccine (20vPnC) in healthy infants in India and Taiwan, separately by country. To describe the immunogenicity of 20vPnC in healthy infants in India after Dose 4.

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 Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials participants were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Sep 2022

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

India: 351

Country: Number of subjects enrolled

Taiwan: 190

Worldwide total number of subjects

541

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)

541

Children (2-11 years)

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

The study was conducted across India and Taiwan. A total of 541 participants (351: India and 190: Taiwan) were enrolled to receive 20vPnC or 13vPnC and one participant randomized to “India participants: 13vPnC” did not receive the vaccination.

Screening details

Data from 100 participants at a single study site were excluded from the analysis due to a quality event impacting that site. The exclusion of this data does not change the overall conclusions of the study regarding the benefit-risk profile of PCV20 or PCV13 in children.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Investigator, Subject

Are arms mutually exclusive

Yes

India participants: 20vPnC (Excluding Site 1012)

Arm description

Infants from India (Excluding Site 1012) aged 42 to 84 days at the time of enrolment were randomized to receive 4 doses of 0.5 5 milliliter (mL) of 20vPnC intramuscularly. Participants were administered infant doses (dose 1 to dose 3) at approximately 6, 10 and 14 weeks of age. Toddler dose (dose 4) was given at approximately 12 to 15 months of age.

Arm type

Experimental

Investigational medicinal product name

20vPnC

Investigational medicinal product code

PF-06482077

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants were administered 0.5 mL 20vPnC intramuscularly into the anterolateral thigh muscle of the left leg.

India participants: 13vPnC (Excluding Site 1012)

Arm description

Infants from India (Excluding Site 1012) aged 42 to 84 days at the time of enrolment were randomized to receive 4 doses of 0.5 mL of 13vPnC intramuscularly. Participants were administered infant doses (dose 1 to dose 3) at approximately 6, 10 and 14 weeks of age. Toddler dose (dose 4) was given at approximately 12 to 15 months of age.

Arm type

Active comparator

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants were administered 0.5 mL 13vPnC intramuscularly into the anterolateral thigh muscle of the left leg.

Taiwan participants: 20vPnC

Arm description

Infants from Taiwan aged 56 to 84 days at the time of enrolment were randomized to receive 4 doses of 0.5 mL of 20vPnC intramuscularly. Participants were administered infant doses (dose 1 to dose 3) at approximately 8, 16, and 24 weeks of age. Toddler dose (dose 4) was given at approximately 12 to 15 months of age.

Arm type

Experimental

Investigational medicinal product name

20vPnC

Investigational medicinal product code

PF-06482077

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants were administered 0.5 mL 20vPnC intramuscularly into the anterolateral thigh muscle of the left leg.

Taiwan participants: 13vPnC

Arm description

Infants from Taiwan aged 56 to 84 days at the time of enrolment were randomized to receive 4 doses of 0.5 mL of 13vPnC intramuscularly. Participants were administered infant doses (dose 1 to dose 3) at approximately 8, 16, and 24 weeks of age. Toddler dose (dose 4) was given at approximately 12 to 15 months of age.

Arm type

Active comparator

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Participants were administered 0.5 mL 13vPnC intramuscularly into the anterolateral thigh muscle of the left leg.

Number of subjects in period 1 ^[1]	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Started	125	125	94	96
Dose 1	125	125	94	96
Dose 2	121	120	93	96
Dose 3	121	120	92	96
Dose 4	118	108	90	94
Completed	117	107	89	93
Not completed	8	18	5	3
Physician decision	-	1	-	-
Adverse event, non-fatal	-	-	1	-
No longer met eligibility criteria	1	5	2	3
Lost to follow-up	2	4	-	-
Withdrawal by parent/guardian	3	3	2	-
Protocol deviation	2	5	-	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The total number of participants enrolled worldwide was 541, of whom 440 were included in the baseline period. Data from 100 participants at a single study site were excluded from the analysis due to a quality event affecting that site. Additionally, one participant randomized to the “India participants: 13vPnC” group did not receive the vaccination.

Baseline characteristics

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Reporting group title

India participants: 20vPnC (Excluding Site 1012)

Reporting group description

Reporting group title

India participants: 13vPnC (Excluding Site 1012)

Reporting group description

Reporting group title

Taiwan participants: 20vPnC

Reporting group description

Reporting group title

Taiwan participants: 13vPnC

Reporting group description

Reporting group values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC	Total
Number of subjects	125	125	94	96
Age Categorical
Units: Subjects
Age continuous
Units: days
arithmetic mean (standard deviation)	50.2 ( 7.24 )	50.9 ( 6.98 )	67.5 ( 4.79 )	67.3 ( 5.17 )	-
Gender categorical
Units: Subjects
Male	59	62	43	57	221
Female	66	63	51	39	219
Race
Units: Subjects
Asian	125	125	94	96	440
American Indian or Alaska Native	0	0	0	0	0
Black or African American	0	0	0	0	0
White	0	0	0	0	0
Not Reported	0	0	0	0	0
Ethnicity
Units: Subjects
Not Hispanic or Latino	125	125	94	96	440
Hispanic or Latino	0	0	0	0	0

End points

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Reporting group title

India participants: 20vPnC (Excluding Site 1012)

Reporting group description

Reporting group title

India participants: 13vPnC (Excluding Site 1012)

Reporting group description

Reporting group title

Taiwan participants: 20vPnC

Reporting group description

Reporting group title

Taiwan participants: 13vPnC

Reporting group description

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- India Participants (Excluding Site 1012) ^[1] ^[2]

End point description

Local reactions included redness, swelling and pain at the injection site and were recorded by parents/legal guardians of participants using an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units (mdu), where 1 mdu = 0.5 centimeter (cm). Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched [example: whimpered, winced, protested, or withdrew]), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). Any local reaction: any redness and swelling >0.0 cm and any pain at the injection site. 95% CI was based on Clopper and Pearson method. Safety population included all the participants who received at least 1 dose of the study intervention and had safety data assessed after any dose. 'Number of Participants Analyzed' = number of participants with any e-diary data reported after Dose 1.

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 1 (Day 1=day of Dose 1 administration)

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 summarized for specified reporting arms only.
[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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	124	125
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	8.9 (4.5 to 15.3)	9.6 (5.1 to 16.2)
Redness: Mild	5.6 (2.3 to 11.3)	8.0 (3.9 to 14.2)
Redness: Moderate	3.2 (0.9 to 8.1)	1.6 (0.2 to 5.7)
Redness: Severe	0 (0.0 to 2.9)	0 (0.0 to 2.9)
Swelling: Any	12.1 (6.9 to 19.2)	16.8 (10.7 to 24.5)
Swelling: Mild	5.6 (2.3 to 11.3)	12.0 (6.9 to 19.0)
Swelling: Moderate	6.5 (2.8 to 12.3)	4.8 (1.8 to 10.2)
Swelling: Severe	0 (0.0 to 2.9)	0 (0.0 to 2.9)
Pain at the injection site: Any	58.1 (48.9 to 66.9)	68.0 (59.1 to 76.1)
Pain at the injection site: Mild	33.9 (25.6 to 42.9)	40.0 (31.3 to 49.1)
Pain at the injection site: Moderate	23.4 (16.3 to 31.8)	26.4 (18.9 to 35.0)
Pain at the injection site: Severe	0.8 (0.0 to 4.4)	1.6 (0.2 to 5.7)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- Taiwan Participants

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- Taiwan Participants ^[3] ^[4]

End point description

Local reactions included redness, swelling and pain at the injection site and were recorded by parents/legal guardians of participants using an e-diary. Redness and swelling were measured and recorded in mdu, where 1 mdu = 0.5 cm. Redness and swelling were graded as mild (>0 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched [example: whimpered, winced, protested, or withdrew]), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). Any local reaction: any redness and swelling >0.0 cm and any pain at the injection site. 95% CI was based on Clopper and Pearson method. Safety population included all the participants who received at least 1 dose of the study intervention and had safety data assessed after any dose.

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 1 (Day 1=day of Dose 1 administration)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	94	96
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	17.0 (10.1 to 26.2)	15.6 (9.0 to 24.5)
Redness: Mild	13.8 (7.6 to 22.5)	12.5 (6.6 to 20.8)
Redness: Moderate	3.2 (0.7 to 9.0)	3.1 (0.6 to 8.9)
Redness: Severe	0 (0.0 to 3.8)	0 (0.0 to 3.8)
Swelling: Any	9.6 (4.5 to 17.4)	15.6 (9.0 to 24.5)
Swelling: Mild	9.6 (4.5 to 17.4)	12.5 (6.6 to 20.8)
Swelling: Moderate	0 (0.0 to 3.8)	3.1 (0.6 to 8.9)
Swelling: Severe	0 (0.0 to 3.8)	0 (0.0 to 3.8)
Pain at injection site: Any	19.1 (11.8 to 28.6)	17.7 (10.7 to 26.8)
Pain at injection site: Mild	13.8 (7.6 to 22.5)	9.4 (4.4 to 17.1)
Pain at injection site: Moderate	5.3 (1.7 to 12.0)	8.3 (3.7 to 15.8)
Pain at injection site: Severe	0 (0.0 to 3.8)	0 (0.0 to 3.8)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- India Participants (Excluding Site 1012) ^[5] ^[6]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 2 (Day 1=day of Dose 2 administration)

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	121	120
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	5.8 (2.4 to 11.6)	8.3 (4.1 to 14.8)
Redness: Mild	4.1 (1.4 to 9.4)	8.3 (4.1 to 14.8)
Redness: Moderate	1.7 (0.2 to 5.8)	0 (0.0 to 3.0)
Redness: Severe	0 (0.0 to 3.0)	0 (0.0 to 3.0)
Swelling: Any	13.2 (7.8 to 20.6)	16.7 (10.5 to 24.6)
Swelling: Mild	8.3 (4.0 to 14.7)	13.3 (7.8 to 20.7)
Swelling: Moderate	5.0 (1.8 to 10.5)	3.3 (0.9 to 8.3)
Swelling: Severe	0 (0.0 to 3.0)	0 (0.0 to 3.0)
Pain at the injection site: Any	50.4 (41.2 to 59.6)	56.7 (47.3 to 65.7)
Pain at the injection site: Mild	32.2 (24.0 to 41.3)	35.0 (26.5 to 44.2)
Pain at the injection site: Moderate	18.2 (11.8 to 26.2)	21.7 (14.7 to 30.1)
Pain at the injection site: Severe	0 (0.0 to 3.0)	0 (0.0 to 3.0)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- Taiwan Participants

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- Taiwan Participants ^[7] ^[8]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 2 (Day 1=day of Dose 2 administration)

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[8] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	93	96
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	29.0 (20.1 to 39.4)	25.0 (16.7 to 34.9)
Redness: Mild	24.7 (16.4 to 34.8)	16.7 (9.8 to 25.6)
Redness: Moderate	4.3 (1.2 to 10.6)	7.3 (3.0 to 14.4)
Redness: Severe	0 (0.0 to 3.9)	1.0 (0.0 to 5.7)
Swelling: Any	24.7 (16.4 to 34.8)	22.9 (15.0 to 32.6)
Swelling: Mild	19.4 (11.9 to 28.9)	15.6 (9.0 to 24.5)
Swelling: Moderate	5.4 (1.8 to 12.1)	7.3 (3.0 to 14.4)
Swelling: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)
Pain at injection site: Any	23.7 (15.5 to 33.6)	22.9 (15.0 to 32.6)
Pain at injection site: Mild	17.2 (10.2 to 26.4)	13.5 (7.4 to 22.0)
Pain at injection site: Moderate	6.5 (2.4 to 13.5)	9.4 (4.4 to 17.1)
Pain at injection site: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- India Participants (Excluding Site 1012) ^[9] ^[10]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 3 (Day 1=day of Dose 3 administration)

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	118	120
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	8.5 (4.1 to 15.0)	9.2 (4.7 to 15.8)
Redness: Mild	6.8 (3.0 to 12.9)	7.5 (3.5 to 13.8)
Redness: Moderate	1.7 (0.2 to 6.0)	1.7 (0.2 to 5.9)
Redness: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.0)
Swelling: Any	15.3 (9.3 to 23.0)	9.2 (4.7 to 15.8)
Swelling: Mild	9.3 (4.7 to 16.1)	5.0 (1.9 to 10.6)
Swelling: Moderate	5.9 (2.4 to 11.8)	4.2 (1.4 to 9.5)
Swelling: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.0)
Pain at the injection site: Any	49.2 (39.8 to 58.5)	50.0 (40.7 to 59.3)
Pain at the injection site: Mild	38.1 (29.4 to 47.5)	32.5 (24.2 to 41.7)
Pain at the injection site: Moderate	11.0 (6.0 to 18.1)	17.5 (11.2 to 25.5)
Pain at the injection site: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.0)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- Taiwan Participants

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- Taiwan Participants ^[11] ^[12]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 3 (Day 1=day of Dose 3 administration)

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 summarized for specified reporting arms only.
[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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	92	96
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	26.1 (17.5 to 36.3)	24.0 (15.8 to 33.7)
Redness: Mild	19.6 (12.0 to 29.1)	17.7 (10.7 to 26.8)
Redness: Moderate	6.5 (2.4 to 13.7)	6.3 (2.3 to 13.1)
Redness: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)
Swelling: Any	21.7 (13.8 to 31.6)	30.2 (21.3 to 40.4)
Swelling: Mild	14.1 (7.7 to 23.0)	22.9 (15.0 to 32.6)
Swelling: Moderate	7.6 (3.1 to 15.1)	7.3 (3.0 to 14.4)
Swelling: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)
Pain at injection site: Any	17.4 (10.3 to 26.7)	22.9 (15.0 to 32.6)
Pain at injection site: Mild	14.1 (7.7 to 23.0)	16.7 (9.8 to 25.6)
Pain at injection site: Moderate	3.3 (0.7 to 9.2)	6.3 (2.3 to 13.1)
Pain at injection site: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- India Participants (Excluding Site 1012) ^[13] ^[14]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 4 (Day 1=day of Dose 4 administration)

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	118	108
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	0.8 (0.0 to 4.6)	5.6 (2.1 to 11.7)
Redness: Mild	0 (0.0 to 3.1)	4.6 (1.5 to 10.5)
Redness: Moderate	0.8 (0.0 to 4.6)	0.9 (0.0 to 5.1)
Redness: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.4)
Swelling: Any	2.5 (0.5 to 7.3)	4.6 (1.5 to 10.5)
Swelling: Mild	1.7 (0.2 to 6.0)	3.7 (1.0 to 9.2)
Swelling: Moderate	0.8 (0.0 to 4.6)	0.9 (0.0 to 5.1)
Swelling: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.4)
Pain at the injection site: Any	32.2 (23.9 to 41.4)	35.2 (26.2 to 45.0)
Pain at the injection site: Mild	25.4 (17.9 to 34.3)	30.6 (22.1 to 40.2)
Pain at the injection site: Moderate	6.8 (3.0 to 12.9)	4.6 (1.5 to 10.5)
Pain at the injection site: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.4)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- Taiwan Participants

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End point title

Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- Taiwan Participants ^[15] ^[16]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 4 (Day 1=day of Dose 4 administration)

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint was summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	90	94
Units: Percentage of participants
number (confidence interval 95%)
Redness: Any	23.3 (15.1 to 33.4)	17.0 (10.1 to 26.2)
Redness: Mild	11.1 (5.5 to 19.5)	12.8 (6.8 to 21.2)
Redness: Moderate	12.2 (6.3 to 20.8)	4.3 (1.2 to 10.5)
Redness: Severe	0 (0.0 to 4.0)	0 (0.0 to 3.8)
Swelling: Any	27.8 (18.9 to 38.2)	18.1 (10.9 to 27.4)
Swelling: Mild	14.4 (7.9 to 23.4)	16.0 (9.2 to 25.0)
Swelling: Moderate	13.3 (7.1 to 22.1)	2.1 (0.3 to 7.5)
Swelling: Severe	0 (0.0 to 4.0)	0 (0.0 to 3.8)
Pain at injection site: Any	22.2 (14.1 to 32.2)	12.8 (6.8 to 21.2)
Pain at injection site: Mild	20.0 (12.3 to 29.8)	11.7 (6.0 to 20.0)
Pain at injection site: Moderate	2.2 (0.3 to 7.8)	1.1 (0.0 to 5.8)
Pain at injection site: Severe	0 (0.0 to 4.0)	0 (0.0 to 3.8)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- India Participants (Excluding Site 1012) ^[17] ^[18]

End point description

Systemic events were recorded by parents/legal guardians of participant's using an e-diary. Fever= temperature >= 38.0 degree Celsius (deg C) and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed. Drowsiness/increased sleep was graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Any systemic event: any fever >=38 deg C, any decreased appetite, any drowsiness, any irritability. 95% CI based on Clopper and Pearson method. Safety population was used. Number of Participants Analyzed=number of participants with any e-diary data reported after Dose 1.

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 1 (Day 1=day of Dose 1 administration)

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[18] - 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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	124	125
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	18.5 (12.1 to 26.5)	15.2 (9.4 to 22.7)
Fever: >=38.0 deg C to 38.4 deg C	13.7 (8.2 to 21.0)	8.8 (4.5 to 15.2)
Fever: >38.4 deg C to 38.9 deg C	3.2 (0.9 to 8.1)	5.6 (2.3 to 11.2)
Fever: >38.9 deg C to 40.0 deg C	1.6 (0.2 to 5.7)	0.8 (0.0 to 4.4)
Fever: >40.0 deg C	0 (0.0 to 2.9)	0 (0.0 to 2.9)
Decreased appetite: Any	21.8 (14.9 to 30.1)	24.8 (17.5 to 33.3)
Decreased appetite: Mild	14.5 (8.8 to 22.0)	15.2 (9.4 to 22.7)
Decreased appetite: Moderate	7.3 (3.4 to 13.3)	7.2 (3.3 to 13.2)
Decreased appetite: Severe	0 (0.0 to 2.9)	2.4 (0.5 to 6.9)
Drowsiness: Any	32.3 (24.1 to 41.2)	33.6 (25.4 to 42.6)
Drowsiness: Mild	15.3 (9.5 to 22.9)	12.8 (7.5 to 20.0)
Drowsiness: Moderate	16.1 (10.1 to 23.8)	19.2 (12.7 to 27.2)
Drowsiness: Severe	0.8 (0.0 to 4.4)	1.6 (0.2 to 5.7)
Irritability: Any	66.1 (57.1 to 74.4)	67.2 (58.2 to 75.3)
Irritability: Mild	36.3 (27.8 to 45.4)	41.6 (32.9 to 50.8)
Irritability: Moderate	28.2 (20.5 to 37.0)	23.2 (16.1 to 31.6)
Irritability: Severe	1.6 (0.2 to 5.7)	2.4 (0.5 to 6.9)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- Taiwan Participants

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- Taiwan Participants ^[19] ^[20]

End point description

Systemic events were recorded by parents/legal guardians of participant's using an e-diary. Fever= temperature >= 38.0 deg C and categorized as >=38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake and severe: refusal to feed. Drowsiness/increased sleep was graded as mild: increased or prolonged sleeping bouts, moderate: slightly subdued, interfered with daily activity and severe: disabling, not interested in usual daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention and severe: inconsolable, crying could not be comforted. Any systemic event: any fever >=38 deg C, any decreased appetite, any drowsiness, any irritability. 95% CI based on Clopper and Pearson method. Safety population was used.

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 1 (Day 1=day of Dose 1 administration)

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[20] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	94	96
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	4.3 (1.2 to 10.5)	6.3 (2.3 to 13.1)
Fever: >=38.0 deg C to 38.4 deg C	2.1 (0.3 to 7.5)	5.2 (1.7 to 11.7)
Fever: >38.4 deg C to 38.9 deg C	2.1 (0.3 to 7.5)	1.0 (0.0 to 5.7)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 3.8)	0 (0.0 to 3.8)
Fever: >40.0 deg C	0 (0.0 to 3.8)	0 (0.0 to 3.8)
Decreased appetite: Any	31.9 (22.7 to 42.3)	28.1 (19.4 to 38.2)
Decreased appetite: Mild	10.6 (5.2 to 18.7)	12.5 (6.6 to 20.8)
Decreased appetite: Moderate	21.3 (13.5 to 30.9)	14.6 (8.2 to 23.3)
Decreased appetite: Severe	0 (0.0 to 3.8)	1.0 (0.0 to 5.7)
Drowsiness: Any	52.1 (41.6 to 62.5)	47.9 (37.6 to 58.4)
Drowsiness: Mild	44.7 (34.4 to 55.3)	42.7 (32.7 to 53.2)
Drowsiness: Moderate	7.4 (3.0 to 14.7)	4.2 (1.1 to 10.3)
Drowsiness: Severe	0 (0.0 to 3.8)	1.0 (0.0 to 5.7)
Irritability: Any	42.6 (32.4 to 53.2)	40.6 (30.7 to 51.1)
Irritability: Mild	14.9 (8.4 to 23.7)	13.5 (7.4 to 22.0)
Irritability: Moderate	22.3 (14.4 to 32.1)	25.0 (16.7 to 34.9)
Irritability: Severe	5.3 (1.7 to 12.0)	2.1 (0.3 to 7.3)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- India Participants (Excluding Site 1012) ^[21] ^[22]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 2 (Day 1=day of Dose 2 administration)

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 summarized for specified reporting arms only.
[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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	121	120
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	11.6 (6.5 to 18.7)	9.2 (4.7 to 15.8)
Fever: >=38.0 deg C to 38.4 deg C	9.9 (5.2 to 16.7)	5.8 (2.4 to 11.6)
Fever: >38.4 deg C to 38.9 deg C	0.8 (0.0 to 4.5)	2.5 (0.5 to 7.1)
Fever: >38.9 deg C to 40.0 deg C	0.8 (0.0 to 4.5)	0.8 (0.0 to 4.6)
Fever: >40.0 deg C	0 (0.0 to 3.0)	0 (0.0 to 3.0)
Decreased appetite: Any	13.2 (7.8 to 20.6)	15.8 (9.8 to 23.6)
Decreased appetite: Mild	6.6 (2.9 to 12.6)	13.3 (7.8 to 20.7)
Decreased appetite: Moderate	6.6 (2.9 to 12.6)	2.5 (0.5 to 7.1)
Decreased appetite: Severe	0 (0.0 to 3.0)	0.0 (0.0 to 3.0)
Drowsiness: Any	21.5 (14.5 to 29.9)	18.3 (11.9 to 26.4)
Drowsiness: Mild	14.0 (8.4 to 21.5)	13.3 (7.8 to 20.7)
Drowsiness: Moderate	7.4 (3.5 to 13.7)	5.0 (1.9 to 10.6)
Drowsiness: Severe	0 (0.0 to 3.0)	0 (0.0 to 3.0)
Irritability: Any	54.5 (45.2 to 63.6)	50.0 (40.7 to 59.3)
Irritability: Mild	35.5 (27.0 to 44.8)	29.2 (21.2 to 38.2)
Irritability: Moderate	18.2 (11.8 to 26.2)	20.8 (14.0 to 29.2)
Irritability: Severe	0.8 (0.0 to 4.5)	0 (0.0 to 3.0)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- Taiwan Participants

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- Taiwan Participants ^[23] ^[24]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 2 (Day 1=day of Dose 2 administration)

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[24] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	93	96
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	15.1 (8.5 to 24.0)	11.5 (5.9 to 19.6)
Fever: >=38.0 deg C to 38.4 deg C	8.6 (3.8 to 16.2)	8.3 (3.7 to 15.8)
Fever: >38.4 deg C to 38.9 deg C	4.3 (1.2 to 10.6)	2.1 (0.3 to 7.3)
Fever: >38.9 deg C to 40.0 deg C	1.1 (0.0 to 5.8)	1.0 (0.0 to 5.7)
Fever: >40.0 deg C	1.1 (0.0 to 5.8)	0 (0.0 to 3.8)
Decreased appetite: Any	36.6 (26.8 to 47.2)	30.2 (21.3 to 40.4)
Decreased appetite: Mild	21.5 (13.7 to 31.2)	8.3 (3.7 to 15.8)
Decreased appetite: Moderate	14.0 (7.7 to 22.7)	21.9 (14.1 to 31.5)
Decreased appetite: Severe	1.1 (0.0 to 5.8)	0 (0.0 to 3.8)
Drowsiness: Any	48.4 (37.9 to 59.0)	50.0 (39.6 to 60.4)
Drowsiness: Mild	40.9 (30.8 to 51.5)	43.8 (33.6 to 54.3)
Drowsiness: Moderate	7.5 (3.1 to 14.9)	6.3 (2.3 to 13.1)
Drowsiness: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)
Irritability: Any	43.0 (32.8 to 53.7)	46.9 (36.6 to 57.3)
Irritability: Mild	14.0 (7.7 to 22.7)	11.5 (5.9 to 19.6)
Irritability: Moderate	25.8 (17.3 to 35.9)	31.3 (22.2 to 41.5)
Irritability: Severe	3.2 (0.7 to 9.1)	4.2 (1.1 to 10.3)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- India Participants (Excluding Site 1012) ^[25] ^[26]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 3 (Day 1=day of Dose 3 administration)

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[26] - 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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	118	120
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	2.5 (0.5 to 7.3)	3.3 (0.9 to 8.3)
Fever: >=38.0 deg C to 38.4 deg C	1.7 (0.2 to 6.0)	2.5 (0.5 to 7.1)
Fever: >38.4 deg C to 38.9 deg C	0.8 (0.0 to 4.6)	0.8 (0.0 to 4.6)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 3.1)	0 (0.0 to 3.0)
Fever: >40.0 deg C	0 (0.0 to 3.1)	0 (0.0 to 3.0)
Decreased appetite: Any	10.2 (5.4 to 17.1)	10.8 (5.9 to 17.8)
Decreased appetite: Mild	7.6 (3.5 to 14.0)	9.2 (4.7 to 15.8)
Decreased appetite: Moderate	2.5 (0.5 to 7.3)	1.7 (0.2 to 5.9)
Decreased appetite: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.0)
Drowsiness: Any	20.3 (13.5 to 28.7)	11.7 (6.5 to 18.8)
Drowsiness: Mild	14.4 (8.6 to 22.1)	6.7 (2.9 to 12.7)
Drowsiness: Moderate	5.9 (2.4 to 11.8)	5.0 (1.9 to 10.6)
Drowsiness: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.0)
Irritability: Any	46.6 (37.4 to 56.0)	49.2 (39.9 to 58.4)
Irritability: Mild	30.5 (22.4 to 39.7)	34.2 (25.8 to 43.4)
Irritability: Moderate	15.3 (9.3 to 23.0)	15.0 (9.1 to 22.7)
Irritability: Severe	0.8 (0.0 to 4.6)	0 (0.0 to 3.0)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- Taiwan Participants

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- Taiwan Participants ^[27] ^[28]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 3 (Day 1=day of Dose 3 administration)

Notes
[27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[28] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	92	96
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	7.6 (3.1 to 15.1)	13.5 (7.4 to 22.0)
Fever: >=38.0 deg C to 38.4 deg C	4.3 (1.2 to 10.8)	8.3 (3.7 to 15.8)
Fever: >38.4 deg C to 38.9 deg C	3.3 (0.7 to 9.2)	3.1 (0.6 to 8.9)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 3.9)	2.1 (0.3 to 7.3)
Fever: >40.0 deg C	0 (0.0 to 3.9)	0 (0.0 to 3.8)
Decreased appetite: Any	23.9 (15.6 to 33.9)	26.0 (17.6 to 36.0)
Decreased appetite: Mild	16.3 (9.4 to 25.5)	12.5 (6.6 to 20.8)
Decreased appetite: Moderate	7.6 (3.1 to 15.1)	13.5 (7.4 to 22.0)
Decreased appetite: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)
Drowsiness: Any	35.9 (26.1 to 46.5)	37.5 (27.8 to 48.0)
Drowsiness: Mild	31.5 (22.2 to 42.0)	30.2 (21.3 to 40.4)
Drowsiness: Moderate	4.3 (1.2 to 10.8)	7.3 (3.0 to 14.4)
Drowsiness: Severe	0 (0.0 to 3.9)	0 (0.0 to 3.8)
Irritability: Any	41.3 (31.1 to 52.1)	38.5 (28.8 to 49.0)
Irritability: Mild	14.1 (7.7 to 23.0)	9.4 (4.4 to 17.1)
Irritability: Moderate	25.0 (16.6 to 35.1)	28.1 (19.4 to 38.2)
Irritability: Severe	2.2 (0.3 to 7.6)	1.0 (0.0 to 5.7)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4- India Participants (Excluding Site 1012) ^[29] ^[30]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 4 (Day 1=day of Dose 4 administration)

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[30] - 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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	118	108
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	1.7 (0.2 to 6.0)	2.8 (0.6 to 7.9)
Fever: >=38.0 deg C to 38.4 deg C	0.8 (0.0 to 4.6)	0.9 (0.0 to 5.1)
Fever: >38.4 deg C to 38.9 deg C	0.8 (0.0 to 4.6)	0.9 (0.0 to 5.1)
Fever: >38.9 deg C to 40.0 deg C	0 (0.0 to 3.1)	0.9 (0.0 to 5.1)
Fever: >40.0 deg C	0 (0.0 to 3.1)	0 (0.0 to 3.4)
Decreased appetite: Any	8.5 (4.1 to 15.0)	10.2 (5.2 to 17.5)
Decreased appetite: Mild	5.9 (2.4 to 11.8)	5.6 (2.1 to 11.7)
Decreased appetite: Moderate	2.5 (0.5 to 7.3)	4.6 (1.5 to 10.5)
Decreased appetite: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.4)
Drowsiness: Any	6.8 (3.0 to 12.9)	6.5 (2.6 to 12.9)
Drowsiness: Mild	5.1 (1.9 to 10.7)	3.7 (1.0 to 9.2)
Drowsiness: Moderate	1.7 (0.2 to 6.0)	2.8 (0.6 to 7.9)
Drowsiness: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.4)
Irritability: Any	18.6 (12.1 to 26.9)	19.4 (12.5 to 28.2)
Irritability: Mild	15.3 (9.3 to 23.0)	12.0 (6.6 to 19.7)
Irritability: Moderate	3.4 (0.9 to 8.5)	7.4 (3.3 to 14.1)
Irritability: Severe	0 (0.0 to 3.1)	0 (0.0 to 3.4)

No statistical analyses for this end point

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4-Taiwan Participants

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End point title

Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4-Taiwan Participants ^[31] ^[32]

End point description

End point type

Primary

End point timeframe

From Day 1 through Day 7 after Dose 4 (Day 1=day of Dose 4 administration)

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 summarized for specified reporting arms only.
[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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	90	94
Units: Percentage of participants
number (confidence interval 95%)
Fever: >=38.0 deg C	15.6 (8.8 to 24.7)	13.8 (7.6 to 22.5)
Fever: >=38.0 deg C to 38.4 deg C	7.8 (3.2 to 15.4)	8.5 (3.7 to 16.1)
Fever: >38.4 deg C to 38.9 deg C	6.7 (2.5 to 13.9)	4.3 (1.2 to 10.5)
Fever: >38.9 deg C to 40.0 deg C	1.1 (0.0 to 6.0)	1.1 (0.0 to 5.8)
Fever: >40.0 deg C	0 (0.0 to 4.0)	0 (0.0 to 3.8)
Decreased appetite: Any	20.0 (12.3 to 29.8)	20.2 (12.6 to 29.8)
Decreased appetite: Mild	7.8 (3.2 to 15.4)	11.7 (6.0 to 20.0)
Decreased appetite: Moderate	12.2 (6.3 to 20.8)	7.4 (3.0 to 14.7)
Decreased appetite: Severe	0 (0.0 to 4.0)	1.1 (0.0 to 5.8)
Drowsiness: Any	23.3 (15.1 to 33.4)	33.0 (23.6 to 43.4)
Drowsiness: Mild	21.1 (13.2 to 31.0)	27.7 (18.9 to 37.8)
Drowsiness: Moderate	2.2 (0.3 to 7.8)	5.3 (1.7 to 12.0)
Drowsiness: Severe	0 (0.0 to 4.0)	0 (0.0 to 3.8)
Irritability: Any	31.1 (21.8 to 41.7)	35.1 (25.5 to 45.6)
Irritability: Mild	14.4 (7.9 to 23.4)	19.1 (11.8 to 28.6)
Irritability: Moderate	16.7 (9.6 to 26.0)	13.8 (7.6 to 22.5)
Irritability: Severe	0 (0.0 to 4.0)	2.1 (0.3 to 7.5)

No statistical analyses for this end point

Primary: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3- India Participants (Excluding Site 1012) ^[33] ^[34]

End point description

An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. 95% CI was 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 outcome measure. Safety population included all participants who received at least 1 dose of the study intervention and had safety data assessed after any dose.

End point type

Primary

End point timeframe

From Day 1 of Dose 1 to 1 Month After Dose 3

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[34] - 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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	125	125
Units: Percentage of participants
number (confidence interval 95%)	16.8 (10.7 to 24.5)	22.4 (15.4 to 30.7)

No statistical analyses for this end point

Primary: Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 3- Taiwan Participants

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End point title

Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 3- Taiwan Participants ^[35] ^[36]

End point description

End point type

Primary

End point timeframe

From Day 1 of Dose 1 to 1 Month After Dose 3

Notes
[35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[36] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	94	96
Units: Percentage of participants
number (confidence interval 95%)	46.8 (36.4 to 57.4)	45.8 (35.6 to 56.3)

No statistical analyses for this end point

Primary: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- India Participants (Excluding Site 1012) ^[37] ^[38]

End point description

End point type

Primary

End point timeframe

From Day 1 of Dose 4 to 1 month after Dose 4

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[38] - 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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	118	108
Units: Percentage of participants
number (confidence interval 95%)	6.8 (3.0 to 12.9)	3.7 (1.0 to 9.2)

No statistical analyses for this end point

Primary: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- Taiwan Participants

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End point title

Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- Taiwan Participants ^[39] ^[40]

End point description

End point type

Primary

End point timeframe

From Day 1 of Dose 4 to 1 month after Dose 4

Notes
[39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This endpoint was summarized for specified reporting arms only.
[40] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	90	94
Units: Percentage of participants
number (confidence interval 95%)	12.2 (6.3 to 20.8)	17.0 (10.1 to 26.2)

No statistical analyses for this end point

Primary: Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 4- Taiwan Participants

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End point title

Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 4- Taiwan Participants ^[41] ^[42]

End point description

An SAE was any untoward medical occurrence that, at any dose met at least of the following criteria: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. Safety population included all participants who received at least 1 dose of the study intervention and had safety data assessed after any dose.

End point type

Primary

End point timeframe

From Day 1 of Dose 1 to 1 month after Dose 4

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 summarized for specified reporting arms only.
[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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	94	96
Units: Percentage of participants
number (confidence interval 95%)	19.1 (11.8 to 28.6)	12.5 (6.6 to 20.8)

No statistical analyses for this end point

Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4- India Participants (Excluding Site 1012) ^[43] ^[44]

End point description

End point type

Primary

End point timeframe

From Day 1 of Dose 1 to 1 month after Dose 4

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 summarized for specified reporting arms only.
[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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	125	125
Units: Percentage of participants
number (confidence interval 95%)	0 (0.0 to 2.9)	1.6 (0.2 to 5.7)

No statistical analyses for this end point

Primary: Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) Serotypes at 1 Month After Dose 4- India Participants Only (Excluding Site 1012)

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End point title

Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) Serotypes at 1 Month After Dose 4- India Participants Only (Excluding Site 1012) ^[45] ^[46]

End point description

Concentrations of IgG for 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined by multiplex Luminex immunoassay. GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of concentrations and corresponding CIs based on Student's t distribution. Assay results below lower limit of quantification (LLOQ) was set to 0.5*LLOQ. Dose 4 evaluable immunogenicity population: eligible participants with specified age on day of Dose 1 and who received all 4 randomized vaccinations with Dose 4 received within 365-455 days of age, had at least 1 valid immunogenicity result after Dose 4, had blood collection within 27 to 56 days after Dose 4, had no other major protocol deviations as determined by the clinician. Number of Participants Analyzed=participants evaluable for this outcome measure and n= number of participants with valid IgG concentrations for the specified serotype at 1 month after Dose 4.

End point type

Primary

End point timeframe

1 Month After Dose 4

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 summarized for specified reporting arms only.
[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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	112	104
Units: Microgram per milliliter
geometric mean (confidence interval 95%)
Serotype 1 (n= 112,104)	3.31 (2.76 to 3.98)	5.05 (4.26 to 5.98)
Serotype 3 (n= 112,104)	1.19 (1.00 to 1.40)	1.83 (1.56 to 2.14)
Serotype 4 (n= 112,104)	8.80 (7.21 to 10.74)	12.21 (10.12 to 14.74)
Serotype 5 (n= 112,104)	3.74 (3.10 to 4.52)	6.01 (5.10 to 7.09)
Serotype 6A (n= 112,104)	13.65 (10.83 to 17.20)	23.45 (19.50 to 28.19)
Serotype 6B (n= 112,104)	7.84 (6.30 to 9.74)	13.65 (11.20 to 16.64)
Serotype 7F (n= 112,104)	5.35 (4.59 to 6.23)	7.03 (6.06 to 8.16)
Serotype 9V (n= 112,104)	5.53 (4.35 to 7.03)	7.36 (5.95 to 9.09)
Serotype 14 (n= 112,104)	10.30 (8.04 to 13.21)	13.51 (10.60 to 17.23)
Serotype 18C (n= 112,104)	5.07 (4.29 to 5.99)	6.38 (5.33 to 7.63)
Serotype 19A (n= 112,104)	8.66 (6.93 to 10.81)	11.87 (10.08 to 13.97)
Serotype 19F (n= 111,104)	11.18 (9.05 to 13.82)	17.96 (14.85 to 21.72)
Serotype 23F (n= 112,104)	5.26 (4.16 to 6.65)	8.31 (6.54 to 10.57)
Serotype 8 (n= 112,104)	6.76 (5.29 to 8.64)	0.14 (0.10 to 0.20)
Serotype 10A (n= 112,104)	7.24 (5.70 to 9.21)	0.03 (0.02 to 0.05)
Serotype 11A (n= 112,104)	4.90 (3.84 to 6.24)	0.04 (0.03 to 0.06)
Serotype 12F (n= 112,104)	2.86 (2.30 to 3.55)	0.02 (0.01 to 0.02)
Serotype 15B (n= 112,104)	17.92 (13.27 to 24.20)	0.05 (0.04 to 0.07)
Serotype 22F (n= 112,104)	9.50 (6.87 to 13.15)	0.03 (0.02 to 0.05)
Serotype 33F (n= 112,104)	11.69 (9.30 to 14.70)	0.04 (0.03 to 0.07)

No statistical analyses for this end point

Secondary: IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012)

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End point title

IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012) ^[47]

End point description

Concentrations of IgG for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined using the multiplex Luminex immunoassay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. Assay result below LLOQ was set to 0.5*LLOQ. Dose 3 evaluable immunogenicity population: randomized participants aged >=42 to <=84 days in India on day of Dose 1, received the first 3 doses of assigned vaccination, had at least 1 valid immunogenicity result 1 month after Dose 3, had blood collection within 27 to 56 days after Dose 3, had no major protocol deviations. "Number of Participants Analyzed"= participants evaluable for this outcome measure and n= number of participants with valid IgG concentrations for the specified serotype at 1 month after Dose 3.

End point type

Secondary

End point timeframe

1 Month After Dose 3

Notes
[47] - 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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	119	116
Units: Microgram per milliliter
geometric mean (confidence interval 95%)
Serotype 1 (n= 118,116)	1.17 (0.95 to 1.44)	1.61 (1.35 to 1.92)
Serotype 3 (n= 119,116)	0.73 (0.65 to 0.83)	0.97 (0.83 to 1.13)
Serotype 4 (n= 119,116)	1.32 (1.06 to 1.64)	1.60 (1.32 to 1.94)
Serotype 5 (n= 119,116)	0.83 (0.63 to 1.09)	1.16 (0.91 to 1.49)
Serotype 6A (n= 119,116)	1.18 (0.89 to 1.58)	1.73 (1.32 to 2.27)
Serotype 6B (n= 119,114)	0.39 (0.27 to 0.57)	0.61 (0.44 to 0.83)
Serotype 7F (n= 119,116)	1.95 (1.65 to 2.32)	2.20 (1.88 to 2.58)
Serotype 9V (n= 119,116)	1.57 (1.24 to 1.97)	2.06 (1.66 to 2.56)
Serotype 14 (n= 119,116)	1.67 (1.30 to 2.14)	1.76 (1.34 to 2.32)
Serotype 18C (n= 119,116)	1.59 (1.26 to 2.00)	1.79 (1.47 to 2.19)
Serotype 19A (n= 119,116)	1.99 (1.63 to 2.43)	2.26 (1.86 to 2.74)
Serotype 19F (n= 119,116)	2.63 (2.18 to 3.16)	2.96 (2.48 to 3.54)
Serotype 23F (n= 119,116)	1.11 (0.85 to 1.45)	1.60 (1.26 to 2.04)
Serotype 8 (n= 119,116)	2.36 (1.92 to 2.90)	0.04 (0.03 to 0.05)
Serotype 10A (n= 119,116)	0.48 (0.34 to 0.69)	0.03 (0.02 to 0.04)
Serotype 11A (n= 119,116)	3.58 (2.93 to 4.39)	0.04 (0.03 to 0.05)
Serotype 12F (n= 119,116)	0.44 (0.31 to 0.62)	0.01 (0.01 to 0.02)
Serotype 15B (n= 119,116)	6.31 (5.06 to 7.87)	0.05 (0.04 to 0.07)
Serotype 22F (n= 119,116)	4.00 (3.09 to 5.18)	0.01 (0.01 to 0.02)
Serotype 33F (n= 119,116)	1.44 (1.10 to 1.89)	0.06 (0.04 to 0.08)

No statistical analyses for this end point

Secondary: IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants

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End point title

IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants ^[48]

End point description

Concentrations of IgG for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined using the multiplex Luminex immunoassay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs based on the Student's t distribution. Assay result below LLOQ was set to 0.5*LLOQ. Dose 3 evaluable immunogenicity population: randomized participants aged >=56 to <=84 days in Taiwan on day of Dose 1, received the first 3 doses of assigned vaccination, had at least 1 valid immunogenicity result 1 month after Dose 3, had blood collection within 27 to 56 days after Dose 3, had no major protocol deviations. "Number of Participants Analyzed"= participants evaluable for this outcome measure and n= number of participants with valid IgG concentrations for the specified serotype at 1 month after Dose 3.

End point type

Secondary

End point timeframe

1 Month After Dose 3

Notes
[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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	92	94
Units: Microgram per milliliter
geometric mean (confidence interval 95%)
Serotype 1 (n= 92, 94)	2.76 (2.32 to 3.27)	3.00 (2.42 to 3.72)
Serotype 3 (n= 92, 94)	1.05 (0.92 to 1.21)	1.22 (1.04 to 1.42)
Serotype 4 (n= 92, 94)	3.90 (3.27 to 4.64)	3.92 (3.16 to 4.87)
Serotype 5 (n= 92, 94)	3.37 (2.82 to 4.01)	3.49 (2.80 to 4.35)
Serotype 6A (n= 92, 94)	5.28 (4.42 to 6.31)	6.13 (5.08 to 7.40)
Serotype 6B (n= 91, 94)	1.85 (1.50 to 2.28)	2.53 (2.06 to 3.09)
Serotype 7F (n= 92, 94)	4.26 (3.65 to 4.98)	4.90 (4.05 to 5.93)
Serotype 9V (n= 92, 94)	3.17 (2.67 to 3.75)	3.69 (3.01 to 4.52)
Serotype 14 (n= 92, 94)	6.56 (5.56 to 7.74)	5.59 (4.30 to 7.25)
Serotype 18C (n= 92, 94)	3.94 (3.44 to 4.51)	4.04 (3.26 to 5.01)
Serotype 19A (n= 92, 94)	1.74 (1.50 to 2.03)	2.21 (1.85 to 2.64)
Serotype 19F (n= 92, 94)	4.40 (3.80 to 5.10)	5.61 (4.78 to 6.59)
Serotype 23F (n= 92, 94)	2.93 (2.44 to 3.52)	3.71 (3.05 to 4.53)
Serotype 8 (n= 92, 86)	4.61 (4.03 to 5.28)	0.02 (0.02 to 0.03)
Serotype 10A (n= 92, 94)	3.27 (2.60 to 4.11)	0.01 (0.01 to 0.01)
Serotype 11A (n= 92, 94)	5.28 (4.50 to 6.18)	0.01 (0.01 to 0.01)
Serotype 12F (n= 92, 94)	2.05 (1.72 to 2.43)	0.01 (0.01 to 0.01)
Serotype 15B (n= 92, 94)	14.76 (12.49 to 17.44)	0.02 (0.02 to 0.03)
Serotype 22F (n= 92, 94)	14.55 (12.42 to 17.04)	0.00 (0.00 to 0.01)
Serotype 33F (n= 92, 94)	4.04 (3.18 to 5.14)	0.02 (0.02 to 0.02)

No statistical analyses for this end point

Secondary: Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012) ^[49]

End point description

Percentage of participants with predefined serotype-specific IgG concentrations (serotype 5: >=0.23 microgram per milliliter [mcg/mL]: serotype 6B: >=0.10 mcg/mL: serotype 19A: >=0.12 mcg/mL and serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F: >=0.35 mcg/mL) is reported in this outcome measure. Dose 3 evaluable immunogenicity population: randomized participants aged >=42 to <=84 days in India on day of Dose 1, received the first 3 doses of assigned vaccination, had at least 1 valid immunogenicity result 1 month after Dose 3, had blood collection within 27 to 56 days after Dose 3, had no major protocol deviations. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and n = number of participants with valid assay for the specified serotype.

End point type

Secondary

End point timeframe

1 Month After Dose 3

Notes
[49] - 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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	119	116
Units: Percentage of participants
number (confidence interval 95%)
Serotype 1 (n=118,116)	88.1 (80.9 to 93.4)	94.8 (89.1 to 98.1)
Serotype 3 (n=119,116)	84.9 (77.2 to 90.8)	87.1 (79.6 to 92.6)
Serotype 4 (n=119,116)	89.1 (82.0 to 94.1)	92.2 (85.8 to 96.4)
Serotype 5 (n=119,116)	82.4 (74.3 to 88.7)	88.8 (81.6 to 93.9)
Serotype 6A (n=119,116)	78.2 (69.6 to 85.2)	87.1 (79.6 to 92.6)
Serotype 6B (n=119,114)	76.5 (67.8 to 83.8)	85.1 (77.2 to 91.1)
Serotype 7F (n=119, 116)	96.6 (91.6 to 99.1)	97.4 (92.6 to 99.5)
Serotype 9V (n=119,116)	89.9 (83.0 to 94.7)	88.8 (81.6 to 93.9)
Serotype 14 (n=119,116)	86.6 (79.1 to 92.1)	87.9 (80.6 to 93.2)
Serotype 18C (n=119,116)	87.4 (80.1 to 92.8)	88.8 (81.6 to 93.9)
Serotype 19A (119,116)	98.3 (94.1 to 99.8)	100.0 (96.9 to 100.0)
Serotype 19F (119,116)	96.6 (91.6 to 99.1)	95.7 (90.2 to 98.6)
Serotype 23F (n=119,116)	84.0 (76.2 to 90.1)	88.8 (81.6 to 93.9)
Serotype 8 (n=119,116)	95.8 (90.5 to 98.6)	9.5 (4.8 to 16.3)
Serotype 10A (n=119,116)	57.1 (47.7 to 66.2)	8.6 (4.2 to 15.3)
Serotype 11A (n=119,116)	97.5 (92.8 to 99.5)	8.6 (4.2 to 15.3)
Serotype 12F (n=1119,116)	59.7 (50.3 to 68.6)	6.0 (2.5 to 12.0)
Serotype 15B (n=119,116)	97.5 (92.8 to 99.5)	9.5 (4.8 to 16.3)
Serotype 22F (119,116)	95.0 (89.3 to 98.1)	6.9 (3.0 to 13.1)
Serotype 33F (n=119,116)	86.6 (79.1 to 92.1)	11.2 (6.1 to 18.4)

No statistical analyses for this end point

Secondary: Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants

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End point title

Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants ^[50]

End point description

Percentage of participants with predefined serotype-specific IgG concentrations (serotype 5: >=0.23 microgram per milliliter [mcg/mL]: serotype 6B: >=0.10 mcg/mL: serotype 19A: >=0.12 mcg/mL and serotypes1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F: >=0.35 mcg/mL) is reported in this outcome measure. Dose 3 evaluable immunogenicity population: randomized participants aged >=56 to <=84 days in Taiwan on day of Dose 1, received the first 3 doses of assigned vaccination, had at least 1 valid immunogenicity result 1 month after Dose 3, had blood collection within 27 to 56 days after Dose 3, had no major protocol deviations. "Number of Participants Analyzed (N)"= participants evaluable for this outcome measure and n = number of participants with valid assay for the specified serotype.

End point type

Secondary

End point timeframe

1 Month After Dose 3

Notes
[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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	92	94
Units: Percentage of participants
number (confidence interval 95%)
Serotype 1 (n=92,94)	100.0 (96.1 to 100.0)	98.9 (94.2 to 100.0)
Serotype 3 (n=92,94)	97.8 (92.4 to 99.7)	96.8 (91.0 to 99.3)
Serotype 4 (n=92,94)	100.0 (96.1 to 100.0)	96.8 (91.0 to 99.3)
Serotype 5 (n=92,94)	100.0 (96.1 to 100.0)	98.9 (94.2 to 100.0)
Serotype 6A (n=92,94)	98.9 (94.1 to 100.0)	98.9 (94.2 to 100.0)
Serotype 6B (n=91,94)	100.0 (96.0 to 100.0)	98.9 (94.2 to 100.0)
Serotype 7F (n=92,94)	100.0 (96.1 to 100.0)	98.9 (94.2 to 100.0)
Serotype 9V (n=92,94)	98.9 (94.1 to 100.0)	98.9 (94.2 to 100.0)
Serotype 14 (n=92,94)	98.9 (94.1 to 100.0)	94.7 (88.0 to 98.3)
Serotype 18C (n=92,94)	100.0 (96.1 to 100.0)	98.9 (94.2 to 100.0)
Serotype 19A (n=92,94)	100.0 (96.1 to 100.0)	100.0 (96.2 to 100.0)
Serotype 19F (n=92,94)	100.0 (96.1 to 100.0)	100.0 (96.2 to 100.0)
Serotype 23F (n=92,94)	100.0 (96.1 to 100.0)	98.9 (94.2 to 100.0)
Serotype 8 (n=92,86)	100.0 (96.1 to 100.0)	0 (0.0 to 4.2)
Serotype 10A (n=92,94)	96.7 (90.8 to 99.3)	0.0 (0.0 to 3.8)
Serotype 11A (n=92,94)	100.0 (96.1 to 100.0)	0.0 (0.0 to 3.8)
Serotype 12F (n=92,94)	97.8 (92.4 to 99.7)	0.0 (0.0 to 3.8)
Serotype 15B (n=92,94)	100.0 (96.1 to 100.0)	1.1 (0.0 to 5.8)
Serotype 22F (n=92,94)	100.0 (96.1 to 100.0)	0.0 (0.0 to 3.8)
Serotype 33F (n=92,94)	97.8 (92.4 to 99.7)	0.0 (0.0 to 3.8)

No statistical analyses for this end point

Secondary: IgG GMC for the 20vPnC Serotypes at 1 Month After Dose 4- Taiwan Participants only

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End point title

IgG GMC for the 20vPnC Serotypes at 1 Month After Dose 4- Taiwan Participants only ^[51]

End point description

Concentrations of IgG for the 20 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, and 33F) were determined using the multiplex Luminex immunoassay. GMCs and 2-sided CIs were calculated by exponentiating the mean logarithm of the concentrations and corresponding CIs based on Student's t distribution. Assay result below LLOQ was set to 0.5*LLOQ. Dose 4 evaluable immunogenicity population: eligible participants with specified age on day of Dose 1 and who received all 4 randomized vaccinations with Dose 4 received within 365-455 days of age, had at least 1 valid immunogenicity result after Dose 4, had blood collection within 27 to 56 days after Dose 4, had no other major protocol deviations as determined by the clinician. N= participants evaluable for this outcome measure. n= number of participants with valid IgG concentrations for the specified serotype reported at 1 month after Dose 4.

End point type

Secondary

End point timeframe

1 Month After Dose 4

Notes
[51] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	88	92
Units: Microgram per milliliter
geometric mean (confidence interval 95%)
Serotype 1 (n=88,92)	4.10 (3.41 to 4.94)	4.60 (3.74 to 5.67)
Serotype 3 (n=88,92)	1.56 (1.28 to 1.90)	1.71 (1.43 to 2.05)
Serotype 4 (n=88,92)	7.83 (6.41 to 9.57)	8.13 (6.69 to 9.88)
Serotype 5 (n=88,92)	5.48 (4.50 to 6.68)	5.69 (4.62 to 7.01)
Serotype 6A (n=88,92)	14.72 (12.13 to 17.87)	15.34 (12.52 to 18.80)
Serotype 6B (n=88,92)	7.10 (5.78 to 8.71)	8.63 (6.79 to 10.96)
Serotype 7F (n=88,92)	8.08 (6.74 to 9.67)	9.51 (7.82 to 11.56)
Serotype 9V (n=88,92)	6.61 (5.47 to 8.00)	7.98 (6.53 to 9.75)
Serotype 14 (n=88,92)	11.39 (9.53 to 13.61)	9.82 (8.21 to 11.75)
Serotype 18C (n=88,92)	9.07 (7.48 to 10.99)	9.83 (7.93 to 12.18)
Serotype 19A (n=88,92)	5.60 (4.55 to 6.90)	6.62 (5.53 to 7.91)
Serotype 19F (n=88,92)	8.12 (6.60 to 9.99)	10.23 (8.52 to 12.27)
Serotype 23F (n=88,92)	10.35 (8.22 to 13.04)	12.49 (9.94 to 15.69)
Serotype 8 (n=88,85)	8.29 (6.88 to 9.99)	0.04 (0.03 to 0.05)
Serotype 10A (n=88,92)	13.75 (11.21 to 16.86)	0.01 (0.01 to 0.02)
Serotype 11A (n=88,92)	7.25 (6.00 to 8.77)	0.01 (0.01 to 0.01)
Serotype 12F (n=88,92)	3.96 (3.19 to 4.92)	0.01 (0.01 to 0.01)
Serotype 15B (n=88,92)	23.35 (19.33 to 28.20)	0.03 (0.02 to 0.03)
Serotype 22F (n=88,92)	26.05 (21.22 to 31.98)	0.01 (0.00 to 0.01)
Serotype 33F (n=88,92)	14.95 (12.22 to 18.30)	0.01 (0.01 to 0.01)

No statistical analyses for this end point

Secondary: Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- India Participants (Excluding Site 1012)

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End point title

Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- India Participants (Excluding Site 1012) ^[52]

End point description

Percentage of participants with predefined serotype-specific IgG concentrations (serotype 5: >=0.23 microgram per milliliter [mcg/mL]: serotype 6B: >=0.10 mcg/mL: serotype 19A: >=0.12 mcg/mL and serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F: >=0.35 mcg/mL) is reported in this outcome measure. Dose 4 evaluable immunogenicity population: eligible participants with specified age on day of Dose 1 and who received all 4 randomized vaccinations with Dose 4 received within 365-455 days of age, had at least 1 valid immunogenicity result after Dose 4, had blood collection within 27 to 56 days after Dose 4, had no other major protocol deviations as determined by the clinician. N= participants evaluable for this outcome measure and n= number of participants with valid assay results for the specified serotype.

End point type

Secondary

End point timeframe

1 Month after Dose 4

Notes
[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 summarized for specified reporting arms only.

End point values	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)
Number of subjects analysed	112	104
Units: Percentage of Participants
number (confidence interval 95%)
Serotype 1 (n=112, 104)	98.2 (93.7 to 99.8)	100.0 (96.5 to 100.0)
Serotype 3 (n=112, 104)	90.2 (83.1 to 95.0)	100.0 (96.5 to 100.0)
Serotype 4 (n=112, 104)	100.0 (96.8 to 100.0)	100.0 (96.5 to 100.0)
Serotype 5 (n=112, 104)	98.2 (93.7 to 99.8)	100.0 (96.5 to 100.0)
Serotype 6A (n=112, 104)	99.1 (95.1 to 100.0)	100.0 (96.5 to 100.0)
Serotype 6B (n=112, 104)	100.0 (96.8 to 100.0)	100.0 (96.5 to 100.0)
Serotype 7F (n=112, 104)	100.0 (96.8 to 100.0)	100.0 (96.5 to 100.0)
Serotype 9V (n=112, 104)	96.4 (91.1 to 99.0)	99.0 (94.8 to 100.0)
Serotype 14 (n=112, 104)	97.3 (92.4 to 99.4)	98.1 (93.2 to 99.8)
Serotype 18C (n=112, 104)	98.2 (93.7 to 99.8)	100.0 (96.5 to 100.0)
Serotype 19A (n=112, 104)	99.1 (95.1 to 100.0)	100.0 (96.5 to 100.0)
Serotype 19F (n=111, 104)	98.2 (93.6 to 99.8)	99.0 (94.8 to 100.0)
Serotype 23F (n=112, 104)	96.4 (91.1 to 99.0)	97.1 (91.8 to 99.4)
Serotype 8 (n=112, 104)	94.6 (88.7 to 98.0)	29.8 (21.2 to 39.6)
Serotype 10A (n=112, 104)	97.3 (92.4 to 99.4)	10.6 (5.4 to 18.1)
Serotype 11A (n=112, 104)	96.4 (91.1 to 99.0)	19.2 (12.2 to 28.1)
Serotype 12F (n=112, 104)	97.3 (92.4 to 99.4)	9.6 (4.7 to 17.0)
Serotype 15B (n=112, 104)	92.9 (86.4 to 96.9)	10.6 (5.4 to 18.1)
Serotype 22F (n=112, 104)	92.0 (85.3 to 96.3)	14.4 (8.3 to 22.7)
Serotype 33F (n=112, 104)	98.2 (93.7 to 99.8)	18.3 (11.4 to 27.1)

No statistical analyses for this end point

Secondary: Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- Taiwan Participants

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End point title

Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- Taiwan Participants ^[53]

End point description

Percentage of participants with predefined serotype-specific IgG concentrations (serotype 5: >=0.23 microgram per milliliter [mcg/mL]: serotype 6B: >=0.10 mcg/mL: serotype 19A: >=0.12 mcg/mL and serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F: >=0.35 mcg/mL) is reported in this outcome measure. Dose 4 evaluable immunogenicity population: eligible participants with specified age on day of Dose 1 and who received all 4 randomized vaccinations with Dose 4 received within 365-455 days of age, had at least 1 valid immunogenicity result after Dose 4, had blood collection within 27 to 56 days after Dose 4, had no other major protocol deviations as determined by the clinician. N= participants evaluable for this outcome measure and n= number of participants with valid assay for the specified serotype.

End point type

Secondary

End point timeframe

1 Month after Dose 4

Notes
[53] - 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 summarized for specified reporting arms only.

End point values	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Number of subjects analysed	88	92
Units: Percentage of Participants
number (confidence interval 95%)
Serotype 1 (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 3 (n=88,92)	95.5 (88.8 to 98.7)	97.8 (92.4 to 99.7)
Serotype 4 (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 5 (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 6A (n=88,92)	100.0 (95.9 to 100.0)	98.9 (94.1 to 100.0)
Serotype 6B (n=88,92)	100.0 (95.9 to 100.0)	98.9 (94.1 to 100.0)
Serotype 7F (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 9V (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 14 (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 18C (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 19A (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 19F (n=88,92)	100.0 (95.9 to 100.0)	100.0 (96.1 to 100.0)
Serotype 23F (n=88,92)	100.0 (95.9 to 100.0)	98.9 (94.1 to 100.0)
Serotype 8 (n=88,85)	100.0 (95.9 to 100.0)	4.7 (1.3 to 11.6)
Serotype 10A (n=88,92)	100.0 (95.9 to 100.0)	1.1 (0.0 to 5.9)
Serotype 11A (n=88,92)	100.0 (95.9 to 100.0)	1.1 (0.0 to 5.9)
Serotype 12F (n=88,92)	100.0 (95.9 to 100.0)	0 (0.0 to 3.9)
Serotype 15B (n=88,92)	100.0 (95.9 to 100.0)	3.3 (0.7 to 9.2)
Serotype 22F (n=88,92)	100.0 (95.9 to 100.0)	1.1 (0.0 to 5.9)
Serotype 33F (n=88,92)	100.0 (95.9 to 100.0)	1.1 (0.0 to 5.9)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Local reactions and systemic events (systematic assessment): From Day 1 through Day 7 after each dose; non-systematic assessment (SAEs: from Dose (D)1 up to 1 month after D4; other AEs: from D1 up to 1 month after D3 and from D4 up to 1 month after D4)

Adverse event reporting additional description

Same events may appear as both an SAE and a non-SAE. However, what are presented are distinct events. An event may be classified as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a SAE and non-SAE during the study. Safety population was used.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

28.1

Reporting group title

India participants: 20vPnC (Excluding Site 1012)

Reporting group description

Infants from India (Excluding Site 1012) aged 42 to 84 days at the time of enrolment were randomized to receive 4 doses of 0.5 5 mL of 20vPnC intramuscularly. Participants were administered infant doses (dose 1 to dose 3) at approximately 6, 10 and 14 weeks of age. Toddler dose (dose 4) was given at approximately 12 to 15 months of age.

Reporting group title

India participants: 13vPnC (Excluding Site 1012)

Reporting group description

Reporting group title

Taiwan participants: 20vPnC

Reporting group description

Reporting group title

Taiwan participants: 13vPnC

Reporting group description

Serious adverse events	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 125 (0.00%)	2 / 125 (1.60%)	18 / 94 (19.15%)	12 / 96 (12.50%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Congenital, familial and genetic disorders
Enteric duplication
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Scalp haematoma
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Enterocolitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Diarrhoea infectious
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	1 / 125 (0.80%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia viral
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	1 / 125 (0.80%)	0 / 94 (0.00%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiolitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	5 / 94 (5.32%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 5	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
COVID-19
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	2 / 94 (2.13%)	2 / 96 (2.08%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Campylobacter gastroenteritis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	3 / 96 (3.13%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Exanthema subitum
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastroenteritis salmonella
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia parainfluenzae viral
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	2 / 94 (2.13%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Influenza
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus bronchiolitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus infection
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Viral infection
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Urinary tract infection
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	3 / 94 (3.19%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	0 / 96 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Systemic viral infection
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	1 / 96 (1.04%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	India participants: 20vPnC (Excluding Site 1012)	India participants: 13vPnC (Excluding Site 1012)	Taiwan participants: 20vPnC	Taiwan participants: 13vPnC
Total subjects affected by non serious adverse events
subjects affected / exposed	123 / 125 (98.40%)	122 / 125 (97.60%)	93 / 94 (98.94%)	95 / 96 (98.96%)
Investigations
SARS-CoV-2 antibody test positive
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	4 / 94 (4.26%)	0 / 96 (0.00%)
occurrences all number	0	0	4	0
SARS-CoV-2 test positive
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	6 / 94 (6.38%)	10 / 96 (10.42%)
occurrences all number	0	0	6	10
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
alternative assessment type: Systematic
subjects affected / exposed	55 / 125 (44.00%)	53 / 125 (42.40%)	73 / 94 (77.66%)	73 / 96 (76.04%)
occurrences all number	55	53	73	73
General disorders and administration site conditions
Injection site pain (PAIN AT INJECTION SITE)
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
alternative assessment type: Systematic
subjects affected / exposed	109 / 125 (87.20%)	107 / 125 (85.60%)	40 / 94 (42.55%)	38 / 96 (39.58%)
occurrences all number	109	107	40	38
Pyrexia (FEVER)
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
alternative assessment type: Systematic
subjects affected / exposed	36 / 125 (28.80%)	32 / 125 (25.60%)	31 / 94 (32.98%)	35 / 96 (36.46%)
occurrences all number	36	32	31	35
Swelling (SWELLING)
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
alternative assessment type: Systematic
subjects affected / exposed	37 / 125 (29.60%)	34 / 125 (27.20%)	47 / 94 (50.00%)	47 / 96 (48.96%)
occurrences all number	37	34	47	47
Gastrointestinal disorders
Diarrhoea
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	4 / 125 (3.20%)	0 / 94 (0.00%)	0 / 96 (0.00%)
occurrences all number	0	4	0	0
Skin and subcutaneous tissue disorders
Erythema (REDNESS)
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
alternative assessment type: Systematic
subjects affected / exposed	20 / 125 (16.00%)	25 / 125 (20.00%)	46 / 94 (48.94%)	43 / 96 (44.79%)
occurrences all number	20	25	46	43
Dermatitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	6 / 94 (6.38%)	6 / 96 (6.25%)
occurrences all number	0	0	7	6
Dermatitis atopic
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	4 / 94 (4.26%)	6 / 96 (6.25%)
occurrences all number	0	0	4	6
Eczema
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	6 / 94 (6.38%)	4 / 96 (4.17%)
occurrences all number	0	0	6	5
Dermatitis diaper
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	2 / 94 (2.13%)	3 / 96 (3.13%)
occurrences all number	0	0	2	3
Dermatitis contact
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	1 / 94 (1.06%)	3 / 96 (3.13%)
occurrences all number	0	0	1	3
Seborrhoeic dermatitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	4 / 96 (4.17%)
occurrences all number	0	0	0	4
Psychiatric disorders
Irritability (IRRITABILITY)
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
alternative assessment type: Systematic
subjects affected / exposed	105 / 125 (84.00%)	106 / 125 (84.80%)	65 / 94 (69.15%)	67 / 96 (69.79%)
occurrences all number	105	106	65	67
Infections and infestations
Upper respiratory tract infection
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	11 / 125 (8.80%)	16 / 125 (12.80%)	6 / 94 (6.38%)	11 / 96 (11.46%)
occurrences all number	12	17	6	12
Viral infection
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	4 / 125 (3.20%)	4 / 125 (3.20%)	0 / 94 (0.00%)	0 / 96 (0.00%)
occurrences all number	4	4	0	0
Bronchiolitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	2 / 94 (2.13%)	3 / 96 (3.13%)
occurrences all number	0	0	2	3
COVID-19
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	8 / 94 (8.51%)	8 / 96 (8.33%)
occurrences all number	0	0	8	8
Otitis media acute
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	0 / 94 (0.00%)	4 / 96 (4.17%)
occurrences all number	0	0	0	4
Nasopharyngitis
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	10 / 94 (10.64%)	15 / 96 (15.63%)
occurrences all number	0	0	11	15
Hand-foot-and-mouth disease
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
subjects affected / exposed	0 / 125 (0.00%)	0 / 125 (0.00%)	3 / 94 (3.19%)	0 / 96 (0.00%)
occurrences all number	0	0	3	0
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
Additional description: MedDRA v 26.1 for Taiwan and MedDRA v 28.1 for India
alternative assessment type: Systematic
subjects affected / exposed	40 / 125 (32.00%)	46 / 125 (36.80%)	58 / 94 (61.70%)	58 / 96 (60.42%)
occurrences all number	40	46	58	58

More information

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Were there any global substantial amendments to the protocol? Yes

06 Nov 2023

Amendment 1: Added a primary immunogenicity objective, outcome measure, and estimand specific to the participants in India after Dose 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 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine Given in A Series of 3 Infant Doses And 1 Toddler Dose in Infants in India and Taiwan

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- Taiwan Participants

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 1- Taiwan Participants

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- Taiwan Participants

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 2- Taiwan Participants

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- Taiwan Participants

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 3- Taiwan Participants

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- Taiwan Participants

Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Dose 4- Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1- Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 2- Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 3- Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4- India Participants (Excluding Site 1012)

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4-Taiwan Participants

Primary: Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 4-Taiwan Participants

Primary: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3- India Participants (Excluding Site 1012)

Primary: Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3- India Participants (Excluding Site 1012)

Primary: Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 3- Taiwan Participants

Primary: Percentage of Participants With AEs From Dose 1 to 1 Month After Dose 3- Taiwan Participants

Primary: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- India Participants (Excluding Site 1012)

Primary: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- India Participants (Excluding Site 1012)

Primary: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- Taiwan Participants

Primary: Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4- Taiwan Participants

Primary: Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 4- Taiwan Participants

Primary: Percentage of Participants With SAEs From Dose 1 to 1 Month After Dose 4- Taiwan Participants

Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4- India Participants (Excluding Site 1012)

Primary: Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4- India Participants (Excluding Site 1012)

Primary: Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) Serotypes at 1 Month After Dose 4- India Participants Only (Excluding Site 1012)

Primary: Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) Serotypes at 1 Month After Dose 4- India Participants Only (Excluding Site 1012)

Secondary: IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012)

Secondary: IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012)

Secondary: IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants

Secondary: IgG GMCs for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants

Secondary: Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012)

Secondary: Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- India Participants (Excluding Site 1012)

Secondary: Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants

Secondary: Percentage of Participants With Predefined Serotype-specific IgG Concentrations for the 20vPnC Serotypes at 1 Month After Dose 3- Taiwan Participants

Secondary: IgG GMC for the 20vPnC Serotypes at 1 Month After Dose 4- Taiwan Participants only

Secondary: IgG GMC for the 20vPnC Serotypes at 1 Month After Dose 4- Taiwan Participants only

Secondary: Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- India Participants (Excluding Site 1012)

Secondary: Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- India Participants (Excluding Site 1012)

Secondary: Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- Taiwan Participants

Secondary: Percentage of Participants with Predefined Serotype-specific IgG Concentration for the 20vPnC Serotypes at 1 Month after Dose 4- Taiwan Participants

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 3, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine Given in A Series of 3 Infant Doses And 1 Toddler Dose in Infants in India and Taiwan