Download PDF

Clinical Trial Results:
A Phase 3, Randomized, Double-blind, Third Party Unblind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

Summary
EudraCT number	2022-001146-38
Trial protocol	Outside EU/EEA
Global end of trial date	02 Apr 2022

Results information
Results version number	v2(current)
This version publication date	21 Jun 2023
First version publication date	16 Oct 2022
Other versions	v1
Version creation reason

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

B7471016

ISRCTN number

US NCT number

NCT04530838

WHO universal trial number (UTN)

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, 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

21 Apr 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

02 Apr 2022

Was the trial ended prematurely?

Main objective of the trial

Safety: To describe the safety profile of 20-valent Pneumococcal Conjugate Vaccine (20vPnC) by both subcutaneous (SC) injection and intramuscular (IM) injection. Immunogenicity: To demonstrate the percentage of subjects with predefined serotype-specific Immunoglobulin G (IgG) concentrations for the 13 serotypes in the 20vPnC SC group are noninferior to the percentage of the corresponding serotypes in the 13vPnC SC group at 1 month after Dose 3. To demonstrate the percentage of subjects with predefined serotype-specific IgG concentrations for the 7 additional serotypes in the 20vPnC SC group are noninferior to the lowest percentage among the 13 serotypes in the 13vPnC SC group at 1 month after Dose 3. To describe the immune responses to 20 serotypes induced by 20vPnC given by IM injection at 1 month after Dose 3.

Protection of trial subjects

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

Background therapy

Evidence for comparator

Actual start date of recruitment

16 Sep 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Japan: 668

Worldwide total number of subjects

668

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)

668

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

A total of 668 subjects were enrolled and randomised in the study. One subject did not receive any study vaccine. One subject receive vaccination through route which was not as per randomisation. Hence, data of these subjects were excluded from analysis.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

20vPnC (SC)

Arm description

Subjects received 4 doses of 0.5 milliliter (mL) 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Subjects completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.

Arm type

Experimental

Investigational medicinal product name

20-Valent Pneumococcal Conjugate Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 0.5 mL dose of 20vPnC subcutaneously on Visits 1, 2, 3, and 5 with Dose 1, 2, 3, and 4, respectively.

13vPnC (SC)

Arm description

Subjects received 4 doses of 0.5 mL 13vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Subjects completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.

Arm type

Experimental

Investigational medicinal product name

13-Valent Pneumococcal Conjugate Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received 0.5 mL dose of 13vPnC subcutaneously on Visits 1, 2, 3, and 5 with Dose 1, 2, 3, and 4, respectively.

20vPnC (IM)

Arm description

Subjects received 4 doses of 0.5 mL 20vPnC IM into the anterolateral thigh muscle. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Subjects completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.

Arm type

Experimental

Investigational medicinal product name

20-Valent Pneumococcal Conjugate Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects received 0.5 mL dose of 20vPnC intramuscularly on Visits 1, 2, 3, and 5 with Dose 1, 2, 3, and 4, respectively.

Number of subjects in period 1 ^[1]	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Started	225	224	217
Completed	217	220	211
Not completed	8	4	6
Physician decision	-	-	1
No longer meets eligibility criteria	1	-	2
Adverse event, non-fatal	-	1	-
Death	-	-	1
Unspecified	2	1	-
Withdrawal by parent/guardian	5	2	2

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: A total of 668 subjects were enrolled and randomized in the study. One subject did not receive any treatment. One subject receive vaccination through route which was not as per randomization. Hence, data of these subjects were excluded from analysis.

Baseline characteristics

Top of page

Reporting group title

20vPnC (SC)

Reporting group description

Reporting group title

13vPnC (SC)

Reporting group description

Reporting group title

20vPnC (IM)

Reporting group description

Reporting group values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)	Total
Number of subjects	225	224	217	666
Age Categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	225	224	217	666
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	0	0	0	0
From 65-84 years	0	0	0	0
85 years and over	0	0	0	0
Age Continuous
Units: months
arithmetic mean (standard deviation)	2.4 ( 0.33 )	2.4 ( 0.40 )	2.4 ( 0.42 )	-
Gender Categorical
Units: Subjects
Female	117	114	106	337
Male	108	110	111	329
Ethnicity
Units: Subjects
Non-Hispanic/non-Latino	225	224	217	666
Race
Units: Subjects
Asian	225	224	217	666

End points

Top of page

Reporting group title

20vPnC (SC)

Reporting group description

Reporting group title

13vPnC (SC)

Reporting group description

Reporting group title

20vPnC (IM)

Reporting group description

Primary: Percentage of Subjects With Local Reactions (LR) Within 7 Days After Dose 1

Top of page

End point title

Percentage of Subjects With Local Reactions (LR) Within 7 Days After Dose 1 ^[1]

End point description

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimetre (cm). Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. Safety population included all the subjects who received at least 1 dose of the investigational product (IP) with safety follow up after Dose 1.

End point type

Primary

End point timeframe

Within 7 Days after Dose 1

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	225	224	217
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Mild	58.2 (51.5 to 64.7)	51.3 (44.6 to 58.1)	26.3 (20.5 to 32.7)
Redness: Moderate	20.0 (15.0 to 25.8)	23.7 (18.3 to 29.8)	11.1 (7.2 to 16.0)
Redness: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Swelling: Mild	48.9 (42.2 to 55.6)	42.9 (36.3 to 49.6)	17.5 (12.7 to 23.2)
Swelling: Moderate	19.6 (14.6 to 25.3)	23.2 (17.9 to 29.3)	11.1 (7.2 to 16.0)
Swelling: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Pain at the injection site: Mild	15.6 (11.1 to 21.0)	13.4 (9.2 to 18.6)	12.4 (8.4 to 17.6)
Pain at the injection site: Moderate	1.8 (0.5 to 4.5)	2.7 (1.0 to 5.7)	3.2 (1.3 to 6.5)
Pain at the injection site: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0.5 (0.0 to 2.5)

No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2

Top of page

End point title

Percentage of Subjects With Local Reactions Within 7 Days After Dose 2 ^[2]

End point description

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after Dose 2. Here, number of subjects analysed = number of subjects with any e-diary data reported after Dose 2.

End point type

Primary

End point timeframe

Within 7 Days after Dose 2

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	223	222	215
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Mild	52.9 (46.1 to 59.6)	53.2 (46.4 to 59.9)	24.7 (19.0 to 31.0)
Redness: Moderate	23.3 (17.9 to 29.4)	31.1 (25.1 to 37.6)	7.0 (4.0 to 11.2)
Redness: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Swelling: Mild	46.2 (39.5 to 53.0)	46.8 (40.1 to 53.6)	18.1 (13.2 to 24.0)
Swelling: Moderate	22.4 (17.1 to 28.5)	26.6 (20.9 to 32.9)	7.9 (4.7 to 12.4)
Swelling: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Pain at the injection site: Mild	13.0 (8.9 to 18.1)	16.7 (12.0 to 22.2)	9.3 (5.8 to 14.0)
Pain at the injection site: Moderate	3.6 (1.6 to 6.9)	0.5 (0.0 to 2.5)	2.3 (0.8 to 5.3)
Pain at the injection site: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 3

Top of page

End point title

Percentage of Subjects With Local Reactions Within 7 Days After Dose 3 ^[3]

End point description

Local reactions included pain at injection site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after Dose 3. Here, number of subjects analysed = number of subjects with any e-diary data reported after Dose 3.

End point type

Primary

End point timeframe

Within 7 Days after Dose 3

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	222	221	215
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Mild	45.0 (38.4 to 51.8)	51.1 (44.3 to 57.9)	23.3 (17.8 to 29.5)
Redness: Moderate	33.8 (27.6 to 40.4)	34.8 (28.6 to 41.5)	8.4 (5.0 to 12.9)
Redness: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Swelling: Mild	38.7 (32.3 to 45.5)	39.8 (33.3 to 46.6)	17.7 (12.8 to 23.4)
Swelling: Moderate	30.2 (24.2 to 36.7)	35.3 (29.0 to 42.0)	9.8 (6.1 to 14.5)
Swelling: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Pain at the inj. site: Mild	10.8 (7.1 to 15.7)	14.5 (10.1 to 19.8)	8.8 (5.4 to 13.5)
Pain at the inj. site: Moderate	3.6 (1.6 to 7.0)	1.4 (0.3 to 3.9)	0.9 (0.1 to 3.3)
Pain at the inj. site: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.7)	0.5 (0.0 to 2.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 4

Top of page

End point title

Percentage of Subjects With Local Reactions Within 7 Days After Dose 4 ^[4]

End point description

Local reactions included pain at inj. site, redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Pain at injection site was graded as mild: hurts if gently touched; moderate: hurts if gently touched with crying; severe: limited limb movement. Redness and swelling were graded as mild: >0 to 2.0 cm; moderate >2.0 to 7.0 cm; and severe: >7.0 cm. Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after Dose 4. Here, number of subjects analysed = number of subjects with any e-diary data reported after Dose 4.

End point type

Primary

End point timeframe

Within 7 Days after Dose 4

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	218	220	212
Units: Percentage of subjects
number (confidence interval 95%)
Redness: Mild	37.2 (30.7 to 43.9)	36.4 (30.0 to 43.1)	20.8 (15.5 to 26.8)
Redness: Moderate	49.1 (42.3 to 55.9)	49.1 (42.3 to 55.9)	11.8 (7.8 to 16.9)
Redness: Severe	0.5 (0.0 to 2.5)	0.5 (0.0 to 2.5)	0 (0.0 to 1.7)
Swelling: Mild	37.6 (31.2 to 44.4)	35.9 (29.6 to 42.6)	13.2 (9.0 to 18.5)
Swelling: Moderate	42.2 (35.6 to 49.1)	41.8 (35.2 to 48.6)	10.8 (7.0 to 15.8)
Swelling: Severe	0.5 (0.0 to 2.5)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Pain at the inj. site: Mild	19.7 (14.7 to 25.6)	19.1 (14.1 to 24.9)	10.4 (6.6 to 15.3)
Pain at the inj. site: Moderate	1.4 (0.3 to 4.0)	3.2 (1.3 to 6.4)	3.3 (1.3 to 6.7)
Pain at the inj. site: Severe	0 (0.0 to 1.7)	0 (0.0 to 1.7)	0 (0.0 to 1.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events (SE) Within 7 Days After Dose 1

Top of page

End point title

Percentage of Subjects With Systemic Events (SE) Within 7 Days After Dose 1 ^[5]

End point description

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature greater than or equal to (>=) 37.5 degrees Celsius (C), and categorised as >=37.5 to 38.4 degrees C, greater than (>)38.4 to 38.9 degrees C,>38.9 to 40.0 degrees C and >40.0 degrees C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after Dose 1.

End point type

Primary

End point timeframe

Within 7 Days After Dose 1

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: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	225	224	217
Units: Percentage of subjects
number (confidence interval 95%)
Fever: >=37.5 degrees C	9.8 (6.2 to 14.4)	12.9 (8.8 to 18.1)	9.7 (6.1 to 14.4)
Fever: >=37.5°C to 38.4 degrees C	9.3 (5.9 to 13.9)	12.5 (8.5 to 17.6)	9.7 (6.1 to 14.4)
Fever: >38.4°C to 38.9 degrees C	0.4 (0.0 to 2.5)	0.4 (0.0 to 2.5)	0 (0.0 to 1.7)
Fever: >38.9 to 40.0 degree C	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Fever: >40.0 degrees C	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Decreased appetite: Mild	3.6 (1.5 to 6.9)	7.1 (4.1 to 11.3)	3.2 (1.3 to 6.5)
Decreased appetite: Moderate	1.8 (0.5 to 4.5)	3.1 (1.3 to 6.3)	3.2 (1.3 to 6.5)
Decreased appetite: Severe	0 (0.0 to 1.6)	0.4 (0.0 to 2.5)	0 (0.0 to 1.7)
Drowsiness: Mild	40.4 (34.0 to 47.2)	42.0 (35.4 to 48.7)	42.9 (36.2 to 49.7)
Drowsiness: Moderate	0.9 (0.1 to 3.2)	2.2 (0.7 to 5.1)	4.1 (1.9 to 7.7)
Drowsiness: Severe	0 (0.0 to 1.6)	0.4 (0.0 to 2.5)	0 (0.0 to 1.7)
Irritability: Mild	13.8 (9.6 to 19.0)	11.2 (7.4 to 16.0)	12.9 (8.7 to 18.1)
Irritability: Moderate	12.0 (8.1 to 17.0)	13.4 (9.2 to 18.6)	11.5 (7.6 to 16.5)
Irritability: Severe	1.3 (0.3 to 3.8)	1.8 (0.5 to 4.5)	0.5 (0.0 to 2.5)

No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2

Top of page

End point title

Percentage of Subjects With Systemic Events Within 7 Days After Dose 2 ^[6]

End point description

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degrees C and categorised as >=37.5 to 38.4 degrees C,>38.4 to 38.9 degrees C,>38.9 to 40.0 degrees C and >40.0 degrees C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after Dose 2. Here, number of subjects analysed = number of subjects with any e-diary data reported after Dose 2.

End point type

Primary

End point timeframe

Within 7 Days After Dose 2

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	223	222	215
Units: Percentage of subjects
number (confidence interval 95%)
Fever: >=37.5 degrees C	20.2 (15.1 to 26.1)	21.2 (16.0 to 27.1)	18.1 (13.2 to 24.0)
Fever: >=37.5 to 38.4 degrees C	15.2 (10.8 to 20.6)	17.6 (12.8 to 23.2)	14.9 (10.4 to 20.4)
Fever: >38.4 to 38.9 degrees C	3.1 (1.3 to 6.4)	2.3 (0.7 to 5.2)	1.9 (0.5 to 4.7)
Fever: >38.9 to 40.0 degrees C	1.8 (0.5 to 4.5)	1.4 (0.3 to 3.9)	1.4 (0.3 to 4.0)
Fever: >40.0 degrees C	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Decreased appetite: Mild	4.5 (2.2 to 8.1)	6.8 (3.8 to 10.9)	5.1 (2.6 to 9.0)
Decreased appetite: Moderate	5.8 (3.1 to 9.8)	5.0 (2.5 to 8.7)	4.7 (2.3 to 8.4)
Decreased appetite: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Drowsiness: Mild	39.9 (33.4 to 46.7)	48.6 (41.9 to 55.4)	39.5 (33.0 to 46.4)
Drowsiness: Moderate	3.1 (1.3 to 6.4)	4.1 (1.9 to 7.6)	2.3 (0.8 to 5.3)
Drowsiness: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.6)	0 (0.0 to 1.7)
Irritability: Mild	12.6 (8.5 to 17.6)	16.7 (12.0 to 22.2)	10.2 (6.5 to 15.1)
Irritability: Moderate	12.1 (8.1 to 17.1)	14.9 (10.5 to 20.2)	15.3 (10.8 to 20.9)
Irritability: Severe	1.3 (0.3 to 3.9)	0.5 (0.0 to 2.5)	1.4 (0.3 to 4.0)

No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 3

Top of page

End point title

Percentage of Subjects With Systemic Events Within 7 Days After Dose 3 ^[7]

End point description

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degrees C and categorised as >=37.5 to 38.4 degrees C,>38.4 to 38.9 degrees C,>38.9 to 40.0 degrees C and >40.0 degrees C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after Dose 3. Here, number of subjects analysed = number of subjects with any e-diary data reported after Dose 3.

End point type

Primary

End point timeframe

Within 7 Days After Dose 3

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: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	222	221	215
Units: Percentage of subjects
number (confidence interval 95%)
Fever: >=37.5 degrees C	15.3 (10.8 to 20.7)	19.9 (14.9 to 25.8)	15.3 (10.8 to 20.9)
Fever: >=37.5 to 38.4 degrees C	13.5 (9.3 to 18.7)	16.3 (11.7 to 21.8)	12.6 (8.4 to 17.7)
Fever: >38.4 to 38.9 degrees C	1.4 (0.3 to 3.9)	2.7 (1.0 to 5.8)	1.9 (0.5 to 4.7)
Fever: >38.9 to 40.0 degrees C	0.5 (0.0 to 2.5)	0.9 (0.1 to 3.2)	0.9 (0.1 to 3.3)
Fever: >40.0 degrees C	0 (0.0 to 1.6)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Decreased appetite: Mild	5.0 (2.5 to 8.7)	7.2 (4.2 to 11.5)	4.2 (1.9 to 7.8)
Decreased appetite: Moderate	2.7 (1.0 to 5.8)	3.6 (1.6 to 7.0)	3.7 (1.6 to 7.2)
Decreased appetite: Severe	0.5 (0.0 to 2.5)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Drowsiness: Mild	24.8 (19.2 to 31.0)	32.6 (26.4 to 39.2)	32.6 (26.3 to 39.3)
Drowsiness: Moderate	1.4 (0.3 to 3.9)	1.8 (0.5 to 4.6)	1.4 (0.3 to 4.0)
Drowsiness: Severe	0 (0.0 to 1.6)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Irritability: Mild	16.7 (12.0 to 22.2)	10.9 (7.1 to 15.7)	14.0 (9.6 to 19.3)
Irritability: Moderate	8.6 (5.2 to 13.0)	9.0 (5.6 to 13.6)	13.0 (8.8 to 18.3)
Irritability: Severe	0.5 (0.0 to 2.5)	0 (0.0 to 1.7)	0.9 (0.1 to 3.3)

No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 4

Top of page

End point title

Percentage of Subjects With Systemic Events Within 7 Days After Dose 4 ^[8]

End point description

Systemic events included fever, decreased appetite, drowsiness and irritability. Fever was defined as an axillary temperature >=37.5 degrees C and categorised as >=37.5 to 38.4 degrees C,>38.4 to 38.9 degrees C,>38.9 to 40.0 degrees C and >40.0 degrees C; decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed); drowsiness 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: graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after Dose 4. Here, number of subjects analysed = number of subjects with any e-diary data reported after Dose 4.

End point type

Primary

End point timeframe

Within 7 Days After Dose 4

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	218	220	212
Units: Percentage of subjects
number (confidence interval 95%)
Fever: >=37.5 degrees C	42.7 (36.0 to 49.5)	39.5 (33.0 to 46.3)	38.2 (31.6 to 45.1)
Fever: >=37.5 to 38.4 degrees C	25.7 (20.0 to 32.0)	29.1 (23.2 to 35.6)	24.1 (18.5 to 30.4)
Fever: >38.4 to 38.9 degrees C	10.1 (6.4 to 14.9)	5.9 (3.2 to 9.9)	6.1 (3.3 to 10.3)
Fever: >38.9 to 40.0 degrees C	6.4 (3.6 to 10.5)	4.5 (2.2 to 8.2)	8.0 (4.7 to 12.5)
Fever: >40.0 degrees C	0.5 (0.0 to 2.5)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Decreased appetite: Mild	6.4 (3.6 to 10.5)	6.8 (3.9 to 11.0)	6.1 (3.3 to 10.3)
Decreased appetite: Moderate	7.3 (4.3 to 11.6)	7.7 (4.6 to 12.1)	5.7 (3.0 to 9.7)
Decreased appetite: Severe	0 (0.0 to 1.7)	0 (0.0 to 1.7)	0.9 (0.1 to 3.4)
Drowsiness: Mild	24.3 (18.8 to 30.6)	23.6 (18.2 to 29.8)	29.7 (23.7 to 36.4)
Drowsiness: Moderate	1.4 (0.3 to 4.0)	2.3 (0.7 to 5.2)	1.9 (0.5 to 4.8)
Drowsiness: Severe	0 (0.0 to 1.7)	0 (0.0 to 1.7)	0 (0.0 to 1.7)
Irritability: Mild	14.2 (9.9 to 19.6)	15.5 (10.9 to 20.9)	15.1 (10.6 to 20.6)
Irritability: Moderate	7.3 (4.3 to 11.6)	11.4 (7.5 to 16.3)	9.4 (5.9 to 14.2)
Irritability: Severe	0.9 (0.1 to 3.3)	0.9 (0.1 to 3.2)	0.5 (0.0 to 2.6)

No statistical analyses for this end point

Primary: Percentage of Subjects With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3

Top of page

End point title

Percentage of Subjects With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 ^[9]

End point description

An adverse event (AE) was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Safety population included all the subjects who received at least 1 dose of the IP and had safety data after any dose.

End point type

Primary

End point timeframe

Day 1 of Dose 1 to 1 Month after Dose 3

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	225	224	217
Units: Percentage of subjects
number (confidence interval 95%)	47.6 (40.9 to 54.3)	55.4 (48.6 to 62.0)	58.5 (51.7 to 65.2)

No statistical analyses for this end point

Primary: Percentage of Subjects With AEs from Dose 4 to 1 Month After Dose 4

Top of page

End point title

Percentage of Subjects With AEs from Dose 4 to 1 Month After Dose 4 ^[10]

End point description

An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Safety population included all subjects who received at least 1 dose of the IP with safety follow up after any dose. Here, number of subjects analysed = number of subjects who received Dose 4.

End point type

Primary

End point timeframe

From Dose 4 to 1 Month after Dose 4

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	218	220	212
Units: Percentage of subjects
number (confidence interval 95%)	40.4 (33.8 to 47.2)	43.2 (36.5 to 50.0)	43.9 (37.1 to 50.8)

No statistical analyses for this end point

Primary: Percentage of Subjects With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4

Top of page

End point title

Percentage of Subjects With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4 ^[11]

End point description

A serious AE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect and other important medical events. Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after any dose.

End point type

Primary

End point timeframe

From Dose 1 to 1 Month after Dose 4

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: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	225	224	217
Units: Percentage of subjects
number (confidence interval 95%)	6.2 (3.4 to 10.2)	4.0 (1.9 to 7.5)	7.4 (4.3 to 11.7)

No statistical analyses for this end point

Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4

Top of page

End point title

Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4 ^[12]

End point description

An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects. Safety population included all the subjects who received at least 1 dose of the IP with safety follow up after any dose. Here, number of subjects analysed=subjects evaluable for this endpoint.

End point type

Primary

End point timeframe

From Dose 1 to 1 Month after Dose 4

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only descriptive data was planned to be analysed for this endpoint.

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	225	224	217
Units: Percentage of subjects
number (confidence interval 95%)	10.7 (7.0 to 15.5)	8.9 (5.5 to 13.5)	8.3 (5.0 to 12.8)

No statistical analyses for this end point

Primary: Percentage of Subjects With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3

Top of page

End point title

Percentage of Subjects With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3

End point description

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. The predefined levels, >=0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL). Dose 3 evaluable immunogenicity population included eligible subjects who were 2 to 6 months of age at the first vaccination, received the first 3 doses as randomised, had at least 1 valid immunogenicity results from blood collection within 27 to 56 days after Dose 3, and had no other major protocol deviations per clinician. Here, number of subjects analysed=subjects with an IgG concentration greater than or equal to(>=)predefined level for given serotype and ‘n’=subjects with valid assay results for the specified serotype.

End point type

Primary

End point timeframe

1 Month after Dose 3

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	221	220	213
Units: Percentage of subjects
number (confidence interval 95%)
Serotype: 1 (n=221, 220, 213)	97.7 (94.8 to 99.3)	99.1 (96.8 to 99.9)	92.0 (87.5 to 95.3)
Serotype: 3 (n=221, 220, 213)	96.4 (93.0 to 98.4)	99.1 (96.8 to 99.9)	95.3 (91.5 to 97.7)
Serotype: 4 (n=221, 220, 213)	96.8 (93.6 to 98.7)	99.1 (96.8 to 99.9)	94.8 (90.9 to 97.4)
Serotype: 5 (n=221, 220, 213)	92.3 (88.0 to 95.5)	97.3 (94.2 to 99.0)	93.0 (88.7 to 96.0)
Serotype: 6A (n=221, 220, 213)	90.0 (85.3 to 93.7)	98.2 (95.4 to 99.5)	94.8 (90.9 to 97.4)
Serotype: 6B (n=221, 220, 213)	87.8 (82.7 to 91.8)	96.4 (93.0 to 98.4)	82.2 (76.3 to 87.1)
Serotype: 7F (n=221, 220, 213)	95.9 (92.4 to 98.1)	99.1 (96.8 to 99.9)	94.8 (90.9 to 97.4)
Serotype: 9V (n=221, 220, 213)	95.9 (92.4 to 98.1)	98.6 (96.1 to 99.7)	93.0 (88.7 to 96.0)
Serotype: 14 (n=220, 220, 213)	96.8 (93.6 to 98.7)	97.7 (94.8 to 99.3)	96.2 (92.7 to 98.4)
Serotype: 18C (n=221, 220, 213)	96.8 (93.6 to 98.7)	99.1 (96.8 to 99.9)	94.8 (90.9 to 97.4)
Serotype: 19A (n=221, 220, 213)	99.5 (97.5 to 100.0)	99.5 (97.5 to 100.0)	99.1 (96.6 to 99.9)
Serotype: 19F (n=221, 220, 213)	100.0 (98.3 to 100.0)	100.0 (98.3 to 100.0)	100.0 (98.3 to 100.0)
Serotype: 23F (n=221, 220, 213)	89.6 (84.8 to 93.3)	93.6 (89.6 to 96.5)	88.7 (83.7 to 92.6)
Serotype: 8 (n=221, 219, 213)	99.5 (97.5 to 100.0)	0.9 (0.1 to 3.3)	99.5 (97.4 to 100.0)
Serotype: 10A (n=221, 220, 213)	60.2 (53.4 to 66.7)	1.8 (0.5 to 4.6)	59.6 (52.7 to 66.3)
Serotype: 11A (n=221, 220, 213)	100.0 (98.3 to 100.0)	2.7 (1.0 to 5.8)	100.0 (98.3 to 100.0)
Serotype: 12F (n=221, 220, 213)	74.7 (68.4 to 80.3)	0.9 (0.1 to 3.2)	74.6 (68.3 to 80.3)
Serotype: 15B (n=221, 220, 213)	99.1 (96.8 to 99.9)	8.2 (4.9 to 12.6)	98.6 (95.9 to 99.7)
Serotype: 22F (n=221, 220, 213)	100.0 (98.3 to 100.0)	0.9 (0.1 to 3.2)	100.0 (98.3 to 100.0)
Serotype: 33F (n=219, 220, 212)	95.0 (91.2 to 97.5)	3.2 (1.3 to 6.4)	92.5 (88.0 to 95.6)

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 1: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[13]

Method

Parameter type

Percentage Difference

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

1.3

Notes
[13] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 5: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[14]

Method

Parameter type

Percentage Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-9.6

upper limit

-0.9

Notes
[14] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 4: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[15]

Method

Parameter type

Percentage Difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-5.6

upper limit

0.5

Notes
[15] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 3: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[16]

Method

Parameter type

Percentage Difference

Point estimate

-2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-6.2

upper limit

0.1

Notes
[16] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 6A: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[17]

Method

Parameter type

Percentage Difference

Point estimate

-8.1

Confidence interval

level

95%

sides

2-sided

lower limit

-13

upper limit

-4

Notes
[17] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 6B: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[18]

Method

Parameter type

Percentage Difference

Point estimate

-8.6

Confidence interval

level

95%

sides

2-sided

lower limit

-14

upper limit

-3.7

Notes
[18] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 7F: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[19]

Method

Parameter type

Percentage Difference

Point estimate

-3.2

Confidence interval

level

95%

sides

2-sided

lower limit

-6.8

upper limit

-0.3

Notes
[19] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 9V: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[20]

Method

Parameter type

Percentage Difference

Point estimate

-2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-6.4

upper limit

0.4

Notes
[20] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 19F: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[21]

Method

Parameter type

Percentage Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

1.7

Notes
[21] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 19A: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[22]

Method

Parameter type

Percentage Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

2.1

Notes
[22] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 23F: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[23]

Method

Parameter type

Percentage Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

1.2

Notes
[23] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 14: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[24]

Method

Parameter type

Percentage Difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

2.4

Notes
[24] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 18C: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[25]

Method

Parameter type

Percentage Difference

Point estimate

-2.3

Confidence interval

level

95%

sides

2-sided

lower limit

-5.6

upper limit

0.5

Notes
[25] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 8: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[26]

Method

Parameter type

Percentage Difference

Point estimate

5.9

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Notes
[26] - For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 10A: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[27]

Method

Parameter type

Percentage Difference

Point estimate

-33.5

Confidence interval

level

95%

sides

2-sided

lower limit

-40.7

upper limit

-26.2

Notes
[27] - For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 11A: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[28]

Method

Parameter type

Percentage Difference

Point estimate

6.4

Confidence interval

level

95%

sides

2-sided

lower limit

3.8

upper limit

10.4

Notes
[28] - For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.

Descriptive comparison

Statistical analysis description

Serotype 3: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-5.2

upper limit

2.9

Descriptive comparison

Statistical analysis description

Serotype 1: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-10.4

upper limit

-1.7

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 33F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[29]

Method

Parameter type

Percentage Difference

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.2

upper limit

Notes
[29] - For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 22F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[30]

Method

Parameter type

Percentage Difference

Point estimate

6.4

Confidence interval

level

95%

sides

2-sided

lower limit

3.8

upper limit

10.4

Notes
[30] - For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 12F: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[31]

Method

Parameter type

Percentage Difference

Point estimate

-19

Confidence interval

level

95%

sides

2-sided

lower limit

-25.7

upper limit

-12.5

Notes
[31] - For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 15B: 2-Sided 95% CIs are calculated using the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[32]

Method

Parameter type

Percentage Difference

Point estimate

5.5

Confidence interval

level

95%

sides

2-sided

lower limit

2.2

upper limit

9.6

Notes
[32] - For the additional 7 serotypes, the compared results are from serotype 23F (13vPnC [SC] serotype with the lowest percentage, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CIs for the percentage differences (20vPnC SC - lowest 13vPnC SC) was greater than -10%.

Descriptive comparison

Statistical analysis description

Serotype 18C: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-6.2

upper limit

1.9

Descriptive comparison

Statistical analysis description

Serotype 19F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

1.7

Descriptive comparison

Statistical analysis description

Serotype 4:2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-6.2

upper limit

1.9

Descriptive comparison

Statistical analysis description

Serotype 5: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.5

upper limit

5.8

Descriptive comparison

Statistical analysis description

Serotype 6A: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

4.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

Descriptive comparison

Statistical analysis description

Serotype 6B: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-5.6

Confidence interval

level

95%

sides

2-sided

lower limit

-12.5

upper limit

1.1

Descriptive comparison

Statistical analysis description

Serotype 7F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-5.4

upper limit

3.1

Descriptive comparison

Statistical analysis description

Serotype 9V: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-7.7

upper limit

1.4

Descriptive comparison

Statistical analysis description

Serotype 19A: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

1.7

Descriptive comparison

Statistical analysis description

Serotype 14: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

3.2

Descriptive comparison

Statistical analysis description

Serotype 33F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-7.5

upper limit

2.2

Descriptive comparison

Statistical analysis description

Serotype 22F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

1.7

Descriptive comparison

Statistical analysis description

Serotype 15B: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-3.3

upper limit

Descriptive comparison

Statistical analysis description

Serotype 12F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-8.2

upper limit

8.2

Descriptive comparison

Statistical analysis description

Serotype 11A: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

1.7

Descriptive comparison

Statistical analysis description

Serotype 10A: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-9.8

upper limit

8.6

Descriptive comparison

Statistical analysis description

Serotype 8: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

2.1

Descriptive comparison

Statistical analysis description

Serotype 23F: 2-Sided CI based on the Miettinen and Nurminen method for the difference in proportions expressed as a percentage.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

Percentage Difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.9

upper limit

5.1

Secondary: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3

Top of page

End point title

Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3

End point description

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Assay results below the LLOQ were set to 0.5*LLOQ. Dose 3 evaluable immunogenicity population included eligible subjects who were 2 to 6 months of age at the first vaccination, received the first 3 doses as randomised, had at least 1 valid immunogenicity results from the blood collection within 27 to 56 days after Dose 3, and had no other major protocol deviations per clinician. Here, number of subjects analysed=subjects with an IgG concentration >= predefined level for given serotype and ‘n’ =subjects with valid assay results for the specified serotype.

End point type

Secondary

End point timeframe

1 Month after Dose 3

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	221	220	213
Units: Micrograms per millilitre
geometric mean (confidence interval 95%)
Serotype 1 (n=221, 220, 213)	1.37 (1.25 to 1.51)	2.21 (1.98 to 2.47)	1.17 (1.04 to 1.31)
Serotype 3 (n=221, 220, 213)	1.29 (1.18 to 1.41)	1.81 (1.66 to 1.98)	1.10 (0.99 to 1.22)
Serotype 4 (n=221, 220, 213)	1.76 (1.57 to 1.97)	2.96 (2.64 to 3.32)	1.73 (1.52 to 1.97)
Serotype 5 (n=221, 220, 213)	1.01 (0.89 to 1.16)	1.72 (1.51 to 1.96)	1.00 (0.87 to 1.14)
Serotype 6A (n=221, 220, 213)	1.38 (1.21 to 1.57)	2.34 (2.09 to 2.62)	1.64 (1.42 to 1.88)
Serotype 6B (n=221, 220, 213)	0.42 (0.35 to 0.50)	0.83 (0.71 to 0.97)	0.39 (0.32 to 0.48)
Serotype 7F (n=221, 220, 213)	1.58 (1.43 to 1.75)	2.19 (1.95 to 2.46)	1.52 (1.35 to 1.71)
Serotype 9V (n=221, 220, 213)	1.46 (1.32 to 1.61)	2.11 (1.88 to 2.36)	1.45 (1.29 to 1.64)
Serotype 14 (n=220, 220, 213)	2.79 (2.45 to 3.18)	3.31 (2.90 to 3.78)	2.43 (2.13 to 2.76)
Serotype 18C (n=221, 220, 213)	1.67 (1.51 to 1.86)	2.52 (2.26 to 2.82)	1.54 (1.38 to 1.72)
Serotype 19A (n=221, 220, 213)	2.41 (2.19 to 2.65)	3.19 (2.86 to 3.56)	2.36 (2.11 to 2.64)
Serotype 19F (n=221, 220, 213)	2.81 (2.60 to 3.04)	3.73 (3.41 to 4.08)	2.76 (2.53 to 3.02)
Serotype 23F (n=221, 220, 213)	1.32 (1.15 to 1.51)	2.05 (1.79 to 2.34)	1.29 (1.13 to 1.48)
Serotype 8 (n=221, 219, 213)	3.32 (3.05 to 3.61)	0.01 (0.01 to 0.01)	3.29 (2.97 to 3.64)
Serotype 10A (n=221, 220, 213)	0.50 (0.42 to 0.60)	0.01 (0.01 to 0.02)	0.47 (0.39 to 0.56)
Serotype 11A (n=221, 220, 213)	5.63 (5.17 to 6.14)	0.02 (0.02 to 0.02)	5.22 (4.73 to 5.77)
Serotype 12F (n=221, 220, 213)	0.79 (0.67 to 0.93)	0.01 (0.01 to 0.01)	0.72 (0.60 to 0.85)
Serotype 15B (n=221, 220, 213)	6.77 (6.04 to 7.60)	0.04 (0.03 to 0.05)	6.80 (6.03 to 7.67)
Serotype 22F (n=221, 220, 213)	4.94 (4.54 to 5.38)	0.01 (0.00 to 0.01)	4.41 (3.99 to 4.88)
Serotype 33F (n=219, 220, 212)	1.70 (1.51 to 1.92)	0.02 (0.02 to 0.03)	1.62 (1.40 to 1.87)

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 1: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[33]

Method

Parameter type

GMR

Point estimate

0.62

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

0.72

Notes
[33] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 3: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[34]

Method

Parameter type

GMR

Point estimate

0.71

Confidence interval

level

95%

sides

2-sided

lower limit

0.63

upper limit

0.81

Notes
[34] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 4: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[35]

Method

Parameter type

GMR

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

0.7

Notes
[35] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 6B: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[36]

Method

Parameter type

GMR

Point estimate

0.51

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.64

Notes
[36] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 6A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[37]

Method

Parameter type

GMR

Point estimate

0.59

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

0.7

Notes
[37] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 5: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[38]

Method

Parameter type

GMR

Point estimate

0.59

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

0.71

Notes
[38] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 23F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[39]

Method

Parameter type

GMR

Point estimate

0.64

Confidence interval

level

95%

sides

2-sided

lower limit

0.53

upper limit

0.78

Notes
[39] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 8: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[40]

Method

Parameter type

GMR

Point estimate

4.01

Confidence interval

level

95%

sides

2-sided

lower limit

3.36

upper limit

4.79

Notes
[40] - For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 10A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[41]

Method

Parameter type

GMR

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

0.76

Notes
[41] - For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 19F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[42]

Method

Parameter type

GMR

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

0.85

Notes
[42] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 19A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[43]

Method

Parameter type

GMR

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

0.87

Notes
[43] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 18C: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[44]

Method

Parameter type

GMR

Point estimate

0.66

Confidence interval

level

95%

sides

2-sided

lower limit

0.57

upper limit

0.77

Notes
[44] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 14: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[45]

Method

Parameter type

GMR

Point estimate

0.84

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.01

Notes
[45] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 11A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[46]

Method

Parameter type

GMR

Point estimate

6.8

Confidence interval

level

95%

sides

2-sided

lower limit

5.69

upper limit

8.13

Notes
[46] - For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 7F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[47]

Method

Parameter type

GMR

Point estimate

0.72

Confidence interval

level

95%

sides

2-sided

lower limit

0.62

upper limit

0.84

Notes
[47] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 13 matched serotype

Statistical analysis description

Serotype 9V: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[48]

Method

Parameter type

GMR

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

0.8

Notes
[48] - Comparison for the 13 matched serotypes for 20vPnC (SC) is to the corresponding serotype in 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 22F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[49]

Method

Parameter type

GMR

Point estimate

5.97

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

7.12

Notes
[49] - For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 15B: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[50]

Method

Parameter type

GMR

Point estimate

8.18

Confidence interval

level

95%

sides

2-sided

lower limit

6.75

upper limit

9.92

Notes
[50] - For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 12F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[51]

Method

Parameter type

GMR

Point estimate

0.95

Confidence interval

level

95%

sides

2-sided

lower limit

0.76

upper limit

1.2

Notes
[51] - For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).

NI of 20vPnC(SC)-13vPnC(SC)for 7 add. serotype

Statistical analysis description

Serotype 33F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 13vPnC (SC)

Number of subjects included in analysis

441

Analysis specification

Pre-specified

Analysis type

non-inferiority ^[52]

Method

Parameter type

GMR

Point estimate

2.06

Confidence interval

level

95%

sides

2-sided

lower limit

1.69

upper limit

2.51

Notes
[52] - For the additional 7 serotypes, the compared results are from serotype 6B (13vPnC [SC] serotype with the lowest GMC, not including serotype 3) in the 13vPnC (SC) group. Noninferiority was declared if the lower bound of the 2-sided 95% CI for the GMR (20vPnC [SC]/lowest 13vPnC [SC]) was greater than 0.5 (2-fold criterion).

Descriptive comparison

Statistical analysis description

Serotype 7F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1.12

Descriptive comparison

Statistical analysis description

Serotype 6B: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.72

upper limit

1.21

Descriptive comparison

Statistical analysis description

Serotype 6A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

1.19

Confidence interval

level

95%

sides

2-sided

lower limit

0.98

upper limit

1.44

Descriptive comparison

Statistical analysis description

Serotype 5: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

1.19

Descriptive comparison

Statistical analysis description

Serotype 4: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

1.16

Descriptive comparison

Statistical analysis description

Serotype 3: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.85

Confidence interval

level

95%

sides

2-sided

lower limit

0.74

upper limit

0.98

Descriptive comparison

Statistical analysis description

Serotype 1: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.85

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

0.99

Descriptive comparison

Statistical analysis description

Serotype 9V: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

1.16

Descriptive comparison

Statistical analysis description

Serotype 14: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.87

Confidence interval

level

95%

sides

2-sided

lower limit

0.72

upper limit

1.04

Descriptive comparison

Statistical analysis description

Serotype 18C: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.92

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.07

Descriptive comparison

Statistical analysis description

Serotype 19A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.13

Descriptive comparison

Statistical analysis description

Serotype 19F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.1

Descriptive comparison

Statistical analysis description

Serotype 15B: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

1.18

Descriptive comparison

Statistical analysis description

Serotype 23F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

1.19

Descriptive comparison

Statistical analysis description

Serotype 12F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.71

upper limit

1.15

Descriptive comparison

Statistical analysis description

Serotype 11A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

1.06

Descriptive comparison

Statistical analysis description

Serotype 10A: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.94

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

1.2

Descriptive comparison

Statistical analysis description

Serotype 8: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.99

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.13

Descriptive comparison

Statistical analysis description

Serotype 33F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.95

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.15

Descriptive comparison

Statistical analysis description

Serotype 22F: 2-Sided CIs were calculated by exponentiating the mean differences of the logarithms of the IgG concentrations and the corresponding CIs based on the geometric mean ratio.

Comparison groups

20vPnC (SC) v 20vPnC (IM)

Number of subjects included in analysis

434

Analysis specification

Pre-specified

Analysis type

other

Method

Parameter type

GMR

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

1.02

Secondary: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4

Top of page

End point title

Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4

End point description

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. Dose 4 evaluable immunogenicity population included eligible subjects who were 2 to 6 months of age at Dose 1 and 12 to 15 months of age at Dose 4, received all 4 doses as randomised, had at least 1 valid assay result from the blood collection within 27 to 56 days after Dose 4, and had no other major protocol deviations per clinician. Here, number of subjects analysed=subjects with an IgG concentration >= predefined level for given serotype and ‘n’=subjects with valid assay results for the specified serotype.

End point type

Secondary

End point timeframe

1 Month after Dose 4

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	217	220	211
Units: Micrograms per millilitre
geometric mean (confidence interval 95%)
Serotype 1 (n=217, 220, 211)	2.79 (2.50 to 3.12)	4.62 (4.11 to 5.19)	2.78 (2.47 to 3.12)
Serotype 3 (n=217, 220, 211)	0.97 (0.87 to 1.08)	1.44 (1.30 to 1.59)	1.08 (0.96 to 1.21)
Serotype 4 (n=217, 220, 211)	6.93 (6.14 to 7.83)	10.01 (8.89 to 11.27)	7.31 (6.51 to 8.20)
Serotype 5 (n=217, 220, 211)	2.96 (2.63 to 3.34)	4.64 (4.13 to 5.21)	2.94 (2.59 to 3.33)
Serotype 6A (n=217, 220, 211)	11.90 (10.61 to 13.34)	17.25 (15.66 to 18.99)	13.92 (12.43 to 15.59)
Serotype 6B (n=216, 220, 211)	7.18 (6.30 to 8.18)	10.48 (9.46 to 11.61)	7.50 (6.58 to 8.55)
Serotype 7F (n=217, 220, 211)	4.46 (4.04 to 4.92)	6.62 (5.95 to 7.38)	4.85 (4.34 to 5.42)
Serotype 9V (n=217, 220, 211)	4.54 (4.04 to 5.09)	6.62 (5.93 to 7.39)	5.38 (4.81 to 6.02)
Serotype 14 (n=217, 220, 211)	8.23 (7.27 to 9.31)	10.30 (9.25 to 11.47)	9.19 (8.10 to 10.43)
Serotype 18C (n=217, 220, 211)	3.95 (3.50 to 4.45)	5.97 (5.27 to 6.75)	3.81 (3.38 to 4.30)
Serotype 19A (n=217, 219, 211)	7.62 (6.82 to 8.52)	8.97 (8.08 to 9.95)	7.92 (7.06 to 8.89)
Serotype 19F (n=217, 220, 211)	8.74 (7.84 to 9.73)	11.02 (9.96 to 12.20)	8.56 (7.66 to 9.56)
Serotype 23F (n=217, 220, 211)	7.01 (6.16 to 7.97)	11.76 (10.42 to 13.28)	7.39 (6.49 to 8.42)
Serotype 8 (n=217, 219, 211)	5.84 (5.23 to 6.53)	0.02 (0.02 to 0.03)	5.88 (5.23 to 6.62)
Serotype 10A (n=217, 220, 211)	6.98 (6.13 to 7.93)	0.01 (0.01 to 0.01)	8.02 (7.02 to 9.16)
Serotype 11A (n=217, 220, 211)	5.73 (5.08 to 6.46)	0.02 (0.01 to 0.02)	5.78 (5.14 to 6.50)
Serotype 12F (n=217, 220, 211)	2.73 (2.41 to 3.09)	0.01 (0.01 to 0.01)	2.69 (2.36 to 3.06)
Serotype 15B (n=217, 220, 211)	18.45 (16.73 to 20.36)	0.03 (0.03 to 0.04)	21.83 (19.53 to 24.41)
Serotype 22F (n=217, 220, 211)	14.07 (12.67 to 15.63)	0.00 (0.00 to 0.01)	14.21 (12.61 to 16.00)
Serotype 33F (n=217, 220, 211)	10.29 (9.28 to 11.40)	0.02 (0.01 to 0.02)	11.13 (9.99 to 12.39)

No statistical analyses for this end point

Secondary: Geometric Mean Titre (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4

Top of page

End point title

Geometric Mean Titre (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4

End point description

20vPnC serotypes included: 1,3,4,5,6A,6B,7F,8,9V,10A,11A,12F,14,15B,18C,19A,19F,22F,23F, and 33F. For 1 month after Dose 3 and before Dose 4, Dose 3 evaluable immunogenicity population set were analysed and and for 1 month after Dose 4, Dose 4 evaluable immunogenicity population set were analysed. OPA GMTs were determined in randomly selected subsets of sera from each vaccine group. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects with valid results for the specified serotype.

End point type

Secondary

End point timeframe

1 Month after Dose 3, before Dose 4 and 1 Month after Dose 4

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	73	75	72
Units: Titres
geometric mean (confidence interval 95%)
Serotype 1:1 Month after Dose 3 (n=71, 70,72)	55 (43 to 71)	126 (104 to 152)	56 (45 to 70)
Serotype 1:Before Dose 4 (n=71,71,71)	11 (10 to 12)	13 (11 to 16)	10 (9 to 11)
Serotype 1:1 Month after Dose 4 (n=70,72,68)	162 (125 to 210)	386 (306 to 486)	194 (150 to 251)
Serotype 3:1 Month after Dose 3 (n=71,70,72)	107 (86 to 134)	170 (147 to 196)	120 (103 to 139)
Serotype 3:Before Dose 4 (n=70,70,69)	16 (13 to 20)	20 (16 to 25)	16 (12 to 20)
Serotype 3: 1 Month after Dose 4 (n=68,70,66)	131 (114 to 150)	193 (165 to 226)	150 (126 to 179)
Serotype 4:1 Month after Dose 3 (n=71,72,65)	1864 (1565 to 2219)	1768 (1393 to 2245)	1617 (1298 to 2015)
Serotype 4: Before Dose 4 (n=68,67,70)	25 (18 to 37)	44 (29 to 66)	21 (15 to 28)
Serotype 4:1 Month after Dose 4 (n=70,71,67)	1627 (1232 to 2148)	2038 (1471 to 2825)	1544 (1224 to 1948)
Serotype 5:1 Month after Dose 3 (n=71,70,72)	95 (79 to 114)	154 (131 to 183)	91 (77 to 109)
Serotype 5:Before Dose 4 (n=71,71,71)	16 (15 to 17)	18 (16 to 19)	15 (14 to 16)
Serotype 5:1 Month after Dose 4 (n=70,72,68)	172 (140 to 212)	248 (204 to 303)	141 (112 to 179)
Serotype 6A:1 Month after Dose 3 (n=71,70,72)	2709 (2283 to 3213)	3339 (2777 to 4013)	3120 (2562 to 3799)
Serotype 6A:Before Dose 4 (n=67,70,66)	83 (56 to 122)	173 (116 to 258)	95 (62 to 147)
Serotype 6A:1 Month after Dose 4 (n=70,71,68)	3249 (2686 to 3928)	5455 (4379 to 6795)	3489 (2831 to 4300)
Serotype 6B:1 Month after Dose 3 (n=70,69,72)	1548 (1247 to 1921)	2489 (2005 to 3088)	1563 (1215 to 2010)
Serotype 6B:Before Dose 4 (n=68,65,70)	40 (29 to 54)	75 (49 to 115)	44 (31 to 63)
Serotype 6B:1 Month after Dose 4 (n=70,70,66)	2304 (1811 to 2933)	4319 (3478 to 5362)	2552 (2006 to 3247)
Serotype 7F:1 Month after Dose 3 (n=69,74,69)	4160 (3406 to 5081)	4428 (3821 to 5131)	4491 (3675 to 5490)
Serotype 7F:Before Dose 4 (n=65,70,69)	626 (436 to 899)	761 (579 to 1000)	689 (487 to 975)
Serotype 7F:1 Month after Dose 4 (n=70,71,67)	4735 (3824 to 5863)	6361 (5024 to 8054)	4703 (3704 to 5972)
Serotype 9V:1 Month after Dose 3 (n=72,74,67)	1807 (1432 to 2279)	2388 (1986 to 2870)	1929 (1554 to 2394)
Serotype 9V:Before Dose 4 (n=65,70,67)	183 (134 to 251)	204 (151 to 274)	212 (149 to 302)
Serotype 9V:1 Month after Dose 4 (n=70,70,68)	4199 (3322 to 5309)	5162 (4349 to 6127)	4201 (3418 to 5164)
Serotype 14:1 Month after Dose 3 (n=70,69,72)	1922 (1429 to 2585)	2593 (1999 to 3362)	2103 (1527 to 2897)
Serotype 14:Before Dose 4 (n=68,71,68)	426 (307 to 592)	469 (346 to 634)	357 (251 to 509)
Serotype 14:1 Month after Dose 4 (n=71,70,68)	1673 (1331 to 2102)	1706 (1385 to 2102)	2005 (1631 to 2463)
Serotype 18C:1 Month after Dose 3 (n=71,74,70)	5124 (4381 to 5992)	5355 (4617 to 6212)	4908 (4037 to 5967)
Serotype 18C:Before Dose 4 (n=65,69,68)	122 (76 to 198)	173 (112 to 267)	89 (56 to 143)
Serotype 18C:1 Month after Dose 4 (n=70,70,66)	4477 (3528 to 5681)	6315 (5081 to 7848)	4249 (3355 to 5381)
Serotype 19A:1 Month after Dose 3 (n=72,73,67)	638 (535 to 762)	676 (551 to 830)	553 (441 to 693)
Serotype 19A:Before Dose 4 (n=67,71,67)	13 (10 to 18)	20 (14 to 28)	12 (10 to 16)
Serotype 19A:1 Month after Dose 4 (n=71,72,68)	1860 (1530 to 2261)	2534 (2044 to 3143)	1722 (1379 to 2151)
Serotype 19F:1 Month after Dose 3 (n=71,70,71)	449 (356 to 566)	624 (494 to 788)	488 (411 to 580)
Serotype 19F:Before Dose 4 (n=70,70,70)	26 (24 to 29)	25 (24 to 26)	26 (23 to 29)
Serotype 19F:1 Month after Dose 4 (n=71,71,68)	1071 (846 to 1356)	1783 (1364 to 2331)	962 (753 to 1230)
Serotype 23F:1 Month after Dose 3 (n=72,74,71)	1580 (1211 to 2061)	1849 (1499 to 2281)	1402 (1103 to 1782)
Serotype 23F:Before Dose 4 (n=64,70,66)	42 (24 to 73)	62 (36 to 107)	24 (15 to 39)
Serotype 23F:1 Month after Dose 4 (n=71,70,68)	2609 (2015 to 3377)	3772 (2966 to 4796)	2052 (1668 to 2523)
Serotype 8:1 Month after Dose 3 (n=70,72,66)	1532 (1215 to 1933)	16 (15 to 18)	1541 (1220 to 1946)
Serotype 8:Before Dose 4 (n=65,73,65)	166 (119 to 230)	20 (17 to 24)	147 (105 to 205)
Serotype 8:1 Month after Dose 4 (n=64,71,64)	2970 (2412 to 3658)	27 (20 to 36)	3208 (2525 to 4077)
Serotype 10A:1 Month after Dose 3 (n=63,75,63)	6977 (5204 to 9354)	40 (33 to 47)	6780 (5436 to 8456)
Serotype 10A:Before Dose 4 (n=61,70,62)	1985 (1422 to 2772)	78 (51 to 118)	2066 (1439 to 2967)
Serotype 10A:1 Month after Dose 4 (n=61,68,58)	9030 (6855 to 11893)	87 (56 to 136)	8269 (6252 to 10937)
Serotype 11A:1 Month after Dose 3 (n=73,73,67)	1894 (1540 to 2330)	58 (47 to 71)	1838 (1451 to 2327)
Serotype 11A:Before Dose 4 (n=70,70,64)	416 (258 to 670)	95 (64 to 142)	247 (150 to 405)
Serotype 11A: 1 Month after Dose 4 (n=70,69,65)	3958 (2973 to 5269)	90 (62 to 132)	4200 (3187 to 5534)
Serotype 12F:1 Month after Dose 3 (n=46,75,44)	35278 (23575 to 52790)	24 (24 to 25)	21475 (14378 to 32074)
Serotype 12F:Before Dose 4 (n=58,69,64)	3984 (3017 to 5261)	35 (26 to 47)	4904 (3909 to 6153)
Serotype 12F:1 Month after Dose 4 (n=57,74,47)	15611 (11336 to 21499)	43 (31 to 60)	18899 (14215 to 25125)
Serotype 15B:1 Month after Dose 3 (n=71,74,66)	6981 (5726 to 8511)	17 (15 to 20)	5707 (4129 to 7889)
Serotype 15B:Before Dose 4 (n=64,73,65)	578 (345 to 969)	26 (18 to 39)	609 (331 to 1121)
Serotype 15B:1 Month after Dose 4 (n=65,71,61)	7280 (5594 to 9475)	32 (20 to 50)	7770 (6448 to 9363)
Serotype 22F:1 Month after Dose 3 (n=62,75,61)	21864 (16413 to 29125)	10 (8 to 11)	19276 (14969 to 24822)
Serotype 22F:Before Dose 4 (n=66,72,64)	2562 (1869 to 3512)	16 (11 to 24)	2014 (1477 to 2745)
Serotype 22F:1 Month after Dose 4 (n=58,74,52)	28435 (19414 to 41649)	18 (12 to 27)	23480 (17229 to 31998)
Serotype 33F:1 Month after Dose 3 (57,71,59)	20162 (13581 to 29930)	177 (160 to 195)	15931 (11550 to 21974)
Serotype 33F:Before Dose 4 (n=56,72,60)	5678 (4403 to 7321)	539 (391 to 742)	6835 (5080 to 9198)
Serotype 33F:1 Month after Dose 4 (n=63,71,55)	18997 (13140 to 27463)	658 (480 to 904)	26963 (18722 to 38830)

No statistical analyses for this end point

Secondary: Percentage of Subjects With Pre-defined Pneumococcal IgG concentrations at 1 Month After Dose 4

Top of page

End point title

Percentage of Subjects With Pre-defined Pneumococcal IgG concentrations at 1 Month After Dose 4

End point description

Pneumococcal serotype-specific IgG concentrations were measured for 20vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F. The predefined levels, 0.35 micrograms/mL for all serotypes except for serotypes 5 (>=0.23 micrograms/mL), 6B (>=0.10 micrograms/mL) and 19A (>=0.12 micrograms/mL). Dose 4 evaluable immunogenicity population included subjects who were eligible randomised aged 2 to 6 months of age at the first vaccination, received all 4 randomised vaccines with Dose 4 received within the defined window 12 to 15 months of age, had at least 1 immunogenicity results within 27 to 56 days, inclusive, after Dose 4, and had no other major protocol deviations per clinician. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects with valid results for the specified serotype.

End point type

Secondary

End point timeframe

1 Month after Dose 4

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	217	220	211
Units: Percentage of subjects
number (not applicable)
Serotype 1 (n=217, 220, 211)	99.1	100.0	98.6
Serotype 3 (n=217, 220, 211)	91.7	98.6	91.5
Serotype 4 (n=217, 220, 211)	100.0	100.0	100.0
Serotype 5 (n=217, 220, 211)	99.5	100.0	99.5
Serotype 6A (n=217, 220, 211)	100.0	100.0	100.0
Serotype 6B (n=216, 220, 211)	100.0	100.0	100.0
Serotype 7F (n=217, 220, 211)	99.5	100.0	100.0
Serotype 9V (n=217, 220, 211)	99.5	100.0	100.0
Serotype 14 (n=217, 220, 211)	99.1	99.5	100.0
Serotype 18C (n=217, 220, 211)	99.5	100.0	100.0
Serotype 19A (n=217, 219, 211)	100.0	100.0	100.0
Serotype 19F (n=217, 220, 211)	100.0	100.0	100.0
Serotype 23F (n=217, 220, 211)	99.5	100.0	99.5
Serotype 8 (n=217, 219, 211)	100.0	3.2	100.0
Serotype 10A (n=217, 220, 211)	99.1	0.9	99.5
Serotype 11A (n=217, 220, 211)	100.0	5.9	100.0
Serotype 12F (n=217, 220, 211)	98.2	0.0	98.6
Serotype 15B (n=217, 220, 211)	100.0	8.6	100.0
Serotype 22F (n=217, 220, 211)	100.0	1.8	100.0
Serotype 33F (n=217, 220, 211)	100.0	2.7	100.0

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4

Top of page

End point title

Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4

End point description

GMFR of pneumococcal 20vPnC serotypes included: 1,3,4,5,6A,6B,7F,8,9V,10A,11A,12F,14,15B,18C,19A,19F,22F,23F,and 33F. The GMFR from 1 month after Dose 3 to before Dose 4 was reported from subjects in Dose 3 evaluable immunogenicity population. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects with valid IgG concentration at both timepoints for the specified serotype.

End point type

Secondary

End point timeframe

1 Month after Dose 3 to before Dose 4

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	218	219	212
Units: Fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 218 , 219, 212)	0.2 (0.2 to 0.2)	0.2 (0.2 to 0.2)	0.2 (0.2 to 0.2)
Serotype 3 (n = 218, 219, 212)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)
Serotype 4 (n = 218, 219 ,212)	0.3 (0.2 to 0.3)	0.2 (0.2 to 0.3)	0.3 (0.2 to 0.3)
Serotype 5 (n = 218, 219, 211)	0.3 (0.2 to 0.3)	0.2 (0.2 to 0.3)	0.2 (0.2 to 0.3)
Serotype 6A (n = 218, 219, 212)	0.5 (0.4 to 0.6)	0.4 (0.4 to 0.4)	0.4 (0.3 to 0.4)
Serotype 6B (n = 216, 217 ,212)	0.8 (0.6 to 0.9)	0.5 (0.4 to 0.6)	0.7 (0.6 to 0.8)
Serotype 7F (n = 218, 219, 212)	0.5 (0.4 to 0.5)	0.4 (0.4 to 0.5)	0.5 (0.4 to 0.5)
Serotype 9V (n = 218 ,219, 212)	0.3 (0.2 to 0.3)	0.3 (0.2 to 0.3)	0.3 (0.2 to 0.3)
Serotype 14 (n = 217, 219, 212)	0.7 (0.6 to 0.8)	0.7 (0.6 to 0.8)	0.7 (0.6 to 0.8)
Serotype 18C (n = 218, 219, 212)	0.2 (0.2 to 0.2)	0.2 (0.2 to 0.2)	0.2 (0.2 to 0.2)
Serotype 19A (n = 218, 219, 212)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)	0.1 (0.1 to 0.1)
Serotype 19F (n = 218, 219, 212)	0.2 (0.1 to 0.2)	0.1 (0.1 to 0.2)	0.2 (0.1 to 0.2)
Serotype 23F (n = 218, 219, 212)	0.2 (0.2 to 0.3)	0.3 (0.2 to 0.3)	0.3 (0.2 to 0.3)
Serotype 8 (n = 218, 216, 212)	0.2 (0.1 to 0.2)	1.4 (1.2 to 1.6)	0.2 (0.1 to 0.2)
Serotype 10A (n = 218, 219, 212)	2.2 (1.9 to 2.6)	0.8 (0.6 to 0.9)	2.3 (1.9 to 2.7)
Serotype 11A (n = 218, 219, 212)	0.1 (0.1 to 0.2)	0.8 (0.6 to 0.9)	0.1 (0.1 to 0.2)
Serotype 12F (n = 218, 219, 212)	0.4 (0.3 to 0.5)	1.0 (0.9 to 1.1)	0.4 (0.3 to 0.4)
Serotype 15B (n = 218, 219, 212)	0.4 (0.4 to 0.5)	0.6 (0.5 to 0.7)	0.4 (0.3 to 0.4)
Serotype 22F (n = 218, 219, 212)	0.4 (0.3 to 0.4)	0.6 (0.5 to 0.8)	0.4 (0.3 to 0.4)
Serotype 33F (n = 216, 219, 211)	1.1 (0.9 to 1.2)	0.6 (0.5 to 0.7)	1.0 (0.9 to 1.2)

No statistical analyses for this end point

Secondary: GMFR in Serotype-Specific IgG Concentrations 1 Month After Dose 3 to 1 Month After Dose 4

Top of page

End point title

GMFR in Serotype-Specific IgG Concentrations 1 Month After Dose 3 to 1 Month After Dose 4

End point description

GMFR of pneumococcal 20vPnC serotypes included: 1,3,4,5,6A,6B,7F,8,9V,10A,11A,12F,14,15B,18C,19A,19F,22F,23F,and 33F. The GMFR from 1 month after Dose 3 to 1 month after Dose 4 was reported from subjects in both the Dose 3 and Dose 4 evaluable immunogenicity populations. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects with valid IgG concentrations at both timepoints for the specified serotype.

End point type

Secondary

End point timeframe

From 1 Month after Dose 3 to 1 Month after Dose 4

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	218	219	212
Units: Fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 216, 219, 209)	2.0 (1.8 to 2.2)	2.1 (1.9 to 2.3)	2.4 (2.2 to 2.7)
Serotype 3 (n = 216, 219, 209)	0.7 (0.7 to 0.8)	0.8 (0.7 to 0.9)	1.0 (0.9 to 1.1)
Serotype 4 (n = 216, 219, 209)	3.9 (3.4 to 4.4)	3.4 (3.0 to 3.8)	4.3 (3.7 to 4.8)
Serotype 5 (n = 216, 219, 209)	2.9 (2.6 to 3.3)	2.7 (2.4 to 3.0)	3.0 (2.6 to 3.4)
Serotype 6A (n = 216, 219, 209)	8.6 (7.5 to 9.8)	7.3 (6.5 to 8.3)	8.6 (7.6 to 9.8)
Serotype 6B (n = 215, 219, 209)	17.1 (14.3 to 20.4)	12.6 (10.8 to 14.7)	19.5 (16.2 to 23.5)
Serotype 7F (n = 216, 219, 209)	2.8 (2.6 to 3.1)	3.0 (2.7 to 3.3)	3.3 (2.9 to 3.6)
Serotype 9V (n = 216, 219, 209)	3.1 (2.8 to 3.5)	3.1 (2.8 to 3.5)	3.8 (3.4 to 4.2)
Serotype 14 (n = 215, 219, 209)	2.9 (2.6 to 3.4)	3.1 (2.7 to 3.6)	3.9 (3.3 to 4.5)
Serotype 18C (n = 216, 219, 209)	2.3 (2.1 to 2.6)	2.4 (2.1 to 2.6)	2.5 (2.3 to 2.8)
Serotype 19A (n = 216, 218, 209)	3.2 (2.8 to 3.6)	2.8 (2.5 to 3.1)	3.4 (3.0 to 3.8)
Serotype 19F (n = 216, 219, 209)	3.1 (2.8 to 3.4)	2.9 (2.6 to 3.3)	3.1 (2.8 to 3.5)
Serotype 23F (n = 216, 219, 209)	5.3 (4.6 to 6.1)	5.7 (5.0 to 6.5)	5.8 (5.1 to 6.6)
Serotype 8 (n = 216, 217, 209)	1.8 (1.6 to 2.0)	1.7 (1.5 to 2.0)	1.8 (1.6 to 2.0)
Serotype 10A (n = 216, 219, 209)	14.0 (11.8 to 16.5)	0.8 (0.7 to 1.0)	17.5 (14.7 to 20.7)
Serotype 11A (n = 216, 219, 209)	1.0 (0.9 to 1.1)	0.8 (0.7 to 1.0)	1.1 (1.0 to 1.2)
Serotype 12F (n = 216, 219, 209)	3.4 (3.0 to 3.9)	1.0 (1.0 to 1.1)	3.9 (3.4 to 4.4)
Serotype 15B (n = 216, 219, 209)	2.7 (2.4 to 3.1)	0.9 (0.7 to 1.1)	3.3 (2.9 to 3.7)
Serotype 22F (n = 216, 219, 209)	2.9 (2.6 to 3.1)	0.7 (0.6 to 0.9)	3.2 (2.9 to 3.6)
Serotype 33F (n = 214, 219, 208)	6.0 (5.3 to 6.7)	0.7 (0.6 to 0.9)	7.1 (6.2 to 8.1)

No statistical analyses for this end point

Secondary: GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4

Top of page

End point title

GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4

End point description

GMFR of pneumococcal 20vPnC serotypes included: 1,3,4,5,6A,6B,7F,8,9V,10A,11A,12F,14,15B,18C,19A,19F,22F,23F,and 33F. The GMFR from before Dose 4 to 1 month after Dose 4 was reported from subjects in the Dose 4 evaluable immunogenicity population. Here, number of subjects analysed=subjects evaluable for this endpoint and n=subjects with valid IgG concentrations at both timepoints for the specified serotype.

End point type

Secondary

End point timeframe

From before Dose 4 to 1 Month after Dose 4

End point values	20vPnC (SC)	13vPnC (SC)	20vPnC (IM)
Number of subjects analysed	217	220	211
Units: Fold rise
geometric mean (confidence interval 95%)
Serotype 1 (n = 217, 220, 211)	10.7 (9.6 to 11.9)	12.1 (11.0 to 13.3)	12.6 (11.3 to 14.0)
Serotype 3 (n = 217, 220, 211)	7.5 (6.6 to 8.4)	7.9 (7.1 to 8.8)	8.9 (8.0 to 10.0)
Serotype 4 (n = 217, 220, 211)	15.0 (13.2 to 17.1)	14.3 (12.7 to 16.0)	16.5 (14.8 to 18.5)
Serotype 5 (n = 217, 220, 210)	10.8 (9.8 to 12.0)	11.8 (10.7 to 13.1)	12.2 (11.0 to 13.6)
Serotype 6A (n = 217, 220, 211)	17.6 (15.7 to 19.6)	18.4 (16.6 to 20.5)	22.1 (19.8 to 24.7)
Serotype 6B (n = 215, 218, 211)	22.3 (19.9 to 24.9)	24.3 (21.9 to 27.0)	26.9 (23.9 to 30.2)
Serotype 7F (n = 217, 220, 211)	6.0 (5.5 to 6.6)	7.2 (6.5 to 8.0)	6.8 (6.2 to 7.5)
Serotype 9V (n = 217, 220, 211)	11.8 (10.5 to 13.2)	12.0 (10.8 to 13.3)	13.9 (12.4 to 15.6)
Serotype 14 (n = 217, 220, 211)	4.3 (3.8 to 4.9)	4.4 (3.9 to 5.0)	5.7 (5.0 to 6.6)
Serotype 18C (n = 217, 220, 211)	11.7 (10.5 to 12.9)	14.0 (12.7 to 15.4)	12.7 (11.5 to 14.1)
Serotype 19A (n = 217, 219, 211)	34.2 (30.0 to 38.9)	37.6 (33.2 to 42.6)	38.3 (33.4 to 44.0)
Serotype 19F (n = 217, 220, 211)	18.8 (16.6 to 21.4)	21.4 (19.0 to 24.2)	19.9 (17.6 to 22.4)
Serotype 23F (n = 217, 220, 211)	22.6 (20.1 to 25.5)	22.6 (19.8 to 25.7)	22.7 (20.1 to 25.7)
Serotype 8 (n = 217, 218, 211)	10.8 (9.6 to 12.1)	1.3 (1.2 to 1.4)	11.2 (9.9 to 12.7)
Serotype 10A (n = 217, 220, 211)	6.3 (5.6 to 7.1)	1.1 (1.0 to 1.1)	7.4 (6.6 to 8.3)
Serotype 11A (n = 217, 220, 211)	7.0 (6.2 to 7.9)	1.1 (1.0 to 1.2)	8.1 (7.2 to 9.1)
Serotype 12F (n = 217, 220, 211)	8.5 (7.6 to 9.4)	1.0 (1.0 to 1.1)	9.9 (8.9 to 10.9)
Serotype 15B (n = 217, 220, 211)	6.8 (6.0 to 7.7)	1.5 (1.3 to 1.6)	8.7 (7.6 to 10.0)
Serotype 22F (n = 217, 220, 211)	7.9 (7.1 to 8.8)	1.2 (1.1 to 1.3)	8.9 (8.1 to 9.9)
Serotype 33F (n = 217, 220, 211)	5.7 (5.1 to 6.3)	1.2 (1.1 to 1.3)	6.9 (6.2 to 7.8)

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

LR and SE [systematic assessment (SA)] within 7 days after Dose 1, 2, 3, or 4; SAEs (non-SA): from Day 1 up to 1 month after Dose 4; other AEs (non-SA): from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4

Adverse event reporting additional description

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

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

20vPnC (SC)

Reporting group description

Subjects received 4 doses of 0.5 mL 20vPnC SC into the anterolateral thigh. The time interval between Dose 1, 2 and 3 was 4 to 8 weeks from the previous vaccination. Subjects completed Dose 1, 2 and 3 by 12 months of age. Dose 4 was administered at least after 60 days of Dose 3.

Reporting group title

20vPnC (IM)

Reporting group description

Reporting group title

13vPnC (SC)

Reporting group description

Serious adverse events	20vPnC (SC)	20vPnC (IM)	13vPnC (SC)
Total subjects affected by serious adverse events
subjects affected / exposed	14 / 225 (6.22%)	16 / 217 (7.37%)	9 / 224 (4.02%)
number of deaths (all causes)	0	1	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Burns second degree
subjects affected / exposed	1 / 225 (0.44%)	0 / 217 (0.00%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Near drowning
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Clavicle fracture
subjects affected / exposed	1 / 225 (0.44%)	0 / 217 (0.00%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Congenital mitral valve incompetence
subjects affected / exposed	0 / 225 (0.00%)	0 / 217 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Patent ductus arteriosus
subjects affected / exposed	0 / 225 (0.00%)	0 / 217 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laryngomalacia
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Kawasaki's disease
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Cardio-respiratory arrest
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Nervous system disorders
Febrile convulsion
subjects affected / exposed	2 / 225 (0.89%)	0 / 217 (0.00%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Pyrexia
subjects affected / exposed	1 / 225 (0.44%)	2 / 217 (0.92%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Immune system disorders
Milk allergy
subjects affected / exposed	0 / 225 (0.00%)	0 / 217 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Food allergy
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	1 / 225 (0.44%)	1 / 217 (0.46%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Tuberculid
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Croup infectious
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Asymptomatic COVID-19
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchiolitis
subjects affected / exposed	0 / 225 (0.00%)	0 / 217 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 225 (0.00%)	0 / 217 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis orbital
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infectious mononucleosis
subjects affected / exposed	0 / 225 (0.00%)	0 / 217 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Exanthema subitum
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngitis
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	0 / 225 (0.00%)	2 / 217 (0.92%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus infection
subjects affected / exposed	4 / 225 (1.78%)	1 / 217 (0.46%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory syncytial virus bronchiolitis
subjects affected / exposed	4 / 225 (1.78%)	1 / 217 (0.46%)	2 / 224 (0.89%)
occurrences causally related to treatment / all	0 / 4	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	0 / 224 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 225 (0.00%)	1 / 217 (0.46%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia respiratory syncytial viral
subjects affected / exposed	1 / 225 (0.44%)	0 / 217 (0.00%)	1 / 224 (0.45%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	20vPnC (SC)	20vPnC (IM)	13vPnC (SC)
Total subjects affected by non serious adverse events
subjects affected / exposed	222 / 225 (98.67%)	211 / 217 (97.24%)	223 / 224 (99.55%)
Nervous system disorders
Hypersomnia (INCREASED SLEEP)
alternative assessment type: Systematic
subjects affected / exposed	147 / 225 (65.33%)	154 / 217 (70.97%)	161 / 224 (71.88%)
occurrences all number	343	389	410
General disorders and administration site conditions
Injection site pain (PAIN)
alternative assessment type: Systematic
subjects affected / exposed	84 / 225 (37.33%)	65 / 217 (29.95%)	85 / 224 (37.95%)
occurrences all number	167	118	166
Injection site erythema (REDNESS)
alternative assessment type: Systematic
subjects affected / exposed	217 / 225 (96.44%)	130 / 217 (59.91%)	217 / 224 (96.88%)
occurrences all number	762	297	784
Pyrexia (FEVER)
alternative assessment type: Systematic
subjects affected / exposed	136 / 225 (60.44%)	110 / 217 (50.69%)	135 / 224 (60.27%)
occurrences all number	219	197	219
Injection site swelling (SWELLING)
alternative assessment type: Systematic
subjects affected / exposed	206 / 225 (91.56%)	119 / 217 (54.84%)	211 / 224 (94.20%)
occurrences all number	723	251	729
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
subjects affected / exposed	18 / 225 (8.00%)	15 / 217 (6.91%)	11 / 224 (4.91%)
occurrences all number	22	19	14
Skin and subcutaneous tissue disorders
Eczema infantile
subjects affected / exposed	6 / 225 (2.67%)	13 / 217 (5.99%)	16 / 224 (7.14%)
occurrences all number	6	14	18
Eczema
subjects affected / exposed	22 / 225 (9.78%)	32 / 217 (14.75%)	19 / 224 (8.48%)
occurrences all number	25	33	19
Psychiatric disorders
Irritability (IRRITABILITY)
alternative assessment type: Systematic
subjects affected / exposed	110 / 225 (48.89%)	107 / 217 (49.31%)	119 / 224 (53.13%)
occurrences all number	291	282	295
Infections and infestations
Nasopharyngitis
subjects affected / exposed	49 / 225 (21.78%)	66 / 217 (30.41%)	64 / 224 (28.57%)
occurrences all number	72	96	85
Bronchitis
subjects affected / exposed	8 / 225 (3.56%)	11 / 217 (5.07%)	8 / 224 (3.57%)
occurrences all number	10	11	9
Upper respiratory tract infection
subjects affected / exposed	12 / 225 (5.33%)	8 / 217 (3.69%)	8 / 224 (3.57%)
occurrences all number	22	14	10
Metabolism and nutrition disorders
Decreased appetite (DECREASED APPETITE)
alternative assessment type: Systematic
subjects affected / exposed	62 / 225 (27.56%)	55 / 217 (25.35%)	68 / 224 (30.36%)
occurrences all number	99	94	118

More information

Top of page

Were there any global substantial amendments to the protocol? No

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 3, Randomized, Double-blind, Third Party Unblind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects With Local Reactions (LR) Within 7 Days After Dose 1

Primary: Percentage of Subjects With Local Reactions (LR) Within 7 Days After Dose 1

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 3

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 3

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 4

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 4

Primary: Percentage of Subjects With Systemic Events (SE) Within 7 Days After Dose 1

Primary: Percentage of Subjects With Systemic Events (SE) Within 7 Days After Dose 1

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 3

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 3

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 4

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 4

Primary: Percentage of Subjects With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3

Primary: Percentage of Subjects With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3

Primary: Percentage of Subjects With AEs from Dose 4 to 1 Month After Dose 4

Primary: Percentage of Subjects With AEs from Dose 4 to 1 Month After Dose 4

Primary: Percentage of Subjects With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4

Primary: Percentage of Subjects With Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 4

Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4

Primary: Percentage of Subjects With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 1 Month After Dose 4

Primary: Percentage of Subjects With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3

Primary: Percentage of Subjects With Predefined Pneumococcal Serotype-specific Immunoglobulin G (IgG) Concentrations 1 Month After Dose 3

Secondary: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3

Secondary: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 3

Secondary: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4

Secondary: Geometric Mean Concentration of Pneumococcal Serotype-Specific IgG Concentrations 1 Month After Dose 4

Secondary: Geometric Mean Titre (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4

Secondary: Geometric Mean Titre (GMTs) of Serotype Specific Opsonophagocytic Activity (OPA) at 1 Month After Dose 3, Before Dose 4 and 1 Month After Dose 4

Secondary: Percentage of Subjects With Pre-defined Pneumococcal IgG concentrations at 1 Month After Dose 4

Secondary: Percentage of Subjects With Pre-defined Pneumococcal IgG concentrations at 1 Month After Dose 4

Secondary: Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4

Secondary: Geometric Mean Fold Rise (GMFR) in Serotype-Specific IgG Concentrations From 1 Month After Dose 3 to Before Dose 4

Secondary: GMFR in Serotype-Specific IgG Concentrations 1 Month After Dose 3 to 1 Month After Dose 4

Secondary: GMFR in Serotype-Specific IgG Concentrations 1 Month After Dose 3 to 1 Month After Dose 4

Secondary: GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4

Secondary: GMFR in Serotype-Specific IgG Concentrations From Before Dose 4 to 1 Month After Dose 4

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, Third Party Unblind Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants