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Clinical Trial Results:
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

Summary
EudraCT number	2022-000845-34
Trial protocol	Outside EU/EEA
Global end of trial date	14 Dec 2021

Results information
Results version number	v1(current)
This version publication date	17 Dec 2022
First version publication date	17 Dec 2022
Other versions

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

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Trial information

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Sponsor protocol code

B1851196

ISRCTN number

US NCT number

NCT05372575

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, +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc, +1 8007181021, ClinicalTrials.gov_Inquiries@pfizer.com

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

14 Dec 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

14 Dec 2021

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to describe the antibody levels as measured by immunoglobulin G (IgG) and multiplex opsonophagocytic activity (MOPA) by 13-valent pneumococcal conjugate vaccine (13vPnC) vaccination status and vaccine type (VT) carriage status, among children 5 months to <=60 months of age with diagnosis of clinical pneumonia per local standard.

Protection of trial subjects

This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial subjects.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Aug 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

China: 300

Worldwide total number of subjects

300

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)

164

Children (2-11 years)

136

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Children hospitalized with a diagnosis of clinical pneumonia were considered for the study. Subjects participated in the study for 1 day. Subjects were followed for 12 hours after blood draw and deep respiratory aspirate if collected as a study procedure. A total of 300 subjects were enrolled in this study.

Screening details

No vaccines were administered during the study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

13vPnC Cohort

Arm description

The vaccination history of 13vPnC initially was obtained either from the subject's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnc vaccination was confirmed as received, and all other inclusion/exclusion criteria were met, this subject was enrolled and assigned to the vaccinated group (ie, 13vPnC Cohort). No vaccines were administered during the study.

Arm type

Experimental

Investigational medicinal product name

13vPnC

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

No study intervention was administered during the study.

Non-13vPnC Cohort

Arm description

The vaccination history of 13vPnC initially was obtained either from the subject's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this subject was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Number of subjects in period 1	13vPnC Cohort	Non-13vPnC Cohort
Started	101	199
Completed	94	183
Not completed	7	16
Protocol deviation	7	16

Baseline characteristics

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Reporting group title

13vPnC Cohort

Reporting group description

Reporting group title

Non-13vPnC Cohort

Reporting group description

The vaccination history of 13vPnC initially was obtained either from the subject's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this subject was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.

Reporting group values	13vPnC Cohort	Non-13vPnC Cohort	Total
Number of subjects	101	199	300
Age Categorical
Units: Subjects
<=4 months	1	0	1
5-12 months	27	50	77
13-24 months	39	49	88
25-60 months	34	100	134
Sex: Female, Male
Units: Subjects
Female	48	94	142
Male	53	105	158
Race/Ethnicity, Customized
Units: Subjects
Asian	101	199	300
Race/Ethnicity, Customized
Units: Subjects
Non-Hispanic/non-Latino	101	199	300

End points

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Reporting group title

13vPnC Cohort

Reporting group description

Reporting group title

Non-13vPnC Cohort

Reporting group description

The vaccination history of 13vPnC initially was obtained either from the subject's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this subject was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). No vaccines were administered during the study.

Subject analysis set title

13vPnC Cohort: VT+ Subgroup

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

13vPnC Cohort: VT- or Sp- Subgroup

Subject analysis set type

Sub-group analysis

Subject analysis set description

Subject analysis set title

Non-13vPnC Cohort: VT+ Subgroup

Subject analysis set type

Sub-group analysis

Subject analysis set description

The vaccination history of 13vPnC initially was obtained either from the sujbect's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this subject was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Subjects in this subgroup had a 13vPnC VT strain isolated from the respiratory tract (VT+). No vaccines were administered during the study.

Subject analysis set title

Non-13vPnC Cohort: VT- or Sp- Subgroup

Subject analysis set type

Sub-group analysis

Subject analysis set description

The vaccination history of 13vPnC initially was obtained either from the subject's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this subject was enrolled and assigned to the unvaccinated group (ie, Non-13vPnC Cohort). Subjects in this subgroup had no 13vPnC VT strain isolated from the respiratory tract (VT-) or had negative S. pneumoniae (Sp-). No vaccines were administered during the study.

Primary: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort

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End point title

Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort

End point description

Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all subjects with a collected blood sample. Analysis population for this endpiont included all subjects who signed the informed consent document (ICD), met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of subjects analyzed indicates the total number of subjects in this analysis population.

End point type

Primary

End point timeframe

Day 1

End point values	13vPnC Cohort	Non-13vPnC Cohort
Number of subjects analysed	92 ^[1]	184 ^[2]
Units: microgram per milliliter (μg/mL)
geometric mean (confidence interval 95%)
Serotype: 1 (n=92,179)	1.55 (1.17 to 2.06)	0.12 (0.09 to 0.15)
Serotype: 3 (n=92,184)	0.42 (0.32 to 0.54)	0.07 (0.06 to 0.08)
Serotype: 4 (n=92,184)	1.36 (1.00 to 1.84)	0.08 (0.06 to 0.10)
Serotype: 5 (n=92,184)	1.74 (1.41 to 2.15)	0.72 (0.63 to 0.82)
Serotype: 6A (n=92,183)	2.42 (1.85 to 3.15)	0.38 (0.33 to 0.44)
Serotype: 6B (n=92,184)	2.47 (1.90 to 3.22)	0.37 (0.32 to 0.43)
Serotype: 7F (n=92,183)	1.81 (1.41 to 2.32)	0.19 (0.16 to 0.23)
Serotype: 9V (n=92,184)	1.18 (0.96 to 1.46)	0.30 (0.26 to 0.36)
Serotype: 14 (n=92,180)	4.67 (3.40 to 6.42)	0.08 (0.06 to 0.10)
Serotype: 18C (n=92,182)	1.03 (0.79 to 1.34)	0.06 (0.05 to 0.08)
Serotype: 19A (n=92,184)	3.19 (2.50 to 4.07)	0.75 (0.65 to 0.86)
Serotype: 19F (n=92,181)	3.31 (2.53 to 4.31)	0.38 (0.31 to 0.46)
Serotype: 23F (n=92,184)	2.04 (1.56 to 2.68)	0.25 (0.21 to 0.28)

Notes
[1] - Subjects with available data (n=X,X in category titles) were analyzed.
[2] - Subjects with available data (n=X,X in category titles) were analyzed.

Geometric Mean Ratio (GMR) for Serotype: 1

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

Method

Parameter type

Geometric Mean Ratio (GMR)

Point estimate

13.16

Confidence interval

level

95%

sides

2-sided

lower limit

8.99

upper limit

19.28

Notes
[3] - The 2-sided 95% confidential interval (CI) on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[4]

Method

Parameter type

GMR

Point estimate

5.88

Confidence interval

level

95%

sides

2-sided

lower limit

4.32

upper limit

8.01

Notes
[4] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

Method

Parameter type

GMR

Point estimate

17.98

Confidence interval

level

95%

sides

2-sided

lower limit

12.07

upper limit

26.78

Notes
[5] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[6]

Method

Parameter type

GMR

Point estimate

2.42

Confidence interval

level

95%

sides

2-sided

lower limit

1.9

upper limit

3.08

Notes
[6] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

Method

Parameter type

GMR

Point estimate

6.35

Confidence interval

level

95%

sides

2-sided

lower limit

4.68

upper limit

8.61

Notes
[7] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[8]

Method

Parameter type

GMR

Point estimate

6.64

Confidence interval

level

95%

sides

2-sided

lower limit

4.92

upper limit

8.97

Notes
[8] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[9]

Method

Parameter type

GMR

Point estimate

9.42

Confidence interval

level

95%

sides

2-sided

lower limit

6.91

upper limit

12.83

Notes
[9] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[10]

Method

Parameter type

GMR

Point estimate

3.89

Confidence interval

level

95%

sides

2-sided

lower limit

2.96

upper limit

5.1

Notes
[10] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[11]

Method

Parameter type

GMR

Point estimate

62.13

Confidence interval

level

95%

sides

2-sided

lower limit

40.16

upper limit

96.12

Notes
[11] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[12]

Method

Parameter type

GMR

Point estimate

16.37

Confidence interval

level

95%

sides

2-sided

lower limit

11.22

upper limit

23.89

Notes
[12] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[13]

Method

Parameter type

GMR

Point estimate

4.25

Confidence interval

level

95%

sides

2-sided

lower limit

3.22

upper limit

5.62

Notes
[13] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[14]

Method

Parameter type

GMR

Point estimate

8.73

Confidence interval

level

95%

sides

2-sided

lower limit

6.24

upper limit

12.21

Notes
[14] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMC of 13vPnC Cohort)/(GMC of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[15]

Method

Parameter type

GMR

Point estimate

8.33

Confidence interval

level

95%

sides

2-sided

lower limit

6.15

upper limit

11.29

Notes
[15] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

Primary: Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort

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End point title

Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort

End point description

Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort subjects with adequate blood volume. In the Non-13vPnC cohort, a sample of subjects with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution. Analysis population for this endpoint included all subjects who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of subjects analyzed indicates the total number of subjects in this analysis population.

End point type

Primary

End point timeframe

Day 1

End point values	13vPnC Cohort	Non-13vPnC Cohort
Number of subjects analysed	92 ^[16]	184 ^[17]
Units: Titers
geometric mean (confidence interval 95%)
Serotype: 1 (n=61,69)	70.9 (40.8 to 123.3)	14.8 (9.2 to 24.0)
Serotype: 3 (n=61,69)	272.8 (173.9 to 428.0)	30.1 (18.7 to 48.4)
Serotype: 4 (n=61,69)	1148.4 (755.0 to 1746.6)	79.9 (38.6 to 165.3)
Serotype: 5 (n=61,69)	326.5 (197.8 to 538.8)	18.1 (10.8 to 30.2)
Serotype: 6A (n=61,69)	1825.9 (1077.4 to 3094.4)	53.9 (27.0 to 107.4)
Serotype: 6B (n=61,69)	844.8 (489.7 to 1457.4)	60.1 (31.9 to 113.4)
Serotype: 7F (n=61,69)	3791.4 (2495.7 to 5759.6)	223.2 (115.8 to 430.2)
Serotype: 9V (n=61,69)	919.7 (559.9 to 1510.6)	47.6 (27.2 to 83.3)
Serotype: 14 (n=61,69)	1387.9 (921.8 to 2089.8)	132.7 (66.9 to 263.1)
Serotype: 18C (n=61,69)	404.2 (255.9 to 638.5)	33.3 (19.6 to 56.7)
Serotype: 19A (n=61,69)	1046.6 (620.0 to 1766.6)	44.3 (25.1 to 77.9)
Serotype: 19F (n=61,69)	554.2 (344.6 to 891.3)	31.4 (18.5 to 53.4)
Serotype: 23F (n=61,69)	3634.9 (2281.4 to 5791.3)	81.8 (40.1 to 166.7)

Notes
[16] - Subjects with available data (n=X,X in category titles) were analyzed.
[17] - Subjects with available data (n=X,X in category titles) were analyzed.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[18]

Method

Parameter type

Geometric Mean Ratio (GMR)

Point estimate

4.78

Confidence interval

level

95%

sides

2-sided

lower limit

2.32

upper limit

9.86

Notes
[18] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[19]

Method

Parameter type

GMR

Point estimate

9.06

Confidence interval

level

95%

sides

2-sided

lower limit

4.72

upper limit

17.39

Notes
[19] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[20]

Method

Parameter type

GMR

Point estimate

14.37

Confidence interval

level

95%

sides

2-sided

lower limit

6.25

upper limit

33.05

Notes
[20] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[21]

Method

Parameter type

GMR

Point estimate

18.03

Confidence interval

level

95%

sides

2-sided

lower limit

8.84

upper limit

36.8

Notes
[21] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[22]

Method

Parameter type

GMR

Point estimate

33.88

Confidence interval

level

95%

sides

2-sided

lower limit

14.33

upper limit

80.13

Notes
[22] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[23]

Method

Parameter type

GMR

Point estimate

14.05

Confidence interval

level

95%

sides

2-sided

lower limit

6.07

upper limit

32.52

Notes
[23] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[24]

Method

Parameter type

GMR

Point estimate

16.99

Confidence interval

level

95%

sides

2-sided

lower limit

7.85

upper limit

36.76

Notes
[24] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[25]

Method

Parameter type

GMR

Point estimate

19.31

Confidence interval

level

95%

sides

2-sided

lower limit

9.13

upper limit

40.84

Notes
[25] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[26]

Method

Parameter type

GMR

Point estimate

10.46

Confidence interval

level

95%

sides

2-sided

lower limit

4.74

upper limit

23.1

Notes
[26] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[27]

Method

Parameter type

GMR

Point estimate

12.13

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

24.51

Notes
[27] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[28]

Method

Parameter type

GMR

Point estimate

23.65

Confidence interval

level

95%

sides

2-sided

lower limit

10.94

upper limit

51.1

Notes
[28] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[29]

Method

Parameter type

GMR

Point estimate

17.62

Confidence interval

level

95%

sides

2-sided

lower limit

8.65

upper limit

35.93

Notes
[29] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMT of 13vPnC Cohort)/(GMT of Non-13vPnC Cohort)

Comparison groups

13vPnC Cohort v Non-13vPnC Cohort

Number of subjects included in analysis

276

Analysis specification

Pre-specified

Analysis type

superiority ^[30]

Method

Parameter type

GMR

Point estimate

44.46

Confidence interval

level

95%

sides

2-sided

lower limit

19.11

upper limit

103.43

Notes
[30] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

Primary: GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis

Top of page

End point title

GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis

End point description

Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all subjects with a collected blood sample. For each cohort, subjects were assigned to 2 subgroups: subject in whom a 13vPnC VT strain had been isolated from the respiratory tract, and subject from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Analysis population for this endpoint included all subjects who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of subjects analyzed indicates the total number of subjects in this analysis population.

End point type

Primary

End point timeframe

Day 1

End point values	13vPnC Cohort: VT+ Subgroup	13vPnC Cohort: VT- or Sp- Subgroup	Non-13vPnC Cohort: VT+ Subgroup	Non-13vPnC Cohort: VT- or Sp- Subgroup
Number of subjects analysed	7 ^[31]	79 ^[32]	20 ^[33]	140 ^[34]
Units: μg/mL
geometric mean (confidence interval 95%)
Serotype: 1 (n=7,79,20,136)	0.81 (0.28 to 2.33)	1.69 (1.23 to 2.31)	0.08 (0.04 to 0.18)	0.12 (0.09 to 0.16)
Serotype: 3 (n=7,79,20,140)	0.32 (0.10 to 1.04)	0.44 (0.33 to 0.58)	0.05 (0.03 to 0.09)	0.07 (0.06 to 0.09)
Serotype: 4 (n=7,79,20,140)	0.97 (0.26 to 3.64)	1.43 (1.02 to 2.00)	0.05 (0.02 to 0.11)	0.07 (0.05 to 0.09)
Serotype: 5 (n=7,79,20,140)	1.45 (0.51 to 4.15)	1.77 (1.41 to 2.24)	0.58 (0.40 to 0.83)	0.72 (0.61 to 0.85)
Serotype: 6A (n=7,79,20,140)	1.78 (0.73 to 4.32)	2.59 (1.93 to 3.48)	0.34 (0.22 to 0.51)	0.36 (0.31 to 0.43)
Serotype: 6B (n=7,79,20,140)	1.94 (0.78 to 4.81)	2.60 (1.93 to 3.50)	0.51 (0.31 to 0.84)	0.33 (0.28 to 0.40)
Serotype: 7F (n=7,79,20,139)	0.83 (0.36 to 1.92)	1.97 (1.50 to 2.59)	0.14 (0.07 to 0.29)	0.19 (0.15 to 0.23)
Serotype: 9V (n=7,79,20,140)	0.97 (0.37 to 2.53)	1.21 (0.96 to 1.54)	0.22 (0.10 to 0.46)	0.30 (0.25 to 0.36)
Serotype: 14 (n=7,79,19,138)	3.29 (0.49 to 21.91)	4.96 (3.54 to 6.94)	0.04 (0.02 to 0.09)	0.08 (0.06 to 0.12)
Serotype: 18C (n=7,79,20,138)	0.65 (0.30 to 1.44)	1.08 (0.81 to 1.45)	0.04 (0.02 to 0.09)	0.06 (0.05 to 0.08)
Serotype: 19A (n=7,79,20,140)	4.69 (2.35 to 9.38)	3.02 (2.30 to 3.97)	0.58 (0.37 to 0.90)	0.74 (0.63 to 0.86)
Serotype: 19F (n=7,79,20,138)	5.80 (1.41 to 23.82)	3.22 (2.41 to 4.28)	0.38 (0.21 to 0.68)	0.33 (0.26 to 0.42)
Serotype: 23F (n=7,79,20,140)	1.04 (0.47 to 2.32)	2.23 (1.65 to 3.02)	0.25 (0.15 to 0.40)	0.23 (0.20 to 0.27)

Notes
[31] - Subjects with available data (n=X,X,X,X in category titles) were analyzed.
[32] - Subjects with available data (n=X,X,X,X in category titles) were analyzed.
[33] - Subjects with available data (n=X,X,X,X in category titles) were analyzed.
[34] - Subjects with available data (n=X,X,X,X in category titles) were analyzed.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[35]

Method

Parameter type

Geometric Mean Ratio (GMR)

Point estimate

0.48

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

1.42

Notes
[35] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[36]

Method

Parameter type

GMR

Point estimate

0.74

Confidence interval

level

95%

sides

2-sided

lower limit

0.27

upper limit

1.98

Notes
[36] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[37]

Method

Parameter type

GMR

Point estimate

0.68

Confidence interval

level

95%

sides

2-sided

lower limit

0.21

upper limit

2.19

Notes
[37] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[38]

Method

Parameter type

GMR

Point estimate

0.82

Confidence interval

level

95%

sides

2-sided

lower limit

0.36

upper limit

1.86

Notes
[38] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[39]

Method

Parameter type

GMR

Point estimate

0.68

Confidence interval

level

95%

sides

2-sided

lower limit

0.25

upper limit

1.89

Notes
[39] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[40]

Method

Parameter type

GMR

Point estimate

0.74

Confidence interval

level

95%

sides

2-sided

lower limit

0.27

upper limit

2.07

Notes
[40] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[41]

Method

Parameter type

GMR

Point estimate

0.42

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

1.09

Notes
[41] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[42]

Method

Parameter type

GMR

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.35

upper limit

1.81

Notes
[42] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[43]

Method

Parameter type

GMR

Point estimate

0.66

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

2.24

Notes
[43] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[44]

Method

Parameter type

GMR

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.22

upper limit

1.65

Notes
[44] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[45]

Method

Parameter type

GMR

Point estimate

1.55

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

3.93

Notes
[45] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[46]

Method

Parameter type

GMR

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

4.99

Notes
[46] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[47]

Method

Parameter type

GMR

Point estimate

0.65

Confidence interval

level

95%

sides

2-sided

lower limit

0.31

upper limit

1.38

Notes
[47] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[48]

Method

Parameter type

GMR

Point estimate

0.47

Confidence interval

level

95%

sides

2-sided

lower limit

0.17

upper limit

1.31

Notes
[48] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[49]

Method

Parameter type

GMR

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

1.24

Notes
[49] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[50]

Method

Parameter type

GMR

Point estimate

0.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.33

upper limit

1.59

Notes
[50] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[51]

Method

Parameter type

GMR

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.52

upper limit

1.25

Notes
[51] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[52]

Method

Parameter type

GMR

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.57

upper limit

1.52

Notes
[52] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[53]

Method

Parameter type

GMR

Point estimate

1.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.95

upper limit

2.47

Notes
[53] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[54]

Method

Parameter type

GMR

Point estimate

0.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.34

upper limit

1.57

Notes
[54] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[55]

Method

Parameter type

GMR

Point estimate

0.74

Confidence interval

level

95%

sides

2-sided

lower limit

0.41

upper limit

1.34

Notes
[55] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[56]

Method

Parameter type

GMR

Point estimate

0.44

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

1.18

Notes
[56] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[57]

Method

Parameter type

GMR

Point estimate

0.59

Confidence interval

level

95%

sides

2-sided

lower limit

0.25

upper limit

1.4

Notes
[57] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[58]

Method

Parameter type

GMR

Point estimate

0.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.23

Notes
[58] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[59]

Method

Parameter type

GMR

Point estimate

1.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

2.18

Notes
[59] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMC of VT+ Subgroup)/(GMC of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[60]

Method

Parameter type

GMR

Point estimate

1.08

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

1.72

Notes
[60] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[61]

Method

Parameter type

GMR

Point estimate

6.17

Confidence interval

level

95%

sides

2-sided

lower limit

2.07

upper limit

18.42

Notes
[61] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[62]

Method

Parameter type

GMR

Point estimate

10.3

Confidence interval

level

95%

sides

2-sided

lower limit

2.44

upper limit

43.49

Notes
[62] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[63]

Method

Parameter type

GMR

Point estimate

18.7

Confidence interval

level

95%

sides

2-sided

lower limit

4.35

upper limit

80.37

Notes
[63] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[64]

Method

Parameter type

GMR

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.14

upper limit

5.52

Notes
[64] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[65]

Method

Parameter type

GMR

Point estimate

5.24

Confidence interval

level

95%

sides

2-sided

lower limit

2.33

upper limit

11.8

Notes
[65] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[66]

Method

Parameter type

GMR

Point estimate

3.77

Confidence interval

level

95%

sides

2-sided

lower limit

1.47

upper limit

9.65

Notes
[66] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[67]

Method

Parameter type

GMR

Point estimate

5.94

Confidence interval

level

95%

sides

2-sided

lower limit

1.65

upper limit

21.36

Notes
[67] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[68]

Method

Parameter type

GMR

Point estimate

4.44

Confidence interval

level

95%

sides

2-sided

lower limit

1.17

upper limit

16.87

Notes
[68] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[69]

Method

Parameter type

GMR

Point estimate

90.8

Confidence interval

level

95%

sides

2-sided

lower limit

16.67

upper limit

494.56

Notes
[69] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[70]

Method

Parameter type

GMR

Point estimate

17.83

Confidence interval

level

95%

sides

2-sided

lower limit

3.79

upper limit

83.78

Notes
[70] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[71]

Method

Parameter type

GMR

Point estimate

8.11

Confidence interval

level

95%

sides

2-sided

lower limit

3.6

upper limit

18.3

Notes
[71] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[72]

Method

Parameter type

GMR

Point estimate

15.29

Confidence interval

level

95%

sides

2-sided

lower limit

4.64

upper limit

50.35

Notes
[72] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMC of 13vPnC VT+ Subgroup)/(GMC of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[73]

Method

Parameter type

GMR

Point estimate

4.19

Confidence interval

level

95%

sides

2-sided

lower limit

1.72

upper limit

10.25

Notes
[73] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[74]

Method

Parameter type

GMR

Point estimate

13.93

Confidence interval

level

95%

sides

2-sided

lower limit

9.14

upper limit

21.23

Notes
[74] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[75]

Method

Parameter type

GMR

Point estimate

5.86

Confidence interval

level

95%

sides

2-sided

lower limit

4.17

upper limit

8.24

Notes
[75] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[76]

Method

Parameter type

GMR

Point estimate

19.97

Confidence interval

level

95%

sides

2-sided

lower limit

12.8

upper limit

31.15

Notes
[76] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[77]

Method

Parameter type

GMR

Point estimate

2.46

Confidence interval

level

95%

sides

2-sided

lower limit

1.87

upper limit

3.24

Notes
[77] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[78]

Method

Parameter type

GMR

Point estimate

7.12

Confidence interval

level

95%

sides

2-sided

lower limit

5.05

upper limit

10.03

Notes
[78] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[79]

Method

Parameter type

GMR

Point estimate

7.78

Confidence interval

level

95%

sides

2-sided

lower limit

5.54

upper limit

10.92

Notes
[79] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[80]

Method

Parameter type

GMR

Point estimate

10.4

Confidence interval

level

95%

sides

2-sided

lower limit

7.4

upper limit

14.61

Notes
[80] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[81]

Method

Parameter type

GMR

Point estimate

4.07

Confidence interval

level

95%

sides

2-sided

lower limit

3.04

upper limit

5.47

Notes
[81] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[82]

Method

Parameter type

GMR

Point estimate

60.32

Confidence interval

level

95%

sides

2-sided

lower limit

37.25

upper limit

97.67

Notes
[82] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[83]

Method

Parameter type

GMR

Point estimate

17.35

Confidence interval

level

95%

sides

2-sided

lower limit

11.37

upper limit

26.47

Notes
[83] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[84]

Method

Parameter type

GMR

Point estimate

9.68

Confidence interval

level

95%

sides

2-sided

lower limit

6.65

upper limit

14.08

Notes
[84] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[85]

Method

Parameter type

GMR

Point estimate

4.11

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

5.62

Notes
[85] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMC of 13vPnC VT- or Sp- Subgroup)/(GMC of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[86]

Method

Parameter type

GMR

Point estimate

9.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.9

upper limit

13.64

Notes
[86] - The 2-sided 95% CI on the GMRs (the GMC of 13vPnC Cohort to the GMC of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (IgG) using Student’s t distribution.

Primary: GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis

Top of page

End point title

GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis

End point description

Blood sample (5mL) was collected from peripheral veins within 24 hours of enrollment. Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) were determined in all 13vPnC cohort subjects with adequate blood volume. In the Non-13vPnC cohort, a sample of subjects with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, subjects were assigned to 2 subgroups: subject in whom a 13vPnC VT strain had been isolated from the respiratory tract, and subject from whom a 13vPnC VT strain had not been isolated from the respiratory tract. Titer was expressed as reciprocal of the highest serum dilution. Analysis population included all subjects who signed the ICD, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of subjects analyzed indicates the number of subjects in this analysis population.

End point type

Primary

End point timeframe

Day 1

End point values	13vPnC Cohort: VT+ Subgroup	13vPnC Cohort: VT- or Sp- Subgroup	Non-13vPnC Cohort: VT+ Subgroup	Non-13vPnC Cohort: VT- or Sp- Subgroup
Number of subjects analysed	7	79	20	140
Units: Titers
geometric mean (confidence interval 95%)
Serotype: 1 (n=5,52,9,54)	35.0 (2.2 to 547.7)	71.1 (38.4 to 131.4)	11.1 (4.1 to 30.5)	14.6 (8.4 to 25.4)
Serotype: 3 (n=5,52,9,54)	146.6 (35.6 to 602.7)	273.7 (163.5 to 458.2)	29.2 (14.0 to 61.0)	28.6 (16.3 to 50.1)
Serotype: 4 (n=5,52,9,54)	522.0 (165.0 to 1651.2)	1154.4 (726.1 to 1835.4)	38.1 (6.7 to 216.9)	86.1 (37.4 to 198.3)
Serotype: 5 (n=5,52,9,54)	539.5 (41.4 to 7035.5)	302.7 (173.2 to 529.0)	11.1 (3.6 to 34.7)	17.6 (9.9 to 31.4)
Serotype: 6A (n=5,52,9,54)	482.4 (31.8 to 7306.4)	2110.3 (1176.4 to 3785.6)	46.1 (5.8 to 366.1)	52.5 (23.7 to 116.2)
Serotype: 6B (n=5,52,9,54)	69.4 (1.4 to 3480.8)	1099.1 (639.5 to 1889.0)	102.7 (14.2 to 742.0)	53.9 (26.4 to 110.3)
Serotype: 7F (n=5,52,9,54)	4661.3 (2222.1 to 9777.9)	3837.7 (2367.8 to 6220.2)	442.5 (87.9 to 2228.3)	180.8 (84.0 to 389.4)
Serotype: 9V (n=5,52,9,54)	215.9 (6.7 to 6985.7)	1074.9 (637.7 to 1811.9)	65.0 (13.3 to 318.0)	45.3 (23.7 to 86.6)
Serotype: 14 (n=5,52,9,54)	578.9 (89.2 to 3755.8)	1617.3 (1046.6 to 2499.2)	289.1 (22.7 to 3682.3)	125.9 (59.7 to 265.4)
Serotype: 18C (n=5,52,9,54)	364.1 (83.5 to 1587.8)	443.2 (265.2 to 740.7)	22.3 (5.3 to 93.2)	34.4 (19.2 to 61.8)
Serotype: 19A (n=5,52,9,54)	1515.6 (296.4 to 7750.1)	1122.7 (622.0 to 2026.5)	62.7 (8.6 to 456.6)	41.6 (22.1 to 78.3)
Serotype: 19F (n=5,52,9,54)	1830.0 (240.5 to 13924.9)	472.7 (279.4 to 799.7)	19.3 (5.5 to 67.5)	30.4 (16.6 to 55.7)
Serotype: 23F (n=5,52,9,54)	1092.5 (140.0 to 8523.4)	4111.0 (2442.0 to 6920.7)	104.1 (14.5 to 746.9)	84.4 (37.3 to 190.9)

GMR for Serotype: 1

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[87]

Method

Parameter type

GMR

Point estimate

0.49

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

3.91

Notes
[87] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[88]

Method

Parameter type

GMR

Point estimate

0.54

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

2.92

Notes
[88] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[89]

Method

Parameter type

GMR

Point estimate

0.45

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

2.07

Notes
[89] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[90]

Method

Parameter type

GMR

Point estimate

1.78

Confidence interval

level

95%

sides

2-sided

lower limit

0.27

upper limit

11.75

Notes
[90] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[91]

Method

Parameter type

GMR

Point estimate

0.23

Confidence interval

level

95%

sides

2-sided

lower limit

0.03

upper limit

1.65

Notes
[91] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[92]

Method

Parameter type

GMR

Point estimate

0.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.01

upper limit

0.44

Notes
[92] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[93]

Method

Parameter type

GMR

Point estimate

0.36

Confidence interval

level

95%

sides

2-sided

lower limit

0.08

upper limit

1.55

Notes
[93] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[94]

Method

Parameter type

GMR

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.03

upper limit

1.26

Notes
[94] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[95]

Method

Parameter type

GMR

Point estimate

1.21

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

2.65

Notes
[95] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[96]

Method

Parameter type

GMR

Point estimate

0.82

Confidence interval

level

95%

sides

2-sided

lower limit

0.15

upper limit

4.47

Notes
[96] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[97]

Method

Parameter type

GMR

Point estimate

1.35

Confidence interval

level

95%

sides

2-sided

lower limit

0.19

upper limit

9.44

Notes
[97] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[98]

Method

Parameter type

GMR

Point estimate

3.87

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

22.42

Notes
[98] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v 13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[99]

Method

Parameter type

GMR

Point estimate

0.27

Confidence interval

level

95%

sides

2-sided

lower limit

0.05

upper limit

1.52

Notes
[99] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[100]

Method

Parameter type

GMR

Point estimate

1.02

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

2.46

Notes
[100] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[101]

Method

Parameter type

GMR

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

0.19

upper limit

3.07

Notes
[101] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[102]

Method

Parameter type

GMR

Point estimate

0.44

Confidence interval

level

95%

sides

2-sided

lower limit

0.05

upper limit

3.73

Notes
[102] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[103]

Method

Parameter type

GMR

Point estimate

0.44

Confidence interval

level

95%

sides

2-sided

lower limit

0.05

upper limit

3.73

Notes
[103] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[104]

Method

Parameter type

GMR

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.15

upper limit

2.73

Notes
[104] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[105]

Method

Parameter type

GMR

Point estimate

0.88

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

6.99

Notes
[105] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[106]

Method

Parameter type

GMR

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.29

upper limit

12.51

Notes
[106] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[107]

Method

Parameter type

GMR

Point estimate

1.43

Confidence interval

level

95%

sides

2-sided

lower limit

0.27

upper limit

7.7

Notes
[107] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[108]

Method

Parameter type

GMR

Point estimate

2.45

Confidence interval

level

95%

sides

2-sided

lower limit

0.34

upper limit

17.43

Notes
[108] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[109]

Method

Parameter type

GMR

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

17.41

Notes
[109] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[110]

Method

Parameter type

GMR

Point estimate

0.65

Confidence interval

level

95%

sides

2-sided

lower limit

0.14

upper limit

2.97

Notes
[110] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[111]

Method

Parameter type

GMR

Point estimate

1.51

Confidence interval

level

95%

sides

2-sided

lower limit

0.28

upper limit

8.21

Notes
[111] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[112]

Method

Parameter type

GMR

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.13

upper limit

2.97

Notes
[112] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMT of VT+ Subgroup)/(GMT of VT- or Sp- Subgroup)

Comparison groups

Non-13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

160

Analysis specification

Pre-specified

Analysis type

superiority ^[113]

Method

Parameter type

GMR

Point estimate

1.23

Confidence interval

level

95%

sides

2-sided

lower limit

0.15

upper limit

10.24

Notes
[113] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[114]

Method

Parameter type

GMR

Point estimate

5.02

Confidence interval

level

95%

sides

2-sided

lower limit

1.45

upper limit

17.39

Notes
[114] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[115]

Method

Parameter type

GMR

Point estimate

3.15

Confidence interval

level

95%

sides

2-sided

lower limit

0.41

upper limit

23.91

Notes
[115] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[116]

Method

Parameter type

GMR

Point estimate

13.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.32

upper limit

141.81

Notes
[116] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[117]

Method

Parameter type

GMR

Point estimate

48.41

Confidence interval

level

95%

sides

2-sided

lower limit

6.16

upper limit

380.54

Notes
[117] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[118]

Method

Parameter type

GMR

Point estimate

10.47

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

229.1

Notes
[118] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[119]

Method

Parameter type

GMR

Point estimate

0.68

Confidence interval

level

95%

sides

2-sided

lower limit

0.02

upper limit

19.83

Notes
[119] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[120]

Method

Parameter type

GMR

Point estimate

10.53

Confidence interval

level

95%

sides

2-sided

lower limit

1.98

upper limit

55.96

Notes
[120] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[121]

Method

Parameter type

GMR

Point estimate

3.32

Confidence interval

level

95%

sides

2-sided

lower limit

0.19

upper limit

56.82

Notes
[121] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[122]

Method

Parameter type

GMR

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

63.12

Notes
[122] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[123]

Method

Parameter type

GMR

Point estimate

16.31

Confidence interval

level

95%

sides

2-sided

lower limit

2.15

upper limit

123.48

Notes
[123] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[124]

Method

Parameter type

GMR

Point estimate

24.16

Confidence interval

level

95%

sides

2-sided

lower limit

1.59

upper limit

367.81

Notes
[124] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[125]

Method

Parameter type

GMR

Point estimate

95.06

Confidence interval

level

95%

sides

2-sided

lower limit

13.08

upper limit

691.01

Notes
[125] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMT of 13vPnC VT+ Subgroup)/(GMT of non-13vPnC VT+ Subgroup)

Comparison groups

13vPnC Cohort: VT+ Subgroup v Non-13vPnC Cohort: VT+ Subgroup

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority ^[126]

Method

Parameter type

GMR

Point estimate

10.49

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

171.84

Notes
[126] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 1

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[127]

Method

Parameter type

GMR

Point estimate

4.86

Confidence interval

level

95%

sides

2-sided

lower limit

2.15

upper limit

10.96

Notes
[127] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 3

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[128]

Method

Parameter type

GMR

Point estimate

9.57

Confidence interval

level

95%

sides

2-sided

lower limit

4.5

upper limit

20.36

Notes
[128] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 5

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[129]

Method

Parameter type

GMR

Point estimate

17.15

Confidence interval

level

95%

sides

2-sided

lower limit

7.76

upper limit

37.91

Notes
[129] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 4

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[130]

Method

Parameter type

GMR

Point estimate

13.4

Confidence interval

level

95%

sides

2-sided

lower limit

5.2

upper limit

34.51

Notes
[130] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6A

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[131]

Method

Parameter type

GMR

Point estimate

40.2

Confidence interval

level

95%

sides

2-sided

lower limit

15.16

upper limit

106.65

Notes
[131] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 7F

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[132]

Method

Parameter type

GMR

Point estimate

21.22

Confidence interval

level

95%

sides

2-sided

lower limit

8.65

upper limit

52.07

Notes
[132] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 6B

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[133]

Method

Parameter type

GMR

Point estimate

20.38

Confidence interval

level

95%

sides

2-sided

lower limit

8.39

upper limit

49.51

Notes
[133] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 9V

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[134]

Method

Parameter type

GMR

Point estimate

23.73

Confidence interval

level

95%

sides

2-sided

lower limit

10.39

upper limit

54.19

Notes
[134] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 14

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[135]

Method

Parameter type

GMR

Point estimate

12.84

Confidence interval

level

95%

sides

2-sided

lower limit

5.46

upper limit

30.22

Notes
[135] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 18C

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[136]

Method

Parameter type

GMR

Point estimate

12.88

Confidence interval

level

95%

sides

2-sided

lower limit

5.95

upper limit

27.88

Notes
[136] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19F

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[137]

Method

Parameter type

GMR

Point estimate

15.53

Confidence interval

level

95%

sides

2-sided

lower limit

7.02

upper limit

34.38

Notes
[137] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 19A

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[138]

Method

Parameter type

GMR

Point estimate

26.99

Confidence interval

level

95%

sides

2-sided

lower limit

11.46

upper limit

63.58

Notes
[138] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

GMR for Serotype: 23F

Statistical analysis description

GMR=(GMT of 13vPnC VT- or Sp- Subgroup)/(GMT of non-13vPnC VT- or Sp- Subgroup)

Comparison groups

13vPnC Cohort: VT- or Sp- Subgroup v Non-13vPnC Cohort: VT- or Sp- Subgroup

Number of subjects included in analysis

219

Analysis specification

Pre-specified

Analysis type

superiority ^[139]

Method

Parameter type

GMR

Point estimate

48.73

Confidence interval

level

95%

sides

2-sided

lower limit

18.67

upper limit

127.16

Notes
[139] - The 2-sided 95% CI on the GMRs (the GMT of 13vPnC Cohort to the GMT of Non-13vPnC Cohort) for all 13 serotypes are provided and those 95% CIs were constructed by back transformation of the CIs for the mean difference of the measures on the logarithmically transformed scale (MOPA) using Student’s t distribution.

Adverse events

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Timeframe for reporting adverse events

From the time of the blood draw or aspirate collection through and including 12 hours on Day 1

Adverse event reporting additional description

Each AE was to be assessed to determine if it met the criteria for SAEs. If an SAE occurred, expedited reporting followed local and international regulations, as appropriate.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

Non-13vPnC Cohort

Reporting group description

The vaccination history of 13vPnC initially was obtained either from the subject's parent/caregiver; confirmation of 13vPnC receipt from vaccine book or image of vaccine book was required. If 13vPnC vaccination was confirmed as not received, and all other inclusion / exclusion criteria were met, this subject might be enrolled and assigned to the unvaccinated group. No vaccines administered during the study.

Reporting group title

13vPnC Cohort

Reporting group description

Serious adverse events	Non-13vPnC Cohort	13vPnC Cohort
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 199 (0.00%)	0 / 101 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events

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

Non-serious adverse events	Non-13vPnC Cohort	13vPnC Cohort
Total subjects affected by non serious adverse events
subjects affected / exposed	0 / 199 (0.00%)	0 / 101 (0.00%)

Notes
[1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
Justification: There were no non-serious adverse events reported in >=5% subjects in this study.

More information

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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

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Clinical trials

Clinical Trial Results:
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

Trial information

Trial information

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Baseline characteristics

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End points

Primary: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort

Primary: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort

Primary: Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort

Primary: Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort

Primary: GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis

Primary: GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis

Primary: GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis

Primary: GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis

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Adverse events

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Substantial protocol amendments (globally)

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Clinical trials

Clinical Trial Results: A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort

Primary: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort

Primary: Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort

Primary: Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort

Primary: GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis

Primary: GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis

Primary: GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis

Primary: GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS