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Clinical Trial Results:
A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine

Summary
EudraCT number	2009-015321-37
Trial protocol	FR
Global end of trial date	17 Nov 2010

Results information
Results version number	v1(current)
This version publication date	29 Jun 2016
First version publication date	01 Aug 2015
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

6096A1-3021FR

ISRCTN number

US NCT number

NCT01026038

WHO universal trial number (UTN)

Other trial identifiers

Alias: B1851016

Sponsor organisation name

Pfizer Inc.

Sponsor organisation address

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

Public contact

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

Scientific contact

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

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

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

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

Yes

Analysis stage

Final

Date of interim/final analysis

25 May 2011

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Nov 2010

Was the trial ended prematurely?

Main objective of the trial

To evaluate the antibody levels to the 13 pneumococcal vaccine serotypes not earlier than 24 months and the immune response to 13-valent pneumococcal conjugate vaccine(13vPnC) serotypes 1 month after a dose of 13vPnC administered not earlier than 24 months after the toddler dose in study 6096A1-008-EU, as measured by serotype specific immunoglobulin G (IgG) concentrations.

Protection of trial subjects

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

Background therapy

Evidence for comparator

Actual start date of recruitment

12 Apr 2010

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 262

Worldwide total number of subjects

262

EEA total number of subjects

262

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

262

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

A total of 263 subjects who had received a 4-dose vaccination series of pneumococcal conjugate vaccine as part of study 6096A1-008 (NCT00366678) were enrolled for this study. Out of those 1 subject was a screen failure and was not included in results.

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/13vPnC/13vPnC

Arm description

Single dose of 13vPnC, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.

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

Single dose (0.5 milliliter [mL]) of 13vPnC vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.

7vPnC/7vPnC/13vPnC

Arm description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.

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

Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/7vPnC vaccine.

7vPnC/13vPnC/13vPnC

Arm description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule of (3 infant doses/1 toddler dose) 7vPnC/13vPnC vaccine.

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

Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.

Number of subjects in period 1	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Started	130	65	67
Completed	129	64	67
Not completed	1	1	0
Lost to follow-up	1	1	-

Baseline characteristics

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Reporting group title

13vPnC/13vPnC/13vPnC

Reporting group description

Single dose of 13vPnC, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.

Reporting group title

7vPnC/7vPnC/13vPnC

Reporting group description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.

Reporting group title

7vPnC/13vPnC/13vPnC

Reporting group description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule of (3 infant doses/1 toddler dose) 7vPnC/13vPnC vaccine.

Reporting group values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC	Total
Number of subjects	130	65	67	262
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	3.4 ( 0.25 )	3.4 ( 0.24 )	3.5 ( 0.25 )	-
Gender categorical
Units: Subjects
Female	70	29	40	139
Male	60	36	27	123

End points

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Reporting group title

13vPnC/13vPnC/13vPnC

Reporting group description

Single dose of 13vPnC, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.

Reporting group title

7vPnC/7vPnC/13vPnC

Reporting group description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.

Reporting group title

7vPnC/13vPnC/13vPnC

Reporting group description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule of (3 infant doses/1 toddler dose) 7vPnC/13vPnC vaccine.

Primary: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine

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End point title

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine

End point description

Antibody GMC as measured by microgram per millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all subjects with available data for the specified blood draw. Evaluable immunogenicity population: eligible subjects, randomised, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations.

End point type

Primary

End point timeframe

One month after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	120 ^[1]	57 ^[2]	58 ^[3]
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 4	10.34 (8.94 to 11.97)	12.79 (10 to 16.35)	8.98 (6.98 to 11.56)
Serotype 6B	31.62 (27.02 to 37.01)	51.07 (38.65 to 67.49)	35.38 (27.25 to 45.93)
Serotype 9V	6.76 (5.9 to 7.73)	6.5 (5.31 to 7.95)	6.19 (5.04 to 7.61)
Serotype 14	21.55 (18.41 to 25.24)	21.15 (16.89 to 26.48)	20.73 (16.45 to 26.12)
Serotype 18C	4.56 (3.93 to 5.29)	6.12 (4.89 to 7.65)	5.35 (4.27 to 6.71)
Serotype 19F	16.59 (13.57 to 20.28)	12.07 (9.35 to 15.59)	15.09 (11.17 to 20.39)
Serotype 23F	8.68 (7.5 to 10.03)	10.87 (8.3 to 14.22)	9.1 (7.34 to 11.28)
Serotype 1	10.72 (9.17 to 12.52)	2.96 (2.45 to 3.59)	20.69 (16.14 to 26.53)
Serotype 3	1.81 (1.46 to 2.23)	1.6 (1.19 to 2.17)	2.07 (1.66 to 2.59)
Serotype 5	10 (8.63 to 11.58)	2.86 (2.37 to 3.46)	19.2 (14.93 to 24.7)
Serotype 6A	23.09 (19.5 to 27.33)	14.38 (10.53 to 19.64)	18.6 (13.87 to 24.93)
Serotype 7F	8.23 (7.11 to 9.52)	5.04 (4.16 to 6.11)	8.02 (6.66 to 9.67)
Serotype 19A	17.1 (14.54 to 20.11)	8.58 (6.7 to 10.99)	16.46 (13.42 to 20.19)

Notes
[1] - N= number of subjects with determinate IgG antibody concentration to serotype.
[2] - N= number of subjects with determinate IgG antibody concentration to serotype.
[3] - N= number of subjects with determinate IgG antibody concentration to serotype

4: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.07

4: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.15

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.52

4: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.42

Confidence interval

level

95%

sides

2-sided

lower limit

1.03

upper limit

1.96

6B: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.62

Confidence interval

level

95%

sides

2-sided

lower limit

0.46

upper limit

0.84

6B: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

1.2

6B: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.44

Confidence interval

level

95%

sides

2-sided

lower limit

1.02

upper limit

2.04

9V: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1.32

9V: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.09

Confidence interval

level

95%

sides

2-sided

lower limit

0.86

upper limit

1.39

9V: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.05

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.39

14: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.02

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

1.34

14: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.37

14: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.02

Confidence interval

level

95%

sides

2-sided

lower limit

0.74

upper limit

1.4

18C: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.57

upper limit

0.97

18C: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.85

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

1.11

18C: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMCratio

Point estimate

1.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.56

19F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.37

Confidence interval

level

95%

sides

2-sided

lower limit

0.97

upper limit

1.94

19F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.78

upper limit

1.55

19F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

1.19

23F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.05

23F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.95

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

1.25

23F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.19

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.64

1: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

3.62

Confidence interval

level

95%

sides

2-sided

lower limit

2.76

upper limit

4.74

1: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.68

1: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.2

3: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.13

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

1.59

3: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.87

Confidence interval

level

95%

sides

2-sided

lower limit

0.62

upper limit

1.23

3: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

0.52

upper limit

1.15

5: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

3.49

Confidence interval

level

95%

sides

2-sided

lower limit

2.68

upper limit

4.54

5: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.68

5: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.15

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

0.2

6A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.61

Confidence interval

level

95%

sides

2-sided

lower limit

1.15

upper limit

2.23

6A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.24

Confidence interval

level

95%

sides

2-sided

lower limit

0.89

upper limit

1.72

6A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

0.53

upper limit

1.13

7F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.63

Confidence interval

level

95%

sides

2-sided

lower limit

1.28

upper limit

2.08

7F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.03

Confidence interval

level

95%

sides

2-sided

lower limit

0.81

upper limit

1.3

7F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.47

upper limit

0.83

19A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.99

Confidence interval

level

95%

sides

2-sided

lower limit

1.51

upper limit

2.63

19A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.37

19A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.52

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

0.72

Primary: Percentage of Subjects with Prespecified Local Reactions

Top of page

End point title

Percentage of Subjects with Prespecified Local Reactions

End point description

Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 centimeter (cm). Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (greator than (>)7.0 cm; >14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Subjects may be reported in more than 1 category. Safety population: all subjects who received the single dose of 13vPnC vaccination. n = number of subjects reporting yes for at least 1 day or no for all days, for each group, respectively.

End point type

Primary

End point timeframe

Seven days after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	130	64	64
Units: percentage of subjects
number (not applicable)
Pain: Any (n= 112, 52, 53)	55.4	55.8	64.2
Pain: Mild (n= 109, 51, 51)	50.5	49	56.9
Pain: Moderate (n= 95, 47, 48)	17.9	25.5	20.8
Pain: Severe (n= 90, 43, 45)	1.1	2.3	2.2
Swelling: Any (101, 48, 47)	39.6	41.7	27.7
Swelling: Mild (n= 96, 48, 47)	28.1	35.4	23.4
Swelling: Moderate (n= 97, 44, 46)	24.7	20.5	10.9
Swelling: Severe (n= 90, 43, 45)	0	2.3	0
Redness: Any (n= 105, 50, 50)	48.6	54	46
Redness: Mild (n= 101, 49, 48)	38.6	40.8	37.5
Redness: Moderate (n= 95, 45, 47)	22.1	31.1	17
Redness: Severe (n= 90, 43, 45)	0	2.3	0

Pain (Any)

Statistical analysis description

Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Pain (Any)

Statistical analysis description

Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.429

Method

Fisher exact

Confidence interval

Pain (Any)

Statistical analysis description

Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.314

Method

Fisher exact

Confidence interval

Pain (Mild)

Statistical analysis description

Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Pain (Mild)

Statistical analysis description

Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.552

Method

Fisher exact

Confidence interval

Pain (Mild)

Statistical analysis description

Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.499

Method

Fisher exact

Confidence interval

Pain (Moderate)

Statistical analysis description

Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.376

Method

Fisher exact

Confidence interval

Pain (Moderate)

Statistical analysis description

Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.633

Method

Fisher exact

Confidence interval

Pain (Moderate)

Statistical analysis description

Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.658

Method

Fisher exact

Confidence interval

Pain (Severe)

Statistical analysis description

Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.544

Method

Fisher exact

Confidence interval

Pain (Severe)

Statistical analysis description

Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Pain (Severe)

Statistical analysis description

Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Swelling (Any)

Statistical analysis description

Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.859

Method

Fisher exact

Confidence interval

Swelling (Any)

Statistical analysis description

Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.197

Method

Fisher exact

Confidence interval

Swelling (Any)

Statistical analysis description

Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.198

Method

Fisher exact

Confidence interval

Swelling (Mild)

Statistical analysis description

Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.443

Method

Fisher exact

Confidence interval

Swelling (Mild)

Statistical analysis description

Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.261

Method

Fisher exact

Confidence interval

Swelling (Mild)

Statistical analysis description

Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.687

Method

Fisher exact

Confidence interval

Swelling (Moderate)

Statistical analysis description

Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.671

Method

Fisher exact

Confidence interval

Swelling (Moderate)

Statistical analysis description

Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.253

Method

Fisher exact

Confidence interval

Swelling (Moderate)

Statistical analysis description

Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.074

Method

Fisher exact

Confidence interval

Swelling (Severe)

Statistical analysis description

Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.323

Method

Fisher exact

Confidence interval

Swelling (Severe)

Statistical analysis description

Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.489

Method

Fisher exact

Confidence interval

Redness (Any)

Statistical analysis description

Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.607

Method

Fisher exact

Confidence interval

Redness (Any)

Statistical analysis description

Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.549

Method

Fisher exact

Confidence interval

Redness (Any)

Statistical analysis description

Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.864

Method

Fisher exact

Confidence interval

Redness (Mild)

Statistical analysis description

Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.859

Method

Fisher exact

Confidence interval

Redness (Mild)

Statistical analysis description

Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.836

Method

Fisher exact

Confidence interval

Redness (Mild)

Statistical analysis description

Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Redness (Moderate)

Statistical analysis description

Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.297

Method

Fisher exact

Confidence interval

Redness (Moderate)

Statistical analysis description

Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.145

Method

Fisher exact

Confidence interval

Redness (Moderate)

Statistical analysis description

Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.517

Method

Fisher exact

Confidence interval

Redness (Severe)

Statistical analysis description

Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.323

Method

Fisher exact

Confidence interval

Redness (Severe)

Statistical analysis description

Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.489

Method

Fisher exact

Confidence interval

Primary: Percentage of Subjects With Prespecified Systemic Events

Top of page

End point title

Percentage of Subjects With Prespecified Systemic Events

End point description

Systemic events (any fever greater than or equals to [>=]38 degree celsius [C], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as >=38 to less than or equals to (<=)39 degree C; >39 to <=40 degree C; >40 degree C. Vomiting: mild (1-2 times/day ); moderate (>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Subjects may be reported in more than 1 category. Safety population: all subjects who received the single dose of 13vPnC vaccination. n = number of subjects reporting yes for at least 1 day or no for all days, for each group, respectively.

End point type

Primary

End point timeframe

Seven days after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	130	64	64
Units: percentage of subjects
number (not applicable)
Fever >=38 to <=39 degree C (n= 93, 49, 46)	15.1	28.6	19.6
Fever >39 to <=40 degree C (n= 92, 43, 46)	2.2	4.7	2.2
Fever >40 degree C (n= 90, 43, 45)	0	0	2.2
Vomiting: Any (n= 91, 44, 45)	3.3	9.1	6.7
Vomiting: Mild (n= 91, 44, 45)	3.3	9.1	6.7
Vomiting: Moderate (n= 90, 43, 45)	0	0	0
Vomiting: Severe (n= 90, 43, 45)	0	0	0
Diarrhea: Any (n= 90, 45, 47)	8.9	17.8	8.5
Diarrhea: Mild (n= 90, 45, 47)	8.9	17.8	8.5
Diarrhea: Moderate (n= 90, 43, 45)	1.1	0	0
Diarrhea: Severe (n= 90, 43, 45)	0	0	0
Fatigue: Any (n= 103, 54, 48)	40.8	51.9	31.3
Fatigue: Mild (n= 100, 49, 48)	34	34.7	20.8
Fatigue: Moderate (n= 96, 49, 46)	16.7	30.6	15.2
Fatigue: Severe (n= 92, 43, 45)	3.3	2.3	2.2

Fever (>=38 degree C to <=39 degree C)

Statistical analysis description

Fever (>=38 degree C to <=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.075

Method

Fisher exact

Confidence interval

Fever (>=38 degree C to <=39 degree C)

Statistical analysis description

Fever (>=38 degree C to <=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC

Comparison groups

7vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.345

Method

Fisher exact

Confidence interval

Fever (>=38 degree C to <=39 degree C)

Statistical analysis description

Fever (>=38 degree C to <=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.628

Method

Fisher exact

Confidence interval

Fever (>=39 degree C to <=40 degree C)

Statistical analysis description

Fever (>=39 degree C to <=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.592

Method

Fisher exact

Confidence interval

Fever (>=39 degree C to <=40 degree C)

Statistical analysis description

Fever (>=39 degree C to <=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.608

Method

Fisher exact

Confidence interval

Fever (>=39 degree C to <=40 degree C)

Statistical analysis description

Fever (>=39 degree C to <=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Fever (>40 degree C)

Statistical analysis description

Fever (>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Fever (>40 degree C)

Statistical analysis description

Fever (>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.333

Method

Fisher exact

Confidence interval

Vomiting (Any)

Statistical analysis description

Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.215

Method

Fisher exact

Confidence interval

Vomiting (Any)

Statistical analysis description

Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.714

Method

Fisher exact

Confidence interval

Vomiting (Any)

Statistical analysis description

Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.397

Method

Fisher exact

Confidence interval

Vomiting (Mild)

Statistical analysis description

Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.215

Method

Fisher exact

Confidence interval

Vomiting (Mild)

Statistical analysis description

Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.714

Method

Fisher exact

Confidence interval

Vomiting (Mild)

Statistical analysis description

Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.397

Method

Fisher exact

Confidence interval

Diarrhea (Any)

Statistical analysis description

Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.161

Method

Fisher exact

Confidence interval

Diarrhea (Any)

Statistical analysis description

Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.226

Method

Fisher exact

Confidence interval

Diarrhea (Any)

Statistical analysis description

Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Diarrhea (Mild)

Statistical analysis description

Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.161

Method

Fisher exact

Confidence interval

Diarrhea (Mild)

Statistical analysis description

Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.226

Method

Fisher exact

Confidence interval

Diarrhea (Mild)

Statistical analysis description

Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Diarrhea (Moderate)

Statistical analysis description

Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Diarrhea (Moderate)

Statistical analysis description

Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Fatigue (Any)

Statistical analysis description

Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.237

Method

Fisher exact

Confidence interval

Fatigue (Any)

Statistical analysis description

Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.045

Method

Fisher exact

Confidence interval

Fatigue (Any)

Statistical analysis description

Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.285

Method

Fisher exact

Confidence interval

Fatigue (Mild)

Statistical analysis description

Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Fatigue (Mild)

Statistical analysis description

Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.174

Method

Fisher exact

Confidence interval

Fatigue (Mild)

Statistical analysis description

Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.125

Method

Fisher exact

Confidence interval

Fatigue (Moderate)

Statistical analysis description

Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.058

Method

Fisher exact

Confidence interval

Fatigue (Moderate)

Statistical analysis description

Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.092

Method

Fisher exact

Confidence interval

Fatigue (Moderate)

Statistical analysis description

Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Fatigue (Severe)

Statistical analysis description

Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Fatigue (Severe)

Statistical analysis description

Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

128

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Fatigue (Severe)

Statistical analysis description

Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

194

Analysis specification

Pre-specified

Analysis type

superiority

P-value

> 0.99

Method

Fisher exact

Confidence interval

Secondary: Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine

Top of page

End point title

Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine

End point description

IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the subjects using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population: eligible subjects, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations.

End point type

Secondary

End point timeframe

Up to 7 days before vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	120 ^[4]	57 ^[5]	58 ^[6]
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 4	0.17 (0.15 to 0.21)	0.23 (1.43 to 3.11)	0.18 (0.15 to 0.22)
Serotype 6B	2.86 (2.35 to 3.48)	4.1 (1.19 to 2.05)	3.21 (2.37 to 4.36)
Serotype 9V	0.72 (0.6 to 0.85)	0.92 (0.09 to 0.2)	0.71 (0.58 to 0.87)
Serotype 14	0.77 (0.61 to 0.98)	0.74 (0.29 to 0.75)	0.59 (0.42 to 0.83)
Serotype 18C	0.21 (0.17 to 0.25)	0.36 (0.89 to 1.41)	0.23 (0.18 to 0.28)
Serotype 19F	2.22 (1.67 to 2.95)	2.11 (1.5 to 2.38)	1.44 (1.04 to 2.02)
Serotype 23F	1.26 (1 to 1.58)	1.56 (0.15 to 0.3)	1.18 (0.92 to 1.52)
Serotype 1	0.35 (0.29 to 0.43)	0.14 (2.6 to 4.41)	0.28 (0.23 to 0.34)
Serotype 3	0.5 (0.35 to 0.71)	0.47 (0.18 to 0.3)	0.42 (0.3 to 0.58)
Serotype 5	1.28 (1.07 to 1.53)	1.12 (2.96 to 5.68)	1.41 (1.19 to 1.67)
Serotype 6A	4.05 (3.25 to 5.04)	1.89 (0.72 to 1.17)	2.47 (1.91 to 3.21)
Serotype 7F	0.65 (0.55 to 0.78)	0.21 (0.52 to 1.06)	0.77 (0.62 to 0.96)
Serotype 19A	6.16 (4.88 to 7.79)	3.38 (0.28 to 0.47)	4.63 (3.43 to 6.26)

Notes
[4] - N= number of subjects with determinate IgG antibody concentration to serotype.
[5] - N= number of subjects with determinate IgG antibody concentration to serotype.
[6] - N= number of subjects with determinate IgG antibody concentration to serotype.

4: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.75

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

4: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

1.28

4: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.29

Confidence interval

level

95%

sides

2-sided

lower limit

0.92

upper limit

1.79

6B: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

6B: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.89

Confidence interval

level

95%

sides

2-sided

lower limit

0.62

upper limit

1.27

6B: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.27

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.94

9V: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.78

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

1.03

9V: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.01

Confidence interval

level

95%

sides

2-sided

lower limit

0.76

upper limit

1.33

9V: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.29

Confidence interval

level

95%

sides

2-sided

lower limit

0.93

upper limit

1.8

14: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.69

upper limit

1.58

14: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.86

upper limit

1.97

14: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.25

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

2.03

18C: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.58

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

0.78

18C: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

1.23

18C: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.58

Confidence interval

level

95%

sides

2-sided

lower limit

1.11

upper limit

2.25

19F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.05

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

1.68

19F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.54

Confidence interval

level

95%

sides

2-sided

lower limit

0.97

upper limit

2.44

19F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.46

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

2.51

23F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

1.15

23F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.74

upper limit

1.52

23F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.32

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

2.01

1: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

2.59

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

3.73

1: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.26

Confidence interval

level

95%

sides

2-sided

lower limit

0.88

upper limit

1.79

1: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.49

Confidence interval

level

95%

sides

2-sided

lower limit

0.32

upper limit

0.74

3: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.87

3: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.19

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

2.09

3: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.12

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

2.15

5: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.15

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.52

5: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.91

Confidence interval

level

95%

sides

2-sided

lower limit

0.69

upper limit

1.2

5: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.79

Confidence interval

level

95%

sides

2-sided

lower limit

0.57

upper limit

1.1

6A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

2.14

Confidence interval

level

95%

sides

2-sided

lower limit

1.52

upper limit

3.02

6A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.64

Confidence interval

level

95%

sides

2-sided

lower limit

1.16

upper limit

2.3

6A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.76

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

1.14

7F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

3.11

Confidence interval

level

95%

sides

2-sided

lower limit

2.23

upper limit

4.33

7F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.84

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.17

7F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.27

Confidence interval

level

95%

sides

2-sided

lower limit

0.19

upper limit

0.4

19A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.82

Confidence interval

level

95%

sides

2-sided

lower limit

1.25

upper limit

2.66

19A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.33

Confidence interval

level

95%

sides

2-sided

lower limit

0.91

upper limit

1.94

19A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.73

Confidence interval

level

95%

sides

2-sided

lower limit

0.47

upper limit

1.13

Secondary: Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine

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End point title

Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine

End point description

IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the subjects using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. Evaluable immunogenicity population: eligible subjects, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations.

End point type

Secondary

End point timeframe

Four to seven days after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	44 ^[7]	18 ^[8]	22 ^[9]
Units: mcg/mL
geometric mean (confidence interval 95%)
Serotype 4	2.96 (1.67 to 5.24)	4.66 (2.01 to 10.82)	3.85 (3.5 to 11.26)
Serotype 6B	17.78 (12.5 to 25.3)	19.15 (8.84 to 41.48)	16.26 (3.51 to 18.23)
Serotype 9V	3.49 (2.39 to 5.09)	3.15 (1.75 to 5.66)	3.2 (0.94 to 1.72)
Serotype 14	5.55 (3.32 to 9.3)	5.67 (2.29 to 13.99)	4.52 (5.29 to 18.19)
Serotype 18C	2.31 (1.36 to 3.91)	3.34 (1.66 to 6.72)	2.51 (3.95 to 13.78)
Serotype 19F	11.7 (7.21 to 19)	6.88 (2.98 to 15.86)	8.51 (1.72 to 5.51)
Serotype 23F	5.24 (3.49 to 7.87)	5.82 (2.97 to 11.4)	6.28 (7.12 to 15.5)
Serotype 1	4.24 (2.48 to 7.26)	0.56 (0.27 to 1.18)	8 (1.7 to 8.74)
Serotype 3	1.24 (0.79 to 1.95)	1.12 (0.56 to 2.25)	1.24 (8.1 to 32.66)
Serotype 5	6 (4.16 to 8.66)	1.43 (0.99 to 2.06)	9.81 (1.86 to 5.5)
Serotype 6A	13.86 (9.69 to 19.83)	4.46 (2.18 to 9.12)	7.37 (2.14 to 9.52)
Serotype 7F	3.55 (2.35 to 5.36)	1.23 (0.69 to 2.21)	3.08 (1.33 to 4.73)
Serotype 19A	13.07 (9.63 to 17.74)	5.09 (3.17 to 8.19)	10.5 (4.38 to 16.55)

Notes
[7] - N= number of subjects with determinate IgG antibody concentration to serotype.
[8] - N= number of subjects with determinate IgG antibody concentration to serotype.
[9] - N= number of subjects with determinate IgG antibody concentration to serotype.

4: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

1.76

4: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.77

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

1.99

4: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.21

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

3.86

6B: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.43

upper limit

1.99

6B: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.09

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

2.22

6B: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.18

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

2.79

9V: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.11

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

2.19

9V: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.09

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

2.06

9V: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.46

upper limit

2.13

14: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.98

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

2.55

14: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.23

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

14: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.25

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

3.72

18C: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.69

Confidence interval

level

95%

sides

2-sided

lower limit

0.29

upper limit

1.68

18C: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.92

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

2.1

18C: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.33

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

3.64

19F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

4.12

19F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.37

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

3.14

19F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.81

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

2.21

23F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.43

upper limit

1.89

23F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.83

Confidence interval

level

95%

sides

2-sided

lower limit

0.42

upper limit

1.67

23F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.93

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

2.16

1: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

7.53

Confidence interval

level

95%

sides

2-sided

lower limit

2.86

upper limit

19.78

1: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.53

Confidence interval

level

95%

sides

2-sided

lower limit

0.22

upper limit

1.31

1: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.07

Confidence interval

level

95%

sides

2-sided

lower limit

0.02

upper limit

0.21

3: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.11

Confidence interval

level

95%

sides

2-sided

lower limit

0.53

upper limit

2.3

3: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.97

3: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.39

upper limit

2.07

5: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

4.2

Confidence interval

level

95%

sides

2-sided

lower limit

2.18

upper limit

8.09

5: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.61

Confidence interval

level

95%

sides

2-sided

lower limit

0.33

upper limit

1.13

5: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.15

Confidence interval

level

95%

sides

2-sided

lower limit

0.07

upper limit

0.31

6A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

3.11

Confidence interval

level

95%

sides

2-sided

lower limit

1.51

upper limit

6.4

6A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/13vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.88

Confidence interval

level

95%

sides

2-sided

lower limit

0.96

upper limit

3.69

6A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.27

upper limit

1.37

7F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

2.88

Confidence interval

level

95%

sides

2-sided

lower limit

1.39

upper limit

5.98

7F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.15

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

2.28

7F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.17

upper limit

0.92

19A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

2.57

Confidence interval

level

95%

sides

2-sided

lower limit

1.5

upper limit

4.39

19A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

1.24

Confidence interval

level

95%

sides

2-sided

lower limit

0.75

upper limit

2.05

19A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMC ratio

Point estimate

0.48

Confidence interval

level

95%

sides

2-sided

lower limit

0.26

upper limit

0.89

Secondary: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine

Top of page

End point title

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine

End point description

Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the subjects using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Evaluable immunogenicity population. n= number of subjects with a determinate OPA antibody titer to the given serotype. -99999 to 99999 for 13vPnC/13vPnC/13vPnC= Since all values for serotype 5 in 13v/13v/13v treatment arm was less than lower limit of quantification (LLOQ), values was set to 0.5 multiplied by (*)limit of detection (LOD [8]) = 4. Hence variability (standard error) could not be estimated; CI was not estimable. -99999 to 99999 for 7vPnC/7vPnC/13vPnC= Since all values for serotype 5 in 7v/7v/13v treatment arm was less than LLOQ, values was set to 0.5*LOD (8) = 4. Hence variability (standard error) could not be estimated; CI was not estimable.

End point type

Secondary

End point timeframe

Up to 7 days before vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	44 ^[10]	18 ^[11]	22 ^[12]
Units: Geometric mean titers
geometric mean (confidence interval 95%)
Serotype 4 (n= 40, 14, 19)	8 (4.4 to 13.1)	46 (7.8 to 268.5)	45 (10.6 to 190.6)
Serotype 6B (n= 38, 16, 21)	245 (92.6 to 646.9)	247 (49.1 to 1241.8)	332 (84.4 to 1304.3)
Serotype 9V (n= 40, 18, 21)	43 (16.3 to 111.9)	36 (8.6 to 149.1)	52 (14.6 to 187.8)
Serotype 14 (n= 39, 16, 20)	98 (39.7 to 242.9)	40 (9.2 to 174.2)	49 (14.4 to 163.9)
Serotype 18C (n= 42, 17, 19)	14 (6.9 to 27.7)	76 (15.7 to 363)	28 (7.2 to 109.7)
Serotype 19F (n= 43, 17, 21)	48 (20.8 to 112.5)	49 (13 to 182.6)	40 (14 to 112.5)
Serotype 23F (n= 43, 16, 21)	52 (22.5 to 120.3)	61 (13.1 to 284.3)	178 (54.6 to 578.7)
Serotype 1 (n= 44, 18, 22)	6 (4.5 to 7.5)	5 (3.4 to 6.5)	10 (6.9 to 15)
Serotype 3 (n= 42, 17, 21)	20 (11.8 to 34.6)	10 (4.4 to 22.2)	18 (12.1 to 28)
Serotype 5 (n= 44, 18, 22)	4 (-99999 to 99999)	4 (-99999 to 99999)	4 (3.6 to 5.6)
Serotype 6A (n= 44, 16, 21)	170 (72.8 to 395.5)	10 (3.4 to 31.4)	75 (22.3 to 253.9)
Serotype 7F (n= 39, 16, 21)	60 (22.5 to 157.8)	47 (10 to 225.2)	389 (112 to 1351.1)
Serotype 19A (n= 41, 18, 20)	118 (58.2 to 239.7)	25 (7.4 to 82)	124 (46.4 to 330.2)

Notes
[10] - N= number of subjects analysed within a given treatment group.
[11] - N= number of subjects analysed within a given treatment group.
[12] - N= number of subjects analysed within a given treatment group.

4: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT Ratio

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.04

upper limit

0.73

4: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT Ratio

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.04

upper limit

0.64

4: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT Ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.19

upper limit

5.46

6B: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.17

upper limit

5.85

6B: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.15

upper limit

3.72

6B: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

5.37

9V: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

6.25

9V: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.17

upper limit

3.92

9V: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

4.43

14: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

2.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

12.35

14: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.45

upper limit

9.05

14: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.13

upper limit

5.14

18C: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.04

upper limit

0.8

18C: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.12

upper limit

2.03

18C: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

14.92

19F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

4.36

19F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.31

upper limit

4.84

19F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

6.65

23F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.17

upper limit

4.17

23F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.07

upper limit

1.24

23F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

2.08

1: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.97

1: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

0.88

1: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.27

upper limit

0.77

3: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

4.9

3: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

2.48

3: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

1.45

5: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.87

upper limit

1.15

5: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.03

5: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.76

upper limit

1.06

6A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

16.5

Confidence interval

level

95%

sides

2-sided

lower limit

3.56

upper limit

76.14

6A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

9.06

6A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.02

upper limit

0.78

7F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.22

upper limit

7.07

7F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.03

upper limit

0.74

7F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.02

upper limit

0.84

19A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

4.8

Confidence interval

level

95%

sides

2-sided

lower limit

1.35

upper limit

16.98

19A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.28

upper limit

3.23

19A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.05

upper limit

0.85

Secondary: Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine

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End point title

Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine

End point description

Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the subjects using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Evaluable immunogenicity population. n= number of subjects with a determinate OPA antibody titer to the given serotype.

End point type

Secondary

End point timeframe

One month after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	120 ^[13]	57 ^[14]	58 ^[15]
Units: Geometric mean titers
geometric mean (confidence interval 95%)
Serotype 4 (n= 117, 53, 55)	5465 (4698.9 to 6356.4)	5208 (4301.7 to 6304.2)	5487 (4236.9 to 7106.4)
Serotype 6B (n= 117, 57, 56)	6684 (5638.4 to 7924.4)	10042 (7697.5 to 13101.6)	8983 (7006.9 to 11516.8)
Serotype 9V (n= 116, 54, 55)	5120 (4456.1 to 5882.6)	4052 (3291 to 4989.7)	5221 (4110.4 to 6630.7)
Serotype 14 (n= 115, 54, 55)	2780 (2374.7 to 3254.6)	3079 (2450.6 to 3869.4)	2979 (2232.9 to 3973.4)
Serotype 18C (n= 117, 54, 57)	7711 (6589.6 to 9023.3)	7091 (5655.9 to 8889.9)	8431 (6740.3 to 10545.7)
Serotype 19F (n= 118, 57, 57)	1319 (1030.5 to 1689.5)	1721 (1316.8 to 2250.3)	1914 (1350.6 to 2712.5)
Serotype 23F (n= 118, 53, 56)	2427 (2063.6 to 2855)	2411 (1792.5 to 3242.4)	2673 (2091.2 to 3417.3)
Serotype 1 (n= 119, 56, 57)	613 (525.2 to 715.7)	197 (161.4 to 239.4)	1212 (968 to 1516.9)
Serotype 3 (n= 118, 56, 58)	244 (214.7 to 276.4)	173 (139.5 to 214.5)	291 (239.4 to 353.7)
Serotype 5 (n= 118, 55, 54)	455 (358.7 to 537.9)	390 (281.2 to 541.8)	728 (545 to 972.2)
Serotype 6A (n= 117, 55, 55)	5580 (4593.6 to 6777)	5596 (4276.6 to 7321.2)	5982 (4450.7 to 8041.1)
Serotype 7F (n= 118, 56, 54)	4323 (3794.4 to 4925.1)	8048 (6500.9 to 9962.2)	4056 (3092.2 to 5321.2)
Serotype 19A (n= 116, 53, 54)	1212 (1048.1 to 1400.7)	1249 (956.5 to 1632.3)	1568 (1249.7 to 1966.1)

Notes
[13] - N= number of subjects analysed within a given treatment group
[14] - N= number of subjects analysed within a given treatment group
[15] - N= number of subjects analysed within a given treatment group

4: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT Ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

1.38

4: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT Ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.76

upper limit

1.3

4: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT Ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.69

upper limit

1.3

6B: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.49

upper limit

0.9

6B: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/13vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.55

upper limit

1.01

6B: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.59

9V: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.98

upper limit

1.63

9V: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/13vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.76

upper limit

1.27

9V: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

1.05

14: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

1.21

14: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.25

14: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

1.46

18C: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

1.43

18C: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.2

18C: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.15

19F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

1.15

19F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.46

upper limit

1.03

19F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

1.44

23F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.74

upper limit

1.37

23F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

1.23

23F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.63

upper limit

1.29

1: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

3.1

Confidence interval

level

95%

sides

2-sided

lower limit

2.4

upper limit

4.06

1: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.39

upper limit

0.66

1: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.12

upper limit

0.22

3: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.11

upper limit

1.78

3: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

1.06

3: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.45

upper limit

0.78

5: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.84

upper limit

1.62

5: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.45

upper limit

0.87

5: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.36

upper limit

0.79

6A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.71

upper limit

1.4

6A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.66

upper limit

1.31

6A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.63

upper limit

1.39

7F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.41

upper limit

0.7

7F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1.38

7F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.46

upper limit

2.69

19A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.74

upper limit

1.28

19A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.59

upper limit

1.02

19A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

GMT ratio

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.58

upper limit

1.1

Secondary: Percentage of Subjects With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine

Top of page

End point title

Percentage of Subjects With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine

End point description

Percentage of subjects with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all subjects. The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.

End point type

Secondary

End point timeframe

One month after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	0 ^[16]	0 ^[17]	0 ^[18]
Units: percentage of subjects
number (not applicable)

Notes
[16] - The data was not collected as planned, instead LLOQ was used for the mcOPA assay.
[17] - The data was not collected as planned, instead LLOQ was used for the mcOPA assay.
[18] - The data was not collected as planned, instead LLOQ was used for the mcOPA assay.

No statistical analyses for this end point

Secondary: Percentage of Subjects With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine

Top of page

End point title

Percentage of Subjects With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine

End point description

Percentage of subjects with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all subjects. The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.

End point type

Secondary

End point timeframe

One month after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	0 ^[19]	0 ^[20]	0 ^[21]
Units: percentage of subjects
number (not applicable)

Notes
[19] - The data was not collected as planned, instead LLOQ was used for the mcOPA assay.
[20] - The data was not collected as planned, instead LLOQ was used for the mcOPA assay.
[21] - The data was not collected as planned, instead LLOQ was used for the mcOPA assay.

No statistical analyses for this end point

Post-hoc: Percentage of Subjects Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine

Top of page

End point title

Percentage of Subjects Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine

End point description

Percentage of subjects achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all subjects using mcOPA assay. Exact 2-sided CI based on observed proportion of subjects. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5*LOD for analysis. Evaluable immunogenicity population. n= number of subjects with a determinate OPA antibody titer to the given serotype.

End point type

Post-hoc

End point timeframe

One month after vaccination

End point values	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Number of subjects analysed	120 ^[22]	57 ^[23]	58 ^[24]
Units: percentage of subjects
number (confidence interval 95%)
Serotype 4 (n= 117, 53, 55)	100 (96.9 to 100)	100 (93.3 to 100)	100 (93.5 to 100)
Serotype 6B (n= 117, 57, 56)	100 (96.9 to 100)	100 (93.7 to 100)	100 (93.6 to 100)
Serotype 9V (n= 116, 54, 55)	100 (96.9 to 100)	100 (93.4 to 100)	100 (93.5 to 100)
Serotype 14 (n= 115, 54, 55)	100 (96.8 to 100)	100 (93.4 to 100)	100 (93.5 to 100)
Serotype 18C (n= 117, 54, 57)	100 (96.9 to 100)	100 (93.4 to 100)	100 (93.7 to 100)
Serotype 19F (n= 118, 57, 57)	98.3 (94 to 99.8)	100 (93.7 to 100)	98.2 (90.6 to 100)
Serotype 23F (n= 118, 53, 56)	100 (96.9 to 100)	100 (93.3 to 100)	100 (93.6 to 100)
Serotype 1 (n= 119, 56, 57)	100 (96.9 to 100)	100 (93.6 to 100)	100 (93.7 to 100)
Serotype 3 (n= 118, 56, 58)	100 (96.9 to 100)	98.2 (90.4 to 100)	100 (93.8 to 100)
Serotype 5 (n= 118, 55, 54)	99.2 (95.4 to 100)	96.4 (87.5 to 99.6)	100 (93.4 to 100)
Serotype 6A (n= 117, 55, 55)	100 (96.9 to 100)	100 (93.5 to 100)	100 (93.5 to 100)
Serotype 7F (n= 118, 56, 54)	100 (96.9 to 100)	100 (93.6 to 100)	100 (93.4 to 100)
Serotype 19A (n= 116, 53, 54)	100 (96.9 to 100)	100 (93.3 to 100)	100 (93.4 to 100)

Notes
[22] - N= number of subjects analysed within a given treatment group.
[23] - N= number of subjects analysed within a given treatment group.
[24] - N= number of subjects analysed within a given treatment group.

4: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

6.7

4: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.5

4: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.8

upper limit

6.6

6B: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

6.3

6B: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.4

upper limit

6.5

6B: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.4

9V: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.6

9V: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.5

9V: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

6.5

14: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

6.6

14: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

6.5

18C: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.6

14: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

6.5

18C: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

6.3

18C: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.6

upper limit

6.4

19F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-6.2

upper limit

4.5

19F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-4.8

upper limit

7.5

19F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.8

upper limit

9.5

23F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

6.7

23F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.4

1: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

6.4

23F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

6.5

1: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.3

1: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.5

upper limit

6.3

3: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

9.6

3: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/13vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

6.2

3: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-9.6

upper limit

4.5

5: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

11.3

5: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

5.6

5: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

-3.6

Confidence interval

level

95%

sides

2-sided

lower limit

-12.5

upper limit

3.2

6A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.5

6A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Comparison groups

7vPnC/7vPnC/13vPnC v 13vPnC/13vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.5

6A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.6

upper limit

6.6

7F: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.4

7F: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

6.6

7F: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.5

upper limit

6.7

19A: 13vPnC/13vPnC/13vPnC vs 7vPnC/7vPnC/13vPnC

Statistical analysis description

Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/7vPnC/13vPnC

Number of subjects included in analysis

177

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.7

19A: 13vPnC/13vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Comparison groups

13vPnC/13vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

6.6

19A: 7vPnC/7vPnC/13vPnC vs. 7vPnC/13vPnC/13vPnC

Statistical analysis description

Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of subjects achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of subjects achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.

Comparison groups

7vPnC/7vPnC/13vPnC v 7vPnC/13vPnC/13vPnC

Number of subjects included in analysis

115

Analysis specification

Pre-specified

Analysis type

superiority

Method

Parameter type

Percent Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.8

upper limit

6.6

Adverse events

Top of page

Timeframe for reporting adverse events

AEs/SAEs: recorded from signing of informed consent form to completion of study (28-42 days post 13vPnC). Subjects recorded prespecified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (Day 1-Day 7 post 13vPnC).

Adverse event reporting additional description

Adverse events(AEs) and Serious AEs were grouped by system organ class and summarized. AEs included solicited/unsolicited AEs collected in electronic diary(local and systemic reactions;systematic assessment) collected on case report form at each visit(nonsystematic assessment).LRs/SEs were assessed only for infant and toddler dose groups.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

0.0

Reporting group title

13vPnC/13vPnC/13vPnC

Reporting group description

Single dose of 13vPnC, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.

Reporting group title

7vPnC/7vPnC/13vPnC

Reporting group description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.

Reporting group title

7vPnC/13vPnC/13vPnC

Reporting group description

Single dose of 13vPnC vaccine, 2 years after receiving a full schedule of (3 infant doses/1 toddler dose) 7vPnC/13vPnC vaccine.

Serious adverse events	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 130 (0.00%)	0 / 64 (0.00%)	0 / 64 (0.00%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC
Total subjects affected by non serious adverse events
subjects affected / exposed	82 / 130 (63.08%)	36 / 64 (56.25%)	39 / 64 (60.94%)
Injury, poisoning and procedural complications
Radius fracture
subjects affected / exposed	0 / 130 (0.00%)	0 / 64 (0.00%)	1 / 64 (1.56%)
occurrences all number	0	0	1
General disorders and administration site conditions
Injection site erythema
subjects affected / exposed	1 / 130 (0.77%)	0 / 64 (0.00%)	0 / 64 (0.00%)
occurrences all number	1	0	0
Fever >=38 degree C but <=39 degree C
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[1]	14 / 93 (15.05%)	14 / 49 (28.57%)	9 / 46 (19.57%)
occurrences all number	14	14	9
Fever >39 degree C but <=40 degree C
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[2]	2 / 92 (2.17%)	2 / 43 (4.65%)	1 / 46 (2.17%)
occurrences all number	2	2	1
Fever >40 degree C
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[3]	0 / 90 (0.00%)	0 / 43 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	1
Vomiting (Any)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[4]	3 / 91 (3.30%)	4 / 44 (9.09%)	3 / 45 (6.67%)
occurrences all number	3	4	3
Vomiting (Mild)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[5]	3 / 91 (3.30%)	4 / 44 (9.09%)	3 / 45 (6.67%)
occurrences all number	3	4	3
Diarrhea (Any)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[6]	8 / 90 (8.89%)	8 / 45 (17.78%)	4 / 47 (8.51%)
occurrences all number	8	8	4
Diarrhea (Mild)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[7]	8 / 90 (8.89%)	8 / 45 (17.78%)	4 / 47 (8.51%)
occurrences all number	8	8	4
Diarrhea (Moderate)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[8]	1 / 90 (1.11%)	0 / 43 (0.00%)	0 / 45 (0.00%)
occurrences all number	1	0	0
Fatigue (Any)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[9]	42 / 103 (40.78%)	28 / 54 (51.85%)	15 / 48 (31.25%)
occurrences all number	42	28	15
Fatigue (Mild)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[10]	34 / 100 (34.00%)	17 / 49 (34.69%)	10 / 48 (20.83%)
occurrences all number	34	17	10
Fatigue (Moderate)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[11]	16 / 96 (16.67%)	15 / 49 (30.61%)	7 / 46 (15.22%)
occurrences all number	16	15	7
Fatigue (Severe)
Additional description: Subjects affected and occurrences for SEs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Systemic Event 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[12]	3 / 92 (3.26%)	1 / 43 (2.33%)	1 / 45 (2.22%)
occurrences all number	3	1	1
Respiratory, thoracic and mediastinal disorders
Epistaxis
subjects affected / exposed	0 / 130 (0.00%)	1 / 64 (1.56%)	0 / 64 (0.00%)
occurrences all number	0	1	0
Oropharyngeal pain
subjects affected / exposed	1 / 130 (0.77%)	0 / 64 (0.00%)	0 / 64 (0.00%)
occurrences all number	1	0	0
Skin and subcutaneous tissue disorders
Dermatitis allergic
subjects affected / exposed	0 / 130 (0.00%)	1 / 64 (1.56%)	0 / 64 (0.00%)
occurrences all number	0	1	0
Pain (Any)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[13]	62 / 112 (55.36%)	29 / 52 (55.77%)	34 / 53 (64.15%)
occurrences all number	62	29	34
Pain (Mild)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[14]	55 / 109 (50.46%)	25 / 51 (49.02%)	29 / 51 (56.86%)
occurrences all number	55	25	29
Pain (Moderate)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[15]	17 / 95 (17.89%)	12 / 47 (25.53%)	10 / 48 (20.83%)
occurrences all number	17	12	10
Pain (Severe)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[16]	1 / 90 (1.11%)	1 / 43 (2.33%)	1 / 45 (2.22%)
occurrences all number	1	1	1
Swelling (Any)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[17]	40 / 101 (39.60%)	20 / 48 (41.67%)	13 / 47 (27.66%)
occurrences all number	40	20	13
Swelling (Mild)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[18]	27 / 96 (28.13%)	17 / 48 (35.42%)	11 / 47 (23.40%)
occurrences all number	27	17	11
Swelling (Moderate)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[19]	24 / 97 (24.74%)	9 / 44 (20.45%)	5 / 46 (10.87%)
occurrences all number	24	9	5
Swelling (Severe)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[20]	0 / 90 (0.00%)	1 / 43 (2.33%)	0 / 45 (0.00%)
occurrences all number	0	1	0
Redness (Any)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[21]	51 / 105 (48.57%)	27 / 50 (54.00%)	23 / 50 (46.00%)
occurrences all number	51	27	23
Redness (Mild)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[22]	39 / 101 (38.61%)	20 / 49 (40.82%)	18 / 48 (37.50%)
occurrences all number	39	20	18
Redness (Moderate)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[23]	21 / 95 (22.11%)	14 / 45 (31.11%)	8 / 47 (17.02%)
occurrences all number	21	14	8
Redness (Severe)
Additional description: Subjects affected and occurrences for LRs is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination. Version not captured, here 0.0 is mentioned for dictionary version.
alternative dictionary used: Local Reaction 0.0
alternative assessment type: Systematic
subjects affected / exposed ^[24]	0 / 90 (0.00%)	1 / 43 (2.33%)	0 / 45 (0.00%)
occurrences all number	0	1	0
Infections and infestations
Acute tonsillitis
subjects affected / exposed	1 / 130 (0.77%)	0 / 64 (0.00%)	0 / 64 (0.00%)
occurrences all number	1	0	0
Bronchitis
subjects affected / exposed	2 / 130 (1.54%)	0 / 64 (0.00%)	0 / 64 (0.00%)
occurrences all number	2	0	0
Ear infection
subjects affected / exposed	0 / 130 (0.00%)	1 / 64 (1.56%)	1 / 64 (1.56%)
occurrences all number	0	1	1
Gastroenteritis
subjects affected / exposed	1 / 130 (0.77%)	1 / 64 (1.56%)	1 / 64 (1.56%)
occurrences all number	1	1	1
Nasopharyngitis
subjects affected / exposed	3 / 130 (2.31%)	0 / 64 (0.00%)	0 / 64 (0.00%)
occurrences all number	3	0	0
Pharyngitis
subjects affected / exposed	2 / 130 (1.54%)	0 / 64 (0.00%)	1 / 64 (1.56%)
occurrences all number	2	0	1
Rhinitis
subjects affected / exposed	0 / 130 (0.00%)	1 / 64 (1.56%)	0 / 64 (0.00%)
occurrences all number	0	1	0
Tonsillitis
subjects affected / exposed	2 / 130 (1.54%)	1 / 64 (1.56%)	1 / 64 (1.56%)
occurrences all number	2	1	1
Urinary tract infection
subjects affected / exposed	1 / 130 (0.77%)	0 / 64 (0.00%)	0 / 64 (0.00%)
occurrences all number	1	0	0
Varicella
subjects affected / exposed	2 / 130 (1.54%)	0 / 64 (0.00%)	1 / 64 (1.56%)
occurrences all number	2	0	1
Viral infection
subjects affected / exposed	2 / 130 (1.54%)	1 / 64 (1.56%)	0 / 64 (0.00%)
occurrences all number	2	1	0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
[24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine

Primary: Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine

Primary: Percentage of Subjects with Prespecified Local Reactions

Primary: Percentage of Subjects with Prespecified Local Reactions

Primary: Percentage of Subjects With Prespecified Systemic Events

Primary: Percentage of Subjects With Prespecified Systemic Events

Secondary: Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine

Secondary: Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine

Secondary: Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine

Secondary: Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine

Secondary: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine

Secondary: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine

Secondary: Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine

Secondary: Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine

Secondary: Percentage of Subjects With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine

Secondary: Percentage of Subjects With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine

Secondary: Percentage of Subjects With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine

Secondary: Percentage of Subjects With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine

Post-hoc: Percentage of Subjects Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine

Post-hoc: Percentage of Subjects Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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