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Clinical Trial Results:
Characterization of the Prevnar Infant Long-Term Immune Response Versus a Prevnar-Naive Cohort

Summary
EudraCT number	2014-004158-32
Trial protocol	Outside EU/EEA
Global end of trial date	10 May 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

6096A1-3016

ISRCTN number

US NCT number

NCT00824850

WHO universal trial number (UTN)

Other trial identifiers

Alias: B1851014

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

13 Jun 2011

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

10 May 2010

Was the trial ended prematurely?

Main objective of the trial

To characterize the “late” immune response to an additional dose of pneumococcal conjugate vaccine more than 10 years after primary vaccination with 7-valent pneumococcal conjugate vaccine (7vPnC) in infancy versus a 7vPnC-naive cohort, to evaluate kinetics of secondary immune responses in order to measure serotype-specific anti-pneumococcal immunoglobulin G (IgG) and OPA titer and to evaluate the safety profile of 13-valent pneumococcal conjugate vaccine (13vPnC) as measured by the rate of serious adverse events (SAEs), adverse events (AEs), and solicited local reactions and systemic events in the 2 groups.

Protection of trial subjects

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

Background therapy

Evidence for comparator

Actual start date of recruitment

26 Jan 2010

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

6 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 75

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

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

Subjects were previously enrolled in Prevnar protocol D118-P8 (study duration 1995 to 1998) and were randomized to receive either 7vPnC or meningococcal C conjugate vaccine (MnCC) in that study.

Screening details

A total of 75 subjects were screened in two sites of United States. Study was started on 26 January 2010 and completed on 10 May 2010.

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

7vPnC / 13vPnC

Arm description

13vPnC administered as a single dose. Subjects had previously received 7vPnC in study D118-P8.

Arm type

Experimental

Investigational medicinal product name

7-valent pneumococcal conjugate vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects had previously received 7vPnC in study D118-P8.

Investigational medicinal product name

13-valent Pneumococcal Conjugate Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects were administered with 13vPnC as a single 0.5 milliliter (mL) dose intramuscularly (IM).

MnCC / 13vPnC

Arm description

13vPnC administered as a single dose. Subjects had previously received MnCC in study D118-P8.

Arm type

Experimental

Investigational medicinal product name

Meningococcal C conjugate

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects had previously received MnCC in study D118-P8.

Investigational medicinal product name

13-valent Pneumococcal Conjugate Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intramuscular use

Dosage and administration details

Subjects were administered with 13vPnC as a single 0.5 mL dose IM.

Number of subjects in period 1	7vPnC / 13vPnC	MnCC / 13vPnC
Started	38	37
Received Vaccination 13vPnC	38	36
Completed	38	36
Not completed	0	1
Consent withdrawn by subject	-	1

Baseline characteristics

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Reporting group title

7vPnC / 13vPnC

Reporting group description

13vPnC administered as a single dose. Subjects had previously received 7vPnC in study D118-P8.

Reporting group title

MnCC / 13vPnC

Reporting group description

13vPnC administered as a single dose. Subjects had previously received MnCC in study D118-P8.

Reporting group values	7vPnC / 13vPnC	MnCC / 13vPnC	Total
Number of subjects	38	37	75
Age categorical
Units: Subjects
Age Continuous
Units: years
arithmetic mean (standard deviation)	12.6 ( 1.1 )	13.1 ( 0.9 )	-
Gender, Male/Female
Units: subjects
Female	15	16	31
Male	23	21	44

End points

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Reporting group title

7vPnC / 13vPnC

Reporting group description

13vPnC administered as a single dose. Subjects had previously received 7vPnC in study D118-P8.

Reporting group title

MnCC / 13vPnC

Reporting group description

13vPnC administered as a single dose. Subjects had previously received MnCC in study D118-P8.

Subject analysis set title

7vPnC / 13vPnC prevaccination Visit 1

Subject analysis set type

Full analysis

Subject analysis set description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received 7vPnC in study D118-P8.

Subject analysis set title

7vPnC / 13vPnC postvaccination Visit 5

Subject analysis set type

Full analysis

Subject analysis set description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received 7vPnC in study D118-P8.

Subject analysis set title

MnCC / 13vPnC prevaccination Visit 1

Subject analysis set type

Full analysis

Subject analysis set description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received MnCC in study D118-P8.

Subject analysis set title

MnCC / 13vPnC postvaccination Visit 5

Subject analysis set type

Full analysis

Subject analysis set description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received MnCC in study D118-P8.

Subject analysis set title

7vPnC / 13vPnC postvaccination Visit 4

Subject analysis set type

Full analysis

Subject analysis set description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received 7vPnC in study D118-P8.

Subject analysis set title

MnCC / 13vPnC postvaccination Visit 4

Subject analysis set type

Full analysis

Subject analysis set description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received MnCC in study D118-P8.

Primary: Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration Greater Than or Equal to (≥) 0.35 Microgram per Milliliter (mcg/mL) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

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End point title

Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration Greater Than or Equal to (≥) 0.35 Microgram per Milliliter (mcg/mL) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

End point description

Percentage of subjects achieving predefined IgG antibody threshold ≥0.35 mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% confidence intervals (CIs) based on the observed percentage of subjects. Evaluable Immunogenicity population: eligible subjects based on all inclusion and exclusion criteria, had a baseline blood sample collection performed (Visit 1), received 1 dose of 13vPnC, and had Visit 5 blood sample collection performed, and at least 1 valid and determinate assay result at Visit 1 and also at Visit 5.

End point type

Primary

End point timeframe

Day 28 (Visit 5)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	35
Units: observed percentage of subjects
number (confidence interval 95%)
7vPnC serotype 4	100 (90.7 to 100)	100 (90 to 100)
7vPnC serotype 6B	100 (90.7 to 100)	100 (90 to 100)
7vPnC serotype 9V	100 (90.7 to 100)	100 (90 to 100)
7vPnC serotype 14	100 (90.7 to 100)	97.1 (85.1 to 99.9)
7vPnC serotype 18C	100 (90.7 to 100)	100 (90 to 100)
7vPnC serotype 19F	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 23F	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 1	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 3	94.7 (82.3 to 99.4)	97 (84.2 to 99.9)
Additional serotype 5	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 6A	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 7F	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 19A	100 (90.7 to 100)	100 (90 to 100)

7vPnC serotype 4

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided confidence interval (CI).

Comparison groups

MnCC / 13vPnC v 7vPnC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[1]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[1] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[2]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[2] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[3]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[3] - Descriptive

7vPnC serotype 14

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[4]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.9

upper limit

14.9

Notes
[4] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[5]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[5] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[6]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[6] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[7]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[7] - Descriptive

Additional serotype 3

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[8]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-15.7

upper limit

10.9

Notes
[8] - Descriptive

Additional serotype 1

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[9]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[9] - Descriptive

Additional serotype 5

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[10]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[10] - Descriptive

Additional serotype 7F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[11]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[11] - Descriptive

Additional serotype 6A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[12]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[12] - Descriptive

Additional serotype 19A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[13]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[13] - Descriptive

Primary: Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

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End point title

Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

End point description

End point type

Primary

End point timeframe

Day 7 (Visit 4)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38 ^[14]	35 ^[15]
Units: observed percentage of subjects
number (confidence interval 95%)
7vPnC serotype 4	94.7 (82.3 to 99.4)	85.7 (69.7 to 95.2)
7vPnC serotype 6B	100 (90.7 to 100)	100 (90 to 100)
7vPnC serotype 9V	100 (90.7 to 100)	97.1 (85.1 to 99.9)
7vPnC serotype 14	100 (90.7 to 100)	94.3 (80.8 to 99.3)
7vPnC serotype 18C	97.4 (86.2 to 99.9)	94.3 (80.8 to 99.3)
7vPnC serotype 19F	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 23F	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 1	100 (90.7 to 100)	97.1 (85.1 to 99.9)
Additional serotype 3	94.7 (82.3 to 99.4)	87.9 (71.8 to 96.6)
Additional serotype 5	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 6A	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 7F	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 19A	100 (90.7 to 100)	100 (90 to 100)

Notes
[14] - Number of subjects with a determinate IgG antibody concentration for the serotypes.
[15] - Number of subjects with a determinate IgG antibody concentration for the serotypes.

7vPnC serotype 6B

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[16]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[16] - Descriptive

7vPnC serotype 4

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[17]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-5.6

upper limit

25.5

Notes
[17] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[18]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.9

upper limit

14.9

Notes
[18] - Descriptive

7vPnC serotype 14

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[19]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-4.2

upper limit

19.2

Notes
[19] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[20]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[20] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[21]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9.3

upper limit

Notes
[21] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[22]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[22] - Descriptive

Additional serotype 1

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[23]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.9

upper limit

14.9

Notes
[23] - Descriptive

Additional serotype 3

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[24]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

6.9

Confidence interval

level

95%

sides

2-sided

lower limit

-7.4

upper limit

23.4

Notes
[24] - Descriptive

Additional serotype 5

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[25]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[25] - Descriptive

Additional serotype 6A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[26]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[26] - Descriptive

Additional serotype 7F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[27]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[27] - Descriptive

Additional serotype 19A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[28]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[28] - Descriptive

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥Lower Limit of Quantification (LLOQ) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Top of page

End point title

Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥Lower Limit of Quantification (LLOQ) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

End point description

Percentage of subjects achieving predefined OPA antibody titer ≥serotype-specific LLOQ using modified microcolony assays for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of subjects. LLOQ for each serotype: 1=1:8, 3=1:12, 4=1:21, 5=1:29, 6A=1:37, 6B=1:43, 7F=1:210, 9V=1:345, 14=1:35, 18C=1:31, 19A=1:18, 19F=1:48, 23F=1:13. Evaluable Immunogenicity population.

End point type

Primary

End point timeframe

Day 28 (Visit 5)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38 ^[29]	35 ^[30]
Units: observed percentage of subjects
number (confidence interval 95%)
7vPnC serotype 4	100 (90.3 to 100)	100 (89.1 to 100)
7vPnC serotype 6B	100 (90.5 to 100)	100 (90 to 100)
7vPnC serotype 9V	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 14	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 18C	100 (90.7 to 100)	100 (90 to 100)
7vPnC serotype 19F	97.4 (86.2 to 99.9)	100 (89.7 to 100)
7vPnC serotype 23F	100 (90.5 to 100)	100 (90 to 100)
Additional serotype 1	100 (90.7 to 100)	97.1 (84.7 to 99.9)
Additional serotype 3	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 5	89.5 (75.2 to 97.1)	88.6 (73.3 to 96.8)
Additional serotype 6A	100 (90.7 to 100)	100 (89.7 to 100)
Additional serotype 7F	100 (90.5 to 100)	100 (90 to 100)
Additional serotype 19A	97.4 (86.2 to 99.9)	100 (90 to 100)

Notes
[29] - Number of subjects with a determinate OPA antibody titer to the serotypes.
[30] - Number of subjects with a determinate OPA antibody titer to the serotypes.

7vPnC serotype 4

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[31]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10.2

upper limit

10.9

Notes
[31] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[32]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[32] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[33]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[33] - Descriptive

7vPnC serotype 14

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[34]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[34] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[35]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[35] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[36]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-13.9

upper limit

Notes
[36] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[37]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[37] - Descriptive

Additional serotype 1

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[38]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

15.3

Notes
[38] - Descriptive

Additional serotype 3

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[39]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[39] - Descriptive

Additional serotype 5

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[40]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-15

upper limit

17.6

Notes
[40] - Descriptive

Additional serotype 6A

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[41]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[41] - Descriptive

Additional serotype 7F

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[42]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[42] - Descriptive

Additional serotype 19A

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[43]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-13.9

upper limit

7.6

Notes
[43] - Descriptive

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Top of page

End point title

Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

End point description

End point type

Primary

End point timeframe

Day 7 (Visit 4)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38 ^[44]	35 ^[45]
Units: observed percentage of subjects
number (confidence interval 95%)
7vPnC serotype 4	97.4 (86.2 to 99.9)	100 (89.7 to 100)
7vPnC serotype 6B	100 (90.7 to 100)	100 (89.4 to 100)
7vPnC serotype 9V	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 14	100 (90.5 to 100)	100 (89.7 to 100)
7vPnC serotype 18C	100 (90.5 to 100)	100 (90 to 100)
7vPnC serotype 19F	94.3 (80.8 to 99.3)	97.1 (84.7 to 99.9)
7vPnC serotype 23F	97.3 (85.8 to 99.9)	94.3 (80.8 to 99.3)
Additional serotype 1	100 (90.5 to 100)	97.1 (85.1 to 99.9)
Additional serotype 3	97.4 (86.2 to 99.9)	100 (89.7 to 100)
Additional serotype 5	89.5 (75.2 to 97.1)	88.2 (72.5 to 96.7)
Additional serotype 6A	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 7F	100 (90.5 to 100)	97 (84.2 to 99.9)
Additional serotype 19A	97.4 (86.2 to 99.9)	100 (90 to 100)

Notes
[44] - Number of subjects with a determinate OPA antibody titer to the serotypes.
[45] - Number of subjects with a determinate OPA antibody titer to the serotypes.

7vPnC serotype 4

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[46]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-13.9

upper limit

Notes
[46] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[47]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10.2

upper limit

10.6

Notes
[47] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[48]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[48] - Descriptive

7vPnC serotype 14

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[49]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

10.3

Notes
[49] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[50]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-16.8

upper limit

10.1

Notes
[50] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[51]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[51] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[52]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.1

upper limit

16.6

Notes
[52] - Descriptive

Additional serotype 1

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[53]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-7.1

upper limit

Notes
[53] - Descriptive

Additional serotype 3

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[54]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-13.9

upper limit

Notes
[54] - Descriptive

Additional serotype 5

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[55]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-14.8

upper limit

18.2

Notes
[55] - Descriptive

Additional serotype 6A

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[56]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[56] - Descriptive

Additional serotype 7F

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[57]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-6.8

upper limit

15.8

Notes
[57] - Descriptive

Additional serotype 19A

Statistical analysis description

Difference in proportions, [7vPnC / 13vPnC) - (MnCC / 13vPnC), expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[58]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-13.9

upper limit

7.6

Notes
[58] - Descriptive

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Top of page

End point title

Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

End point description

Percentage of subjects achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of subjects. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 limit of detection (LOD) and was the same for each serotype-specific OPA assay. Evaluable Immunogenicity population.

End point type

Primary

End point timeframe

Day 28 (Visit 5)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	35 ^[59]
Units: observed percentage of subjects
number (confidence interval 95%)
7vPnC serotype 4	100 (90.3 to 100)	100 (89.1 to 100)
7vPnC serotype 6B	100 (90.5 to 100)	100 (90 to 100)
7vPnC serotype 9V	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 14	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 18C	100 (90.7 to 100)	100 (90 to 100)
7vPnC serotype 19F	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 23F	100 (90.5 to 100)	100 (90 to 100)
Additional serotype 1	100 (90.7 to 100)	100 (89.7 to 100)
Additional serotype 3	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 5	97.4 (86.2 to 99.9)	94.3 (80.8 to 99.3)
Additional serotype 6A	100 (90.7 to 100)	100 (89.7 to 100)
Additional serotype 7F	100 (90.5 to 100)	100 (90 to 100)
Additional serotype 19A	100 (90.7 to 100)	100 (90 to 100)

Notes
[59] - Subjects with a determinate OPA antibody concentration for the serotypes.

7vPnC serotype 4

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[60]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10.2

upper limit

10.9

Notes
[60] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[61]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[61] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[62]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[62] - Descriptive

7vPnC serotype 14

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[63]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[63] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[64]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[64] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[65]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[65] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[66]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[66] - Descriptive

Additional serotype 3

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[67]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[67] - Descriptive

Additional serotype 1

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[68]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[68] - Descriptive

Additional serotype 5

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[69]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9.3

upper limit

Notes
[69] - Descriptive

Additional serotype 6A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[70]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[70] - Descriptive

Additional serotype 7F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[71]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[71] - Descriptive

Additional serotype 19A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[72]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[72] - Descriptive

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Top of page

End point title

End point description

Percentage of subjects achieving predefined OPA antibody titer ≥1:8 for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A) along with the exact, 2-sided 95% CIs based on the observed percentage of subjects. The lowest titer that can be determined using the standard OPA assay is a titer of 1:8 LOD and was the same for each serotype-specific OPA assay. Evaluable Immunogenicity population.

End point type

Primary

End point timeframe

Day 7 (Visit 4)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	35 ^[73]
Units: observed percentage of subjects
number (confidence interval 95%)
7vPnC serotype 4	97.4 (86.2 to 99.9)	100 (89.7 to 100)
7vPnC serotype 6B	100 (90.7 to 100)	100 (89.4 to 100)
7vPnC serotype 9V	100 (90.7 to 100)	100 (89.7 to 100)
7vPnC serotype 14	100 (90.5 to 100)	100 (89.7 to 100)
7vPnC serotype 18C	100 (90.5 to 100)	100 (90 to 100)
7vPnC serotype 19F	100 (90 to 100)	100 (89.7 to 100)
7vPnC serotype 23F	97.3 (85.8 to 99.9)	94.3 (80.8 to 99.3)
Additional serotype 1	100 (90.5 to 100)	100 (90 to 100)
Additional serotype 3	100 (90.7 to 100)	100 (89.7 to 100)
Additional serotype 5	97.4 (86.2 to 99.9)	94.1 (80.3 to 99.3)
Additional serotype 6A	100 (90.7 to 100)	100 (90 to 100)
Additional serotype 7F	100 (90.5 to 100)	100 (89.4 to 100)
Additional serotype 19A	100 (90.7 to 100)	100 (90 to 100)

Notes
[73] - Subjects with a determinate OPA antibody concentration for the serotypes.

7vPnC serotype 6B

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[74]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10.2

upper limit

10.6

Notes
[74] - Descriptive

7vPnC serotype 4

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[75]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-13.9

upper limit

Notes
[75] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[76]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[76] - Descriptive

7vPnC serotype 14

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[77]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

10.3

Notes
[77] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[78]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[78] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[79]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10.1

upper limit

10.5

Notes
[79] - Descriptive

Additional serotype 1

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[80]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

10.1

Notes
[80] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[81]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.1

upper limit

16.6

Notes
[81] - Descriptive

Additional serotype 5

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[82]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

3.3

Confidence interval

level

95%

sides

2-sided

lower limit

-8.6

upper limit

17.2

Notes
[82] - Descriptive

Additional serotype 3

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[83]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

10.3

Notes
[83] - Descriptive

Additional serotype 6A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[84]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[84] - Descriptive

Additional serotype 7F

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[85]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.7

upper limit

10.6

Notes
[85] - Descriptive

Additional serotype 19A

Statistical analysis description

Difference in proportions, [(7vPnC/13vPnC) – (MnCC/13vPnC)], expressed as a percentage, along with exact 2-sided CI.

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[86]

Method

Parameter type

Difference in proportions (percentage)

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-9.5

upper limit

Notes
[86] - Descriptive

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Top of page

End point title

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

End point description

Pneumococcal IgG GMCs measured as mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. Evaluable Immunogenicity population. GMCs calculated using all subjects with available data at both the prevaccination and postvaccination blood draws.

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 28 (Visit 5)

End point values	7vPnC / 13vPnC prevaccination Visit 1	7vPnC / 13vPnC postvaccination Visit 5
Number of subjects analysed	38	38
Units: Mcg/mL
geometric mean (confidence interval 95%)
7vPnC serotype 4	0.2 (0.12 to 0.33)	5.96 (4.1 to 8.65)
7vPnC serotype 6B	5.89 (4.61 to 7.51)	66.72 (50.19 to 88.7)
7vPnC serotype 9V	1.54 (1.19 to 2)	8.62 (6.55 to 11.34)
7vPnC serotype 14	0.58 (0.39 to 0.86)	41.45 (27.72 to 61.97)
7vPnC serotype 18C	0.75 (0.48 to 1.18)	5.93 (4.34 to 8.11)
7vPnC serotype 19F	2.94 (2.08 to 4.15)	13.41 (8.89 to 20.23)
7vPnC serotype 23F	2.51 (1.92 to 3.27)	17.2 (12.44 to 23.77)
Additional serotype 1	1.04 (0.71 to 1.54)	11.59 (7.34 to 18.3)
Additional serotype 3	1.3 (0.83 to 2.04)	2.19 (1.6 to 2.99)
Additional serotype 5	3.24 (2.45 to 4.27)	6.8 (4.75 to 9.74)
Additional serotype 6A	3.78 (2.85 to 5.03)	29.11 (19.04 to 44.5)
Additional serotype 7F	1.38 (0.93 to 2.05)	9.92 (7.03 to 14.01)
Additional serotype 19A	7.05 (5.52 to 8.99)	21.29 (14.9 to 30.43)

7vPnC serotype 4

Statistical analysis description

Geometric mean fold rises (GMFRs) were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CIs for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[87]

Method

Parameter type

geometric mean fold rise

Point estimate

29.47

Confidence interval

level

95%

sides

2-sided

lower limit

17.61

upper limit

49.33

Notes
[87] - Descriptive

7vPnC serotype 6B

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CIs for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[88]

Method

Parameter type

geometric mean fold rise

Point estimate

11.34

Confidence interval

level

95%

sides

2-sided

lower limit

8.49

upper limit

15.13

Notes
[88] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[89]

Method

Parameter type

geometric mean fold rise

Point estimate

5.58

Confidence interval

level

95%

sides

2-sided

lower limit

4.06

upper limit

7.67

Notes
[89] - Descriptive

7vPnC serotype 14

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[90]

Method

Parameter type

geometric mean fold rise

Point estimate

71.09

Confidence interval

level

95%

sides

2-sided

lower limit

40.74

upper limit

124.08

Notes
[90] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[91]

Method

Parameter type

geometric mean fold rise

Point estimate

7.91

Confidence interval

level

95%

sides

2-sided

lower limit

4.92

upper limit

12.73

Notes
[91] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[92]

Method

Parameter type

geometric mean fold rise

Point estimate

4.56

Confidence interval

level

95%

sides

2-sided

lower limit

2.87

upper limit

7.26

Notes
[92] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[93]

Method

Parameter type

geometric mean fold rise

Point estimate

6.85

Confidence interval

level

95%

sides

2-sided

lower limit

4.51

upper limit

10.42

Notes
[93] - Descriptive

Additional serotype 3

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[94]

Method

Parameter type

geometric mean fold rise

Point estimate

1.68

Confidence interval

level

95%

sides

2-sided

lower limit

1.37

upper limit

2.07

Notes
[94] - Descriptive

Additional serotype 1

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[95]

Method

Parameter type

geometric mean fold rise

Point estimate

11.1

Confidence interval

level

95%

sides

2-sided

lower limit

6.98

upper limit

17.64

Notes
[95] - Descriptive

Additional serotype 5

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[96]

Method

Parameter type

geometric mean fold rise

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

1.52

upper limit

2.9

Notes
[96] - Descriptive

Additional serotype 7F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[97]

Method

Parameter type

geometric mean fold rise

Point estimate

7.2

Confidence interval

level

95%

sides

2-sided

lower limit

4.95

upper limit

10.48

Notes
[97] - Descriptive

Additional serotype 6A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[98]

Method

Parameter type

geometric mean fold rise

Point estimate

7.7

Confidence interval

level

95%

sides

2-sided

lower limit

4.77

upper limit

12.42

Notes
[98] - Descriptive

Additional serotype 19A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[99]

Method

Parameter type

geometric mean fold rise

Point estimate

3.02

Confidence interval

level

95%

sides

2-sided

lower limit

2.23

upper limit

4.1

Notes
[99] - Descriptive

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Top of page

End point title

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

End point description

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 28 (Visit 5)

End point values	MnCC / 13vPnC prevaccination Visit 1	MnCC / 13vPnC postvaccination Visit 5
Number of subjects analysed	35	35
Units: Mcg/mL
geometric mean (confidence interval 95%)
7vPnC serotype 4	0.15 (0.07 to 0.29)	2.86 (2 to 4.07)
7vPnC serotype 6B	3.97 (2.78 to 5.67)	22.62 (14.56 to 35.16)
7vPnC serotype 9V	1.69 (1.2 to 2.38)	4.7 (3.49 to 6.33)
7vPnC serotype 14	0.79 (0.43 to 1.43)	18.5 (10.1 to 33.9)
7vPnC serotype 18C	0.72 (0.46 to 1.13)	9.79 (6.43 to 14.9)
7vPnC serotype 19F	2.01 (1.32 to 3.05)	18.02 (11.56 to 28.08)
7vPnC serotype 23F	2.31 (1.7 to 3.14)	20.8 (13.07 to 33.08)
Additional serotype 1	0.7 (0.43 to 1.15)	5.3 (3.4 to 8.26)
Additional serotype 3	1.16 (0.73 to 1.86)	1.81 (1.25 to 2.62)
Additional serotype 5	3.83 (2.77 to 5.31)	7.39 (4.98 to 10.96)
Additional serotype 6A	3.82 (2.79 to 5.23)	17.05 (10.82 to 26.87)
Additional serotype 7F	1.12 (0.73 to 1.72)	5.94 (4.08 to 8.65)
Additional serotype 19A	6.18 (4.57 to 8.35)	20.17 (15.28 to 26.63)

7vPnC serotype 4

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[100]

Method

Parameter type

geometric mean fold rise

Point estimate

19.68

Confidence interval

level

95%

sides

2-sided

lower limit

9.99

upper limit

38.77

Notes
[100] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[101]

Method

Parameter type

geometric mean fold rise

Point estimate

2.78

Confidence interval

level

95%

sides

2-sided

lower limit

2.16

upper limit

3.57

Notes
[101] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[102]

Method

Parameter type

geometric mean fold rise

Point estimate

5.7

Confidence interval

level

95%

sides

2-sided

lower limit

3.9

upper limit

8.33

Notes
[102] - Descriptive

7vPnC serotype 14

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[103]

Method

Parameter type

geometric mean fold rise

Point estimate

23.46

Confidence interval

level

95%

sides

2-sided

lower limit

13.17

upper limit

41.79

Notes
[103] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[104]

Method

Parameter type

geometric mean fold rise

Point estimate

13.68

Confidence interval

level

95%

sides

2-sided

lower limit

8.94

upper limit

20.92

Notes
[104] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[105]

Method

Parameter type

geometric mean fold rise

Point estimate

8.98

Confidence interval

level

95%

sides

2-sided

lower limit

6.21

upper limit

12.97

Notes
[105] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[106]

Method

Parameter type

geometric mean fold rise

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

5.91

upper limit

13.72

Notes
[106] - Descriptive

Additional serotype 3

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[107]

Method

Parameter type

geometric mean fold rise

Point estimate

1.56

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

1.86

Notes
[107] - Descriptive

Additional serotype 1

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[108]

Method

Parameter type

geometric mean fold rise

Point estimate

7.58

Confidence interval

level

95%

sides

2-sided

lower limit

5.36

upper limit

10.72

Notes
[108] - Descriptive

Additional serotype 5

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[109]

Method

Parameter type

geometric mean fold rise

Point estimate

1.93

Confidence interval

level

95%

sides

2-sided

lower limit

1.43

upper limit

2.6

Notes
[109] - Descriptive

Additional serotype 7F

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[110]

Method

Parameter type

geometric mean fold rise

Point estimate

5.32

Confidence interval

level

95%

sides

2-sided

lower limit

3.65

upper limit

7.75

Notes
[110] - Descriptive

Additional serotype 6A

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[111]

Method

Parameter type

geometric mean fold rise

Point estimate

4.46

Confidence interval

level

95%

sides

2-sided

lower limit

3.09

upper limit

6.45

Notes
[111] - Descriptive

Additional serotype 19A

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[112]

Method

Parameter type

geometric mean fold rise

Point estimate

3.27

Confidence interval

level

95%

sides

2-sided

lower limit

2.49

upper limit

4.28

Notes
[112] - Descriptive

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Top of page

End point title

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

End point description

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 7 (Visit 4)

End point values	7vPnC / 13vPnC prevaccination Visit 1	7vPnC / 13vPnC postvaccination Visit 4
Number of subjects analysed	38	38
Units: Mcg/mL
geometric mean (confidence interval 95%)
7vPnC serotype 4	0.2 (0.12 to 0.33)	3.21 (2.1 to 4.9)
7vPnC serotype 6B	5.89 (4.61 to 7.51)	29.46 (20.74 to 41.86)
7vPnC serotype 9V	1.54 (1.19 to 2)	5.96 (4.57 to 7.76)
7vPnC serotype 14	0.58 (0.39 to 0.86)	10.25 (6.85 to 15.33)
7vPnC serotype 18C	0.75 (0.48 to 1.18)	3.17 (2.26 to 4.42)
7vPnC serotype 19F	2.94 (2.08 to 4.15)	7.46 (5.43 to 10.25)
7vPnC serotype 23F	2.51 (1.92 to 3.27)	10.56 (7.69 to 14.51)
Additional serotype 1	1.04 (0.71 to 1.54)	4.42 (2.93 to 6.67)
Additional serotype 3	1.3 (0.83 to 2.04)	2.12 (1.54 to 2.92)
Additional serotype 5	3.24 (2.45 to 4.27)	5.4 (4.08 to 7.15)
Additional serotype 6A	3.78 (2.85 to 5.03)	13.6 (9.01 to 20.53)
Additional serotype 7F	1.38 (0.93 to 2.05)	4.7 (3.26 to 6.78)
Additional serotype 19A	7.05 (5.52 to 8.99)	13.4 (10.3 to 17.42)

7vPnC serotype 4

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CIs for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[113]

Method

Parameter type

geometric mean fold rise

Point estimate

15.86

Confidence interval

level

95%

sides

2-sided

lower limit

9.16

upper limit

27.46

Notes
[113] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[114]

Method

Parameter type

geometric mean fold rise

Point estimate

5.01

Confidence interval

level

95%

sides

2-sided

lower limit

3.5

upper limit

7.16

Notes
[114] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[115]

Method

Parameter type

geometric mean fold rise

Point estimate

3.86

Confidence interval

level

95%

sides

2-sided

lower limit

2.93

upper limit

5.09

Notes
[115] - Descriptive

7vPnC serotype 14

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[116]

Method

Parameter type

geometric mean fold rise

Point estimate

17.57

Confidence interval

level

95%

sides

2-sided

lower limit

11.11

upper limit

27.79

Notes
[116] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[117]

Method

Parameter type

geometric mean fold rise

Point estimate

4.22

Confidence interval

level

95%

sides

2-sided

lower limit

2.86

upper limit

6.23

Notes
[117] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[118]

Method

Parameter type

geometric mean fold rise

Point estimate

2.54

Confidence interval

level

95%

sides

2-sided

lower limit

1.78

upper limit

3.62

Notes
[118] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[119]

Method

Parameter type

geometric mean fold rise

Point estimate

4.21

Confidence interval

level

95%

sides

2-sided

lower limit

2.86

upper limit

6.19

Notes
[119] - Descriptive

Additional serotype 3

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[120]

Method

Parameter type

geometric mean fold rise

Point estimate

1.63

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

2.05

Notes
[120] - Descriptive

Additional serotype 1

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[121]

Method

Parameter type

geometric mean fold rise

Point estimate

4.23

Confidence interval

level

95%

sides

2-sided

lower limit

2.79

upper limit

6.42

Notes
[121] - Descriptive

Additional serotype 5

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[122]

Method

Parameter type

geometric mean fold rise

Point estimate

1.67

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

2.14

Notes
[122] - Descriptive

Additional serotype 6A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[123]

Method

Parameter type

geometric mean fold rise

Point estimate

3.6

Confidence interval

level

95%

sides

2-sided

lower limit

2.39

upper limit

5.42

Notes
[123] - Descriptive

Additional serotype 7F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[124]

Method

Parameter type

geometric mean fold rise

Point estimate

3.41

Confidence interval

level

95%

sides

2-sided

lower limit

2.42

upper limit

4.82

Notes
[124] - Descriptive

Additional serotype 19A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[125]

Method

Parameter type

geometric mean fold rise

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

2.26

Notes
[125] - Descriptive

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Top of page

End point title

Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

End point description

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 7 (Visit 4)

End point values	MnCC / 13vPnC prevaccination Visit 1	MnCC / 13vPnC postvaccination Visit 4
Number of subjects analysed	35 ^[126]	35 ^[127]
Units: Mcg/mL
geometric mean (confidence interval 95%)
7vPnC serotype 4	0.15 (0.07 to 0.29)	1.21 (0.7 to 2.11)
7vPnC serotype 6B	3.97 (2.78 to 5.67)	9.42 (6.23 to 14.24)
7vPnC serotype 9V	1.69 (1.2 to 2.38)	3.41 (2.51 to 4.65)
7vPnC serotype 14	0.79 (0.43 to 1.43)	5.22 (2.76 to 9.86)
7vPnC serotype 18C	0.72 (0.46 to 1.13)	3.53 (2.16 to 5.76)
7vPnC serotype 19F	2.01 (1.32 to 3.05)	5.47 (3.51 to 8.54)
7vPnC serotype 23F	2.31 (1.7 to 3.14)	6.51 (4.24 to 10.01)
Additional serotype 1	0.7 (0.43 to 1.15)	2.65 (1.75 to 4)
Additional serotype 3	1.11 (0.67 to 1.82)	1.46 (0.97 to 2.2)
Additional serotype 5	3.83 (2.77 to 5.31)	5 (3.49 to 7.15)
Additional serotype 6A	3.82 (2.79 to 5.23)	7.79 (5.17 to 11.72)
Additional serotype 7F	1.12 (0.73 to 1.72)	3.21 (2.25 to 4.59)
Additional serotype 19A	6.18 (4.57 to 8.35)	12.03 (8.83 to 16.39)

Notes
[126] - Subjects with valid and determinate assay results for both pre and post vaccination blood draw.
[127] - Subjects with valid and determinate assay results for both pre and post vaccination blood draw.

7vPnC serotype 4

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[128]

Method

Parameter type

geometric mean fold rise

Point estimate

8.36

Confidence interval

level

95%

sides

2-sided

lower limit

4.5

upper limit

15.56

Notes
[128] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[129]

Method

Parameter type

geometric mean fold rise

Point estimate

2.37

Confidence interval

level

95%

sides

2-sided

lower limit

1.78

upper limit

3.16

Notes
[129] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[130]

Method

Parameter type

geometric mean fold rise

Point estimate

2.02

Confidence interval

level

95%

sides

2-sided

lower limit

1.63

upper limit

2.49

Notes
[130] - Descriptive

7vPnC serotype 14

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[131]

Method

Parameter type

geometric mean fold rise

Point estimate

6.61

Confidence interval

level

95%

sides

2-sided

lower limit

4.31

upper limit

10.15

Notes
[131] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[132]

Method

Parameter type

geometric mean fold rise

Point estimate

4.92

Confidence interval

level

95%

sides

2-sided

lower limit

3.34

upper limit

7.26

Notes
[132] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[133]

Method

Parameter type

geometric mean fold rise

Point estimate

2.73

Confidence interval

level

95%

sides

2-sided

lower limit

2.08

upper limit

3.57

Notes
[133] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[134]

Method

Parameter type

geometric mean fold rise

Point estimate

2.82

Confidence interval

level

95%

sides

2-sided

lower limit

2.08

upper limit

3.83

Notes
[134] - Descriptive

Additional serotype 1

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[135]

Method

Parameter type

geometric mean fold rise

Point estimate

3.79

Confidence interval

level

95%

sides

2-sided

lower limit

2.8

upper limit

5.13

Notes
[135] - Descriptive

Additional serotype 3

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[136]

Method

Parameter type

geometric mean fold rise

Point estimate

1.32

Confidence interval

level

95%

sides

2-sided

lower limit

1.11

upper limit

1.57

Notes
[136] - Descriptive

Additional serotype 5

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[137]

Method

Parameter type

geometric mean fold rise

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.05

upper limit

1.61

Notes
[137] - Descriptive

Additional serotype 6A

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[138]

Method

Parameter type

geometric mean fold rise

Point estimate

2.04

Confidence interval

level

95%

sides

2-sided

lower limit

1.51

upper limit

2.75

Notes
[138] - Descriptive

Additional serotype 7F

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[139]

Method

Parameter type

geometric mean fold rise

Point estimate

2.87

Confidence interval

level

95%

sides

2-sided

lower limit

2.19

upper limit

3.77

Notes
[139] - Descriptive

Additional serotype 19A

Statistical analysis description

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[140]

Method

Parameter type

geometric mean fold rise

Point estimate

1.95

Confidence interval

level

95%

sides

2-sided

lower limit

1.59

upper limit

2.39

Notes
[140] - Descriptive

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Top of page

End point title

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

End point description

Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. Evaluable Immunogenicity population. GMTs calculated using all subjects with available data at both the prevaccination and postvaccination blood draws.

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 28 (Visit 5)

End point values	7vPnC / 13vPnC prevaccination Visit 1	7vPnC / 13vPnC postvaccination Visit 5
Number of subjects analysed	38	38
Units: Titer
geometric mean (confidence interval 95%)
7vPnC serotype 4	22 (6.3 to 80.7)	4535 (2836.5 to 7251.3)
7vPnC serotype 6B	1024 (488.4 to 2148.4)	11939 (8748.1 to 16293.9)
7vPnC serotype 9V	43 (13.4 to 137.3)	6709 (5097.5 to 8829.4)
7vPnC serotype 14	159 (63.7 to 396)	5946 (4361.1 to 8107.6)
7vPnC serotype 18C	54 (19.5 to 149.5)	5067 (3375.1 to 7607.2)
7vPnC serotype 19F	33 (15.1 to 73.3)	1623 (995.2 to 2647.9)
7vPnC serotype 23F	87 (34.1 to 223.4)	2799 (2048.5 to 3823.2)
Additional serotype 1	6 (4.3 to 7.4)	440 (301.8 to 641.2)
Additional serotype 3	11 (6.9 to 16.6)	111 (87.1 to 141.1)
Additional serotype 5	4 (3.6 to 5.6)	277 (145.2 to 526.4)
Additional serotype 6A	17 (7.1 to 39.7)	9029 (6255 to 13034)
Additional serotype 7F	60 (17.7 to 205.3)	7036 (4886 to 10131.8)
Additional serotype 19A	76 (36.7 to 157.5)	1869 (1099.8 to 3177.3)

7vPnC serotype 4

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[141]

Method

Parameter type

geometric mean fold rise

Point estimate

201.8

Confidence interval

level

95%

sides

2-sided

lower limit

55.11

upper limit

739.05

Notes
[141] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[142]

Method

Parameter type

geometric mean fold rise

Point estimate

11.7

Confidence interval

level

95%

sides

2-sided

lower limit

5.2

upper limit

26.1

Notes
[142] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[143]

Method

Parameter type

geometric mean fold rise

Point estimate

156.4

Confidence interval

level

95%

sides

2-sided

lower limit

48.72

upper limit

501.86

Notes
[143] - Descriptive

7vPnC serotype 14

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[144]

Method

Parameter type

geometric mean fold rise

Point estimate

37.4

Confidence interval

level

95%

sides

2-sided

lower limit

13.71

upper limit

102.31

Notes
[144] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[145]

Method

Parameter type

geometric mean fold rise

Point estimate

93.9

Confidence interval

level

95%

sides

2-sided

lower limit

30.99

upper limit

284.31

Notes
[145] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[146]

Method

Parameter type

geometric mean fold rise

Point estimate

48.7

Confidence interval

level

95%

sides

2-sided

lower limit

23.27

upper limit

101.97

Notes
[146] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[147]

Method

Parameter type

geometric mean fold rise

Point estimate

32.1

Confidence interval

level

95%

sides

2-sided

lower limit

11.99

upper limit

85.81

Notes
[147] - Descriptive

Additional serotype 1

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[148]

Method

Parameter type

geometric mean fold rise

Point estimate

78.1

Confidence interval

level

95%

sides

2-sided

lower limit

50.42

upper limit

120.94

Notes
[148] - Descriptive

Additional serotype 3

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[149]

Method

Parameter type

geometric mean fold rise

Point estimate

10.3

Confidence interval

level

95%

sides

2-sided

lower limit

6.8

upper limit

15.72

Notes
[149] - Descriptive

Additional serotype 5

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[150]

Method

Parameter type

geometric mean fold rise

Point estimate

61.7

Confidence interval

level

95%

sides

2-sided

lower limit

32.75

upper limit

116.34

Notes
[150] - Descriptive

Additional serotype 6A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[151]

Method

Parameter type

geometric mean fold rise

Point estimate

536.5

Confidence interval

level

95%

sides

2-sided

lower limit

212.04

upper limit

1357.19

Notes
[151] - Descriptive

Additional serotype 7F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[152]

Method

Parameter type

geometric mean fold rise

Point estimate

116.9

Confidence interval

level

95%

sides

2-sided

lower limit

33.28

upper limit

410.33

Notes
[152] - Descriptive

Additional serotype 19A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[153]

Method

Parameter type

geometric mean fold rise

Point estimate

24.6

Confidence interval

level

95%

sides

2-sided

lower limit

11.3

upper limit

53.42

Notes
[153] - Descriptive

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Top of page

End point title

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

End point description

Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. Evaluable Immunogenicity population; GMTs calculated using all subjects with available data at both the prevaccination and postvaccination blood draws.

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 28 (Visit 5)

End point values	MnCC / 13vPnC prevaccination Visit 1	MnCC / 13vPnC postvaccination Visit 5
Number of subjects analysed	35 ^[154]	35 ^[155]
Units: Titer
geometric mean (confidence interval 95%)
7vPnC serotype 4	28 (4.5 to 174.3)	4704 (2958 to 7481.1)
7vPnC serotype 6B	288 (74.8 to 1106.9)	11607 (7762.6 to 17354.1)
7vPnC serotype 9V	120 (37.9 to 382.8)	7457 (5702.3 to 9751.9)
7vPnC serotype 14	262 (98.1 to 700.5)	7006 (4997.7 to 9822.1)
7vPnC serotype 18C	25 (8.4 to 75.7)	5736 (4141.4 to 7943.8)
7vPnC serotype 19F	23 (10.5 to 50.6)	2696 (1831 to 3968.5)
7vPnC serotype 23F	11 (5 to 23.5)	5197 (3599.2 to 7503.1)
Additional serotype 1	5 (4 to 6.6)	341 (221.9 to 524.9)
Additional serotype 3	11 (7 to 18.2)	98 (75.2 to 126.9)
Additional serotype 5	4 (3.7 to 5)	336 (175.4 to 642.2)
Additional serotype 6A	24 (8.9 to 64.2)	10488 (7460.6 to 14744.7)
Additional serotype 7F	76 (21.1 to 275.2)	6098 (4392.9 to 8464.9)
Additional serotype 19A	39 (19.9 to 78.1)	2424 (1696.6 to 3462.4)

Notes
[154] - Subjects with valid and determinate assay results for both the pre and post vaccination blood draw.
[155] - Subjects with valid and determinate assay results for both the pre and post vaccination blood draw.

7vPnC serotype 6B

Statistical analysis description

GMRFs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[156]

Method

Parameter type

geometric mean fold rise

Point estimate

40.3

Confidence interval

level

95%

sides

2-sided

lower limit

10.97

upper limit

148.44

Notes
[156] - Descriptive

7vPnC serotype 4

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[157]

Method

Parameter type

geometric mean fold rise

Point estimate

168.8

Confidence interval

level

95%

sides

2-sided

lower limit

20.22

upper limit

1409.76

Notes
[157] - Descriptive

7vPnC serotype 9V

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[158]

Method

Parameter type

geometric mean fold rise

Point estimate

61.9

Confidence interval

level

95%

sides

2-sided

lower limit

18.83

upper limit

203.72

Notes
[158] - Descriptive

7vPnC serotype 14

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[159]

Method

Parameter type

geometric mean fold rise

Point estimate

26.7

Confidence interval

level

95%

sides

2-sided

lower limit

9.67

upper limit

73.84

Notes
[159] - Descriptive

7vPnC serotype 19F

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[160]

Method

Parameter type

geometric mean fold rise

Point estimate

116.8

Confidence interval

level

95%

sides

2-sided

lower limit

54.54

upper limit

250.13

Notes
[160] - Descriptive

7vPnC serotype 18C

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[161]

Method

Parameter type

geometric mean fold rise

Point estimate

226.9

Confidence interval

level

95%

sides

2-sided

lower limit

79.81

upper limit

645.29

Notes
[161] - Descriptive

7vPnC serotype 23F

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[162]

Method

Parameter type

geometric mean fold rise

Point estimate

481

Confidence interval

level

95%

sides

2-sided

lower limit

207.01

upper limit

1117.69

Notes
[162] - Descriptive

Additional serotype 1

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[163]

Method

Parameter type

geometric mean fold rise

Point estimate

66.5

Confidence interval

level

95%

sides

2-sided

lower limit

41.8

upper limit

105.75

Notes
[163] - Descriptive

Additional serotype 3

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[164]

Method

Parameter type

geometric mean fold rise

Point estimate

8.6

Confidence interval

level

95%

sides

2-sided

lower limit

5.36

upper limit

13.94

Notes
[164] - Descriptive

Additional serotype 5

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[165]

Method

Parameter type

geometric mean fold rise

Point estimate

78.2

Confidence interval

level

95%

sides

2-sided

lower limit

41.38

upper limit

147.8

Notes
[165] - Descriptive

Additional serotype 6A

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[166]

Method

Parameter type

geometric mean fold rise

Point estimate

438.1

Confidence interval

level

95%

sides

2-sided

lower limit

169.52

upper limit

1132.43

Notes
[166] - Descriptive

Additional serotype 7F

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[167]

Method

Parameter type

geometric mean fold rise

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

23.28

upper limit

274.82

Notes
[167] - Descriptive

Additional serotype 19A

Statistical analysis description

GMFRs were calculated (postvaccination Visit 5 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 5

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[168]

Method

Parameter type

geometric mean fold rise

Point estimate

61.5

Confidence interval

level

95%

sides

2-sided

lower limit

28.73

upper limit

131.76

Notes
[168] - Descriptive

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Top of page

End point title

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

End point description

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 7 (Visit 4)

End point values	7vPnC / 13vPnC prevaccination Visit 1	7vPnC / 13vPnC postvaccination Visit 4
Number of subjects analysed	37 ^[169]	37 ^[170]
Units: Titer
geometric mean (confidence interval 95%)
7vPnC serotype 4	19 (6 to 62.8)	5449 (3118.6 to 9519.8)
7vPnC serotype 6B	1034 (505.1 to 2116.9)	7885 (5792 to 10734)
7vPnC serotype 9V	43 (13.4 to 137.3)	6497 (4357.4 to 9687.5)
7vPnC serotype 14	148 (58.2 to 375.7)	3497 (2440.8 to 5009.1)
7vPnC serotype 18C	58 (20.6 to 163.8)	5922 (3784 to 9268.9)
7vPnC serotype 19F	40 (17.4 to 91.6)	1243 (620.6 to 2489.8)
7vPnC serotype 23F	79 (31.4 to 201.3)	1487 (884.7 to 2499.5)
Additional serotype 1	6 (4.3 to 7.6)	367 (228.8 to 587.3)
Additional serotype 3	11 (6.9 to 16.6)	119 (82.1 to 172)
Additional serotype 5	4 (3.6 to 5.6)	185 (100.9 to 337.5)
Additional serotype 6A	17 (7.1 to 39.7)	8072 (5195.8 to 12538.8)
Additional serotype 7F	60 (17.7 to 205.3)	4601 (2998.3 to 7060.6)
Additional serotype 19A	76 (36.7 to 157.5)	1345 (767.4 to 2357.7)

Notes
[169] - Subjects with valid and determinate assay results for both the pre and post vaccination blood draw.
[170] - Subjects with valid and determinate assay results for both the pre and post vaccination blood draw.

7vPnC serotype 4

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[171]

Method

Parameter type

geometric mean fold rise

Point estimate

281.7

Confidence interval

level

95%

sides

2-sided

lower limit

76.65

upper limit

1035.49

Notes
[171] - Descriptive

7vPnC serotype 6B

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[172]

Method

Parameter type

geometric mean fold rise

Point estimate

7.6

Confidence interval

level

95%

sides

2-sided

lower limit

3.47

upper limit

16.75

Notes
[172] - Descriptive

7vPnC serotype 9V

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[173]

Method

Parameter type

geometric mean fold rise

Point estimate

151.4

Confidence interval

level

95%

sides

2-sided

lower limit

42.01

upper limit

545.84

Notes
[173] - Descriptive

7vPnC serotype 14

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[174]

Method

Parameter type

geometric mean fold rise

Point estimate

23.7

Confidence interval

level

95%

sides

2-sided

lower limit

8.67

upper limit

64.54

Notes
[174] - Descriptive

7vPnC serotype 18C

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[175]

Method

Parameter type

geometric mean fold rise

Point estimate

102.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

325.4

Notes
[175] - Descriptive

7vPnC serotype 19F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[176]

Method

Parameter type

geometric mean fold rise

Point estimate

31.1

Confidence interval

level

95%

sides

2-sided

lower limit

12.71

upper limit

76.13

Notes
[176] - Descriptive

7vPnC serotype 23F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[177]

Method

Parameter type

geometric mean fold rise

Point estimate

18.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.82

upper limit

51.39

Notes
[177] - Descriptive

Additional serotype 1

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[178]

Method

Parameter type

geometric mean fold rise

Point estimate

64.4

Confidence interval

level

95%

sides

2-sided

lower limit

37.33

upper limit

111.18

Notes
[178] - Descriptive

Additional serotype 3

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[179]

Method

Parameter type

geometric mean fold rise

Point estimate

11.1

Confidence interval

level

95%

sides

2-sided

lower limit

6.64

upper limit

18.52

Notes
[179] - Descriptive

Additional serotype 5

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[180]

Method

Parameter type

geometric mean fold rise

Point estimate

41.2

Confidence interval

level

95%

sides

2-sided

lower limit

23.09

upper limit

73.48

Notes
[180] - Descriptive

Additional serotype 6A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[181]

Method

Parameter type

geometric mean fold rise

Point estimate

479.6

Confidence interval

level

95%

sides

2-sided

lower limit

171.63

upper limit

1339.96

Notes
[181] - Descriptive

Additional serotype 7F

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[182]

Method

Parameter type

geometric mean fold rise

Point estimate

76.4

Confidence interval

level

95%

sides

2-sided

lower limit

21.63

upper limit

270.02

Notes
[182] - Descriptive

Additional serotype 19A

Statistical analysis description

Comparison groups

7vPnC / 13vPnC prevaccination Visit 1 v 7vPnC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[183]

Method

Parameter type

geometric mean fold rise

Point estimate

17.7

Confidence interval

level

95%

sides

2-sided

lower limit

7.61

upper limit

41.08

Notes
[183] - Descriptive

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Top of page

End point title

Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

End point description

End point type

Secondary

End point timeframe

Baseline (Visit 1), Day 7 (Visit 4)

End point values	MnCC / 13vPnC prevaccination Visit 1	MnCC / 13vPnC postvaccination Visit 4
Number of subjects analysed	34 ^[184]	34 ^[185]
Units: Titer
geometric mean (confidence interval 95%)
7vPnC serotype 4	40 (6.3 to 254)	6782 (3687.6 to 12471.3)
7vPnC serotype 6B	405 (103.5 to 1584.7)	7195 (4585.5 to 11289.8)
7vPnC serotype 9V	116 (36.8 to 364.9)	7855 (5532.9 to 11152.1)
7vPnC serotype 14	280 (103.1 to 760.7)	6209 (4253.9 to 9063.3)
7vPnC serotype 18C	25 (8.4 to 75.7)	5193 (3658.1 to 7372.3)
7vPnC serotype 19F	20 (9.4 to 44.7)	1855 (1055.8 to 3258.2)
7vPnC serotype 23F	11 (5 to 23.5)	991 (501.3 to 1959.3)
Additional serotype 1	5 (4 to 6.5)	385 (249.4 to 595.6)
Additional serotype 3	12 (7.2 to 19)	101 (72.2 to 141.1)
Additional serotype 5	4 (3.7 to 5)	258 (132.3 to 503.4)
Additional serotype 6A	23 (8.7 to 59.1)	6107 (4149.7 to 8987.5)
Additional serotype 7F	95 (24.7 to 363.8)	3577 (1774.8 to 7208.2)
Additional serotype 19A	39 (19.9 to 78.1)	1763 (1220.1 to 2547.6)

Notes
[184] - Number of subjects with a determinate OPA antibody titer to the serotypes.
[185] - Number of subjects with a determinate OPA antibody titer to the serotypes.

7vPnC serotype 4

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[186]

Method

Parameter type

geometric mean fold rise

Point estimate

170.2

Confidence interval

level

95%

sides

2-sided

lower limit

22.24

upper limit

1301.79

Notes
[186] - Descriptive

7vPnC serotype 6B

Statistical analysis description

GMRFs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[187]

Method

Parameter type

geometric mean fold rise

Point estimate

17.8

Confidence interval

level

95%

sides

2-sided

lower limit

5.27

upper limit

59.91

Notes
[187] - Descriptive

7vPnC serotype 9V

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[188]

Method

Parameter type

geometric mean fold rise

Point estimate

67.8

Confidence interval

level

95%

sides

2-sided

lower limit

18.45

upper limit

249.02

Notes
[188] - Descriptive

7vPnC serotype 14

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[189]

Method

Parameter type

geometric mean fold rise

Point estimate

22.2

Confidence interval

level

95%

sides

2-sided

lower limit

7.94

upper limit

61.88

Notes
[189] - Descriptive

7vPnC serotype 18C

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[190]

Method

Parameter type

geometric mean fold rise

Point estimate

205.5

Confidence interval

level

95%

sides

2-sided

lower limit

70.04

upper limit

602.78

Notes
[190] - Descriptive

7vPnC serotype 19F

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[191]

Method

Parameter type

geometric mean fold rise

Point estimate

90.5

Confidence interval

level

95%

sides

2-sided

lower limit

40.28

upper limit

203.27

Notes
[191] - Descriptive

7vPnC serotype 23F

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[192]

Method

Parameter type

geometric mean fold rise

Point estimate

91.7

Confidence interval

level

95%

sides

2-sided

lower limit

36.25

upper limit

232.13

Notes
[192] - Descriptive

Additional serotype 1

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[193]

Method

Parameter type

geometric mean fold rise

Point estimate

75.6

Confidence interval

level

95%

sides

2-sided

lower limit

47.32

upper limit

120.91

Notes
[193] - Descriptive

Additional serotype 3

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[194]

Method

Parameter type

geometric mean fold rise

Point estimate

8.7

Confidence interval

level

95%

sides

2-sided

lower limit

5.21

upper limit

14.4

Notes
[194] - Descriptive

Additional serotype 5

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[195]

Method

Parameter type

geometric mean fold rise

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

31.06

upper limit

115.92

Notes
[195] - Descriptive

Additional serotype 7F

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[196]

Method

Parameter type

geometric mean fold rise

Point estimate

37.7

Confidence interval

level

95%

sides

2-sided

lower limit

10.85

upper limit

131.09

Notes
[196] - Descriptive

Additional serotype 6A

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC postvaccination Visit 4 v MnCC / 13vPnC prevaccination Visit 1

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[197]

Method

Parameter type

geometric mean fold rise

Point estimate

269.8

Confidence interval

level

95%

sides

2-sided

lower limit

105.09

upper limit

692.6

Notes
[197] - Descriptive

Additional serotype 19A

Statistical analysis description

GMFRs were calculated (postvaccination Visit 4 / prevaccination Visit 1) using all subjects with available data from both the prevaccination and postvaccination blood draws. CI for the GMRFs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the mean fold rise.

Comparison groups

MnCC / 13vPnC prevaccination Visit 1 v MnCC / 13vPnC postvaccination Visit 4

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[198]

Method

Parameter type

geometric mean fold rise

Point estimate

44.8

Confidence interval

level

95%

sides

2-sided

lower limit

21.31

upper limit

94.01

Notes
[198] - Descriptive

Secondary: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

Top of page

End point title

Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

End point description

Pneumococcal IgG GMCs measured as Mcg/mL for the 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMCs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. Evaluable Immunogenicity population. GMCs were calculated using all subjects with available data for the specified blood draw.

End point type

Secondary

End point timeframe

Day 28 (Visit 5)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	35 ^[199]
Units: Mcg/mL
geometric mean (confidence interval 95%)
7vPnC serotype 4	5.73 (4.21 to 7.81)	2.92 (2.22 to 3.83)
7vPnC serotype 6B	66.72 (50.19 to 88.7)	22.62 (14.56 to 35.16)
7vPnC serotype 9V	8.72 (6.68 to 11.4)	4.7 (3.49 to 6.33)
7vPnC serotype 14	41.45 (27.72 to 61.97)	18.5 (10.1 to 33.9)
7vPnC serotype 18C	5.72 (4.18 to 7.82)	9.04 (5.98 to 13.68)
7vPnC serotype 19F	14.17 (9.54 to 21.07)	15.8 (10 to 24.96)
7vPnC serotype 23F	17.2 (12.44 to 23.77)	20.8 (13.07 to 33.08)
Additional serotype 1	9.55 (6.46 to 14.13)	5.63 (3.67 to 8.64)
Additional serotype 3	2.13 (1.58 to 2.87)	1.71 (1.2 to 2.44)
Additional serotype 5	6.8 (4.75 to 9.74)	7.52 (5.12 to 11.04)
Additional serotype 6A	29.11 (19.04 to 44.5)	16.08 (10.18 to 25.4)
Additional serotype 7F	9.92 (7.03 to 14.01)	5.75 (3.98 to 8.33)
Additional serotype 19A	21.29 (14.9 to 30.43)	20.17 (15.28 to 26.63)

Notes
[199] - Subjects with a determinate OPA antibody concentration for the serotypes.

7vPnC serotype 4

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[200]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.97

Confidence interval

level

95%

sides

2-sided

lower limit

1.31

upper limit

2.95

Notes
[200] - Descriptive

7vPnC serotype 6B

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[201]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

2.95

Confidence interval

level

95%

sides

2-sided

lower limit

1.78

upper limit

4.9

Notes
[201] - Descriptive

7vPnC serotype 9V

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[202]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.85

Confidence interval

level

95%

sides

2-sided

lower limit

1.25

upper limit

2.75

Notes
[202] - Descriptive

7vPnC serotype 14

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[203]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

2.24

Confidence interval

level

95%

sides

2-sided

lower limit

1.11

upper limit

4.53

Notes
[203] - Descriptive

7vPnC serotype 18C

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[204]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

1.05

Notes
[204] - Descriptive

7vPnC serotype 19F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[205]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.62

Notes
[205] - Descriptive

7vPnC serotype 23F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[206]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

0.83

Confidence interval

level

95%

sides

2-sided

lower limit

0.48

upper limit

1.43

Notes
[206] - Descriptive

Additional serotype 3

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[207]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.25

Confidence interval

level

95%

sides

2-sided

lower limit

0.79

upper limit

1.96

Notes
[207] - Descriptive

Additional serotype 1

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[208]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.96

upper limit

Notes
[208] - Descriptive

Additional serotype 5

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[209]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

1.52

Notes
[209] - Descriptive

Additional serotype 7F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[210]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.72

Confidence interval

level

95%

sides

2-sided

lower limit

1.05

upper limit

2.83

Notes
[210] - Descriptive

Additional serotype 6A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[211]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.81

Confidence interval

level

95%

sides

2-sided

lower limit

0.98

upper limit

3.34

Notes
[211] - Descriptive

Additional serotype 19A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[212]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.67

upper limit

1.66

Notes
[212] - Descriptive

Secondary: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

Top of page

End point title

Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

End point description

End point type

Secondary

End point timeframe

Day 7 (Visit 4)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	35 ^[213]
Units: Mcg/mL
geometric mean (confidence interval 95%)
7vPnC serotype 4	3 (2.07 to 4.35)	1.37 (0.9 to 2.1)
7vPnC serotype 6B	29.46 (20.74 to 41.86)	9.42 (6.23 to 14.24)
7vPnC serotype 9V	5.75 (4.4 to 7.51)	3.41 (2.51 to 4.65)
7vPnC serotype 14	10.25 (6.85 to 15.33)	5.22 (2.76 to 9.86)
7vPnC serotype 18C	3.09 (2.22 to 4.29)	3.45 (2.16 to 5.52)
7vPnC serotype 19F	7.66 (5.66 to 10.36)	4.85 (3.09 to 7.62)
7vPnC serotype 23F	10.56 (7.69 to 14.51)	6.51 (4.24 to 10.01)
Additional serotype 1	3.98 (2.82 to 5.62)	2.83 (1.86 to 4.32)
Additional serotype 3	2.02 (1.48 to 2.76)	1.4 (0.95 to 2.06)
Additional serotype 5	5.4 (4.08 to 7.15)	5.12 (3.6 to 7.28)
Additional serotype 6A	13.6 (9.01 to 20.53)	7.25 (4.75 to 11.06)
Additional serotype 7F	4.7 (3.26 to 6.78)	3.17 (2.24 to 4.48)
Additional serotype 19A	13.4 (10.3 to 17.42)	12.03 (8.83 to 16.39)

Notes
[213] - Subjects with a determinate OPA antibody concentration for the serotypes.

7vPnC serotype 4

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[214]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

2.18

Confidence interval

level

95%

sides

2-sided

lower limit

1.26

upper limit

3.79

Notes
[214] - Descriptive

7vPnC serotype 6B

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[215]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

3.13

Confidence interval

level

95%

sides

2-sided

lower limit

1.84

upper limit

5.32

Notes
[215] - Descriptive

7vPnC serotype 9V

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[216]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.68

Confidence interval

level

95%

sides

2-sided

lower limit

1.13

upper limit

2.51

Notes
[216] - Descriptive

7vPnC serotype 14

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[217]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.96

Confidence interval

level

95%

sides

2-sided

lower limit

0.95

upper limit

4.07

Notes
[217] - Descriptive

7vPnC serotype 19F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[218]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.58

Confidence interval

level

95%

sides

2-sided

lower limit

0.93

upper limit

2.66

Notes
[218] - Descriptive

7vPnC serotype 18C

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[219]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

1.56

Notes
[219] - Descriptive

7vPnC serotype 23F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[220]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.62

Confidence interval

level

95%

sides

2-sided

lower limit

0.97

upper limit

2.73

Notes
[220] - Descriptive

Additional serotype 1

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[221]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.41

Confidence interval

level

95%

sides

2-sided

lower limit

0.83

upper limit

2.39

Notes
[221] - Descriptive

Additional serotype 3

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[222]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.44

Confidence interval

level

95%

sides

2-sided

lower limit

0.89

upper limit

2.34

Notes
[222] - Descriptive

Additional serotype 5

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[223]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.06

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

1.64

Notes
[223] - Descriptive

7vPnC serotype 6A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[224]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.88

Confidence interval

level

95%

sides

2-sided

lower limit

1.05

upper limit

3.35

Notes
[224] - Descriptive

Additional serotype 7F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[225]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.48

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

2.44

Notes
[225] - Descriptive

Additional serotype 19A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[226]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

1.11

Confidence interval

level

95%

sides

2-sided

lower limit

0.75

upper limit

1.66

Notes
[226] - Descriptive

Secondary: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

Top of page

End point title

Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

End point description

Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. Evaluable Immunogenicity population. GMTs were calculated using all subjects with available data for the specified blood draw.

End point type

Secondary

End point timeframe

Day 28 (Visit 5)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	35 ^[227]
Units: Titer
geometric mean (confidence interval 95%)
7vPnC serotype 4	4626 (3322.5 to 6441.2)	6065 (4590.9 to 8012.5)
7vPnC serotype 6B	11451 (8290.4 to 15817.9)	10380 (7515.2 to 14336.9)
7vPnC serotype 9V	6346 (5152.2 to 7817.5)	7555 (5916.7 to 9646.8)
7vPnC serotype 14	5898 (4481 to 7762.1)	7031 (5195.6 to 9515.5)
7vPnC serotype 18C	5090 (3428.4 to 7557.7)	6005 (4389.3 to 8214.6)
7vPnC serotype 19F	1623 (995.2 to 2647.9)	2696 (1831 to 3968.5)
7vPnC serotype 23F	2752 (2074.6 to 3651.3)	4841 (3574.5 to 6555.1)
Additional serotype 1	449 (312.8 to 643.2)	347 (228.3 to 527.4)
Additional serotype 3	113 (89.2 to 143.5)	99 (77 to 126.3)
Additional serotype 5	296 (158.8 to 549.9)	336 (175.4 to 642.2)
Additional serotype 6A	9458 (6674.2 to 13404)	10842 (7904.9 to 14870.9)
Additional serotype 7F	6740 (4933.2 to 9207.7)	6050 (4515 to 8106.7)
Additional serotype 19A	2120 (1308 to 3435.3)	2340 (1667 to 3285.4)

Notes
[227] - Subjects with a determinate OPA antibody concentration for the serotypes.

7vPnC serotype 4

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[228]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.17

Notes
[228] - Descriptive

7vPnC serotype 6B

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[229]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

1.73

Notes
[229] - Descriptive

7vPnC serotype 9V

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[230]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.61

upper limit

1.15

Notes
[230] - Descriptive

7vPnC serotype 14

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[231]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.56

upper limit

1.25

Notes
[231] - Descriptive

7vPnC serotype 18C

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[232]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.51

upper limit

1.4

Notes
[232] - Descriptive

7vPnC serotype 19F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[233]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.32

upper limit

1.12

Notes
[233] - Descriptive

7vPnC serotype 23F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[234]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

0.85

Notes
[234] - Descriptive

Additional serotype 1

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[235]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.75

upper limit

2.22

Notes
[235] - Descriptive

Additional serotype 3

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[236]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.82

upper limit

1.61

Notes
[236] - Descriptive

Additional serotype 5

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[237]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.36

upper limit

2.13

Notes
[237] - Descriptive

Additional serotype 6A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[238]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.55

upper limit

1.39

Notes
[238] - Descriptive

Additional serotype 7F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[239]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.73

upper limit

1.7

Notes
[239] - Descriptive

Additional Serotype 19A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[240]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

1.63

Notes
[240] - Descriptive

Secondary: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

Top of page

End point title

Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

End point description

Antibody geometric mean titers as measured by opsonophagocytic activity (OPA) assay for 13 pneumococcal serotypes (7vPnC serotypes 4, 6B, 9V, 14, 18C, 19F, 23F and additional serotypes 1, 3, 5, 6A, 7F, and 19A). The 2-sided, 95% CIs for the GMTs were constructed by back transformation of the CIs for the mean of the logarithmically transformed assay results computed using the Student t distribution. Evaluable Immunogenicity population. GMTs were calculated using all subjects with available data for the specified blood draw.

End point type

Secondary

End point timeframe

Day 7 (Visit 4)

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	35 ^[241]
Units: Titer
geometric mean (confidence interval 95%)
7vPnC serotype 4	5567 (3202.5 to 9678.7)	8339 (6154.1 to 11299.5)
7vPnC serotype 6B	8082 (5743.5 to 11372.6)	6450 (4477.8 to 9290.2)
7vPnC serotype 9V	6865 (4826.7 to 9763.7)	7806 (5491.4 to 11095.6)
7vPnC serotype 14	3596 (2613 to 4948.5)	5994 (4246.9 to 8460.1)
7vPnC serotype 18C	5833 (3770.5 to 9023.7)	5266 (3779.3 to 7338.4)
7vPnC serotype 19F	1243 (620.6 to 2489.8)	1855 (1055.8 to 3258.2)
7vPnC serotype 23F	1575 (987.7 to 2511.7)	1141 (655.1 to 1986.8)
Additional serotype 1	379 (241.8 to 594.9)	393 (257.2 to 600.3)
Additional serotype 3	117 (81.3 to 167.5)	104 (75.4 to 143.4)
Additional serotype 5	200 (111.2 to 358.6)	258 (132.3 to 503.4)
Additional serotype 6A	8534 (5631.9 to 12931.6)	6199 (4357.6 to 8818.6)
Additional serotype 7F	4750 (3291.8 to 6852.9)	3760 (2106.7 to 6709.5)
Additional serotype 19A	1504 (911.2 to 2484.1)	1761 (1242.8 to 2496)

Notes
[241] - Subjects with a determinate OPA antibody concentration for the serotypes.

7vPnC serotype 6B

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[242]

Method

Parameter type

Ratio of geometric mean concentrations

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.77

upper limit

2.05

Notes
[242] - Descriptive

7vPnC serotype 4

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[243]

Method

Parameter type

ratio of geometric mean concentrations

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.35

upper limit

1.27

Notes
[243] - Descriptive

7vPnC serotype 9V

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[244]

Method

Parameter type

Ratio of geometric mean concentrations

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.54

upper limit

1.44

Notes
[244] - Descriptive

7vPnC serotype 14

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[245]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.38

upper limit

0.95

Notes
[245] - Descriptive

7vPnC serotype 18C

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[246]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

1.91

Notes
[246] - Descriptive

7vPnC serotype 19F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[247]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.28

upper limit

1.62

Notes
[247] - Descriptive

7vPnC serotype 23F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[248]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.68

upper limit

2.81

Notes
[248] - Descriptive

Additional serotype 1

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[249]

Method

Parameter type

ratio of geometric mean titers

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.53

upper limit

1.77

Notes
[249] - Descriptive

Additional serotype 3

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[250]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

0.69

upper limit

1.81

Notes
[250] - Descriptive

Additional serotype 5

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[251]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.32

upper limit

1.85

Notes
[251] - Descriptive

Additional serotype 6A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[252]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.8

upper limit

2.36

Notes
[252] - Descriptive

Additional serotype 7F

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[253]

Method

Parameter type

ratio of geometric mean titers

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

2.44

Notes
[253] - Descriptive

Additional serotype 19A

Statistical analysis description

CIs for the ratio were back transformations of a CI based on the Student t distribution for the mean difference of the logarithms of the measures [(7vPnC/13vPnC) – (MnCC/13vPnC)].

Comparison groups

7vPnC / 13vPnC v MnCC / 13vPnC

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[254]

Method

Parameter type

ratio of geometric mean titers

Point estimate

0.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.46

upper limit

1.57

Notes
[254] - Descriptive

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 4 Days After Vaccination

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End point title

Percentage of Subjects Reporting Pre-Specified Local Reactions Within 4 Days After Vaccination

End point description

Local reactions reported using the diary card during the 4-day reactogenicity period after vaccination. Tenderness at injection site scaled as Any (tenderness present) or Significant (present and interfered with limb movement). Redness and swelling at injection site scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); or Severe (greater than [>] 7.0 cm). Subjects may be represented in >1 category. Safety population included all subjects who received the vaccine.

End point type

Other pre-specified

End point timeframe

Baseline up to 4 days after vaccination on Day 1

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	36 ^[255]
Units: percentage of subjects
number (not applicable)
Tenderness: Any	92.1	86.1
Tenderness: Significant	10.5	19.4
Swelling: Any	10.5	5.6
Swelling: Mild	2.6	2.8
Swelling: Moderate	10.5	2.8
Redness: Any	5.3	5.6
Redness: Mild	0	2.8
Redness: Moderate	5.3	2.8

Notes
[255] - Subjects with analyzable data for reactogenicity (reported Yes for at least 1 day or No for all days

No statistical analyses for this end point

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events Within 4 Days After Vaccination

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End point title

Percentage of Subjects Reporting Pre-Specified Systemic Events Within 4 Days After Vaccination

End point description

Systemic events reported using the diary card during the 4-day reactogenicity period after vaccination. Temperature scaled as Fever ≥38 but less than or equal to (≤) 39 degrees Celsius (C) (mild), >39 but ≤40 degrees C (moderate), or >40 degrees C (severe). Presence of Decreased appetite, Irritability, Increased sleep, Decreased sleep, Rash, and Hives; also scaled as Mild (easily tolerated, minimal discomfort; not interfering with activities), Moderate (sufficiently discomforting to interfere with normal activities), or Severe (may prevent normal activities and require medical intervention). Safety population.

End point type

Other pre-specified

End point timeframe

Baseline up to 4 days after vaccination on Day 1

End point values	7vPnC / 13vPnC	MnCC / 13vPnC
Number of subjects analysed	38	36 ^[256]
Units: percentage of subjects
number (not applicable)
Fever ≥38 but ≤39 degrees C	2.9	0
Decreased appetite	7.9	16.7
Decreased appetite: Mild	7.9	11.1
Decreased appetite: Moderate	2.6	8.3
Irritability	18.4	13.9
Irritability: Mild	13.2	11.1
Irritability: Moderate	5.3	5.6
Increased sleep	26.3	33.3
Increased sleep: Mild	15.8	25
Increased sleep: Moderate	13.2	13.9
Increased sleep: Severe	2.6	0
Decreased sleep	7.9	11.1
Decreased sleep: Mild	5.3	8.3
Decreased sleep: Moderate	2.6	2.8
Rash	5.3	0
Rash: Mild	5.3	0

Notes
[256] - Subjects with analyzable data for reactogenicity(reported Yes for at least 1 day or No for all days)

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to Day 4 after vaccination for local reactions (LR) and systemic events (SE) or up to Day 194 (Visit 6 / Days 166 to 194 Follow-up Telephone Visit to assess adverse events [AEs])

Adverse event reporting additional description

The same event may appear as both an AE and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 subject and as nonserious in another subject, or 1 subject may have experienced both a serious and nonserious event during the study.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

17.1

Reporting group title

7vPnC / 13vPnC

Reporting group description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received 7vPnC in study D118-P8. Adverse Events include Local reactions (LR) and Systemic events (SE) collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods). Other Adverse Events N=22; Local reactions N=38; Systemic events N=38.

Reporting group title

MnCC / 13vPnC

Reporting group description

13vPnC administered as a single 0.5 mL dose IM. Subjects had previously received MnCC in study D118-P8. Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods). Other Adverse Events N=20; Local reactions N=36; Systemic events N=36.

Serious adverse events	7vPnC / 13vPnC	MnCC / 13vPnC
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 38 (0.00%)	0 / 36 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0

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

Non-serious adverse events	7vPnC / 13vPnC	MnCC / 13vPnC
Total subjects affected by non serious adverse events
subjects affected / exposed	38 / 38 (100.00%)	36 / 36 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
Injection site pain
subjects affected / exposed	4 / 38 (10.53%)	4 / 36 (11.11%)
occurrences all number	5	4
Pyrexia
subjects affected / exposed	3 / 38 (7.89%)	1 / 36 (2.78%)
occurrences all number	3	1
Injection site swelling
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Fever >=38 degrees C but <=39 degrees
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Decreased appetite (LR)
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	3 / 38 (7.89%)	6 / 36 (16.67%)
occurrences all number	3	6
Decreased appetite: Mild
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	3 / 38 (7.89%)	4 / 36 (11.11%)
occurrences all number	3	4
Decreased appetite: Moderate
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	1 / 38 (2.63%)	3 / 36 (8.33%)
occurrences all number	1	3
Irritability
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	7 / 38 (18.42%)	5 / 36 (13.89%)
occurrences all number	7	5
Irritability: Mild
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	5 / 38 (13.16%)	4 / 36 (11.11%)
occurrences all number	5	4
Irritability: Moderate
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	2 / 38 (5.26%)	2 / 36 (5.56%)
occurrences all number	2	2
Increased sleep
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	10 / 38 (26.32%)	12 / 36 (33.33%)
occurrences all number	10	12
Increased sleep: Mild
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	6 / 38 (15.79%)	9 / 36 (25.00%)
occurrences all number	6	9
Increased sleep: Moderate
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	5 / 38 (13.16%)	5 / 36 (13.89%)
occurrences all number	5	5
Increased sleep: Severe
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Decreased sleep
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	3 / 38 (7.89%)	4 / 36 (11.11%)
occurrences all number	3	4
Decreased sleep: Mild
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	2 / 38 (5.26%)	3 / 36 (8.33%)
occurrences all number	2	3
Decreased sleep: Moderate
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	1 / 38 (2.63%)	1 / 36 (2.78%)
occurrences all number	1	1
Rash
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	2 / 38 (5.26%)	0 / 36 (0.00%)
occurrences all number	2	0
Rash: Mild
Additional description: Subjects affected and occurrences for LRs and 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 Events 0.0
alternative assessment type: Systematic
subjects affected / exposed	2 / 38 (5.26%)	0 / 36 (0.00%)
occurrences all number	2	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Gynaecomastia
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	4 / 38 (10.53%)	1 / 36 (2.78%)
occurrences all number	4	1
Oropharyngeal pain
subjects affected / exposed	3 / 38 (7.89%)	1 / 36 (2.78%)
occurrences all number	3	1
Rhinitis allergic
subjects affected / exposed	1 / 38 (2.63%)	2 / 36 (5.56%)
occurrences all number	1	2
Cough
subjects affected / exposed	1 / 38 (2.63%)	1 / 36 (2.78%)
occurrences all number	1	1
Nasal congestion
subjects affected / exposed	1 / 38 (2.63%)	1 / 36 (2.78%)
occurrences all number	1	1
Respiratory disorder
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	0 / 38 (0.00%)	2 / 36 (5.56%)
occurrences all number	0	2
Joint sprain
subjects affected / exposed	2 / 38 (5.26%)	0 / 36 (0.00%)
occurrences all number	2	0
Ankle fracture
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Avulsion fracture
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Clavicle fracture
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Concussion
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Excoriation
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	2
Hand fracture
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Muscle strain
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Traumatic brain injury
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Congenital, familial and genetic disorders
Congenital flat feet
subjects affected / exposed	0 / 38 (0.00%)	2 / 36 (5.56%)
occurrences all number	0	2
Cardiac disorders
Palpitations
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Nervous system disorders
Headache
subjects affected / exposed	2 / 38 (5.26%)	3 / 36 (8.33%)
occurrences all number	2	3
Hypersomnia
subjects affected / exposed	1 / 38 (2.63%)	2 / 36 (5.56%)
occurrences all number	3	2
Somnolence
subjects affected / exposed	0 / 38 (0.00%)	2 / 36 (5.56%)
occurrences all number	0	2
Dizziness
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Presyncope
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Syncope
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Blood and lymphatic system disorders
Lymphoid tissue hyperplasia
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Ear and labyrinth disorders
Cerumen impaction
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Ear congestion
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Ear pain
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Vomiting
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Skin and subcutaneous tissue disorders
Acne
subjects affected / exposed	2 / 38 (5.26%)	1 / 36 (2.78%)
occurrences all number	2	1
Dermatitis contact
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Ingrowing nail
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Tenderness: Any
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	35 / 38 (92.11%)	31 / 36 (86.11%)
occurrences all number	35	31
Tenderness: Significant
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	4 / 38 (10.53%)	7 / 36 (19.44%)
occurrences all number	4	7
Swelling: Any
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	4 / 38 (10.53%)	2 / 36 (5.56%)
occurrences all number	4	2
Swelling: Mild
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	1 / 38 (2.63%)	1 / 36 (2.78%)
occurrences all number	1	1
Swelling: Moderate
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	4 / 38 (10.53%)	1 / 36 (2.78%)
occurrences all number	4	1
Redness: Any
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	2 / 38 (5.26%)	2 / 36 (5.56%)
occurrences all number	2	2
Redness: Mild
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Redness: Moderate
Additional description: Subjects affected and occurrences for LRs and 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: Local Reactions 0.0
alternative assessment type: Systematic
subjects affected / exposed	2 / 38 (5.26%)	1 / 36 (2.78%)
occurrences all number	2	1
Renal and urinary disorders
Haematuria
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Patellofemoral pain syndrome
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Infections and infestations
Otitis externa
subjects affected / exposed	1 / 38 (2.63%)	2 / 36 (5.56%)
occurrences all number	1	2
Pharyngitis
subjects affected / exposed	2 / 38 (5.26%)	0 / 36 (0.00%)
occurrences all number	2	0
Acute sinusitis
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Bronchitis
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Gastritis viral
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Pneumonia
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Sinusitis
subjects affected / exposed	0 / 38 (0.00%)	1 / 36 (2.78%)
occurrences all number	0	1
Upper respiratory tract infection
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Viral upper respiratory tract infection
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 38 (0.00%)	2 / 36 (5.56%)
occurrences all number	0	2
Dehydration
subjects affected / exposed	1 / 38 (2.63%)	0 / 36 (0.00%)
occurrences all number	1	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

07 Aug 2009

Changed the study phase from 3 to 2, modified assessments at study visits, changed the duration of the study and of subject participation, the collection period for AEs was modified, clarified the administration of prohibited vaccines during the study and added categorizing criteria for systemic events.

30 Oct 2009

Removed the measurement of the activity of B-cells, and modified safety assessments at baseline, visit 4 and visit 6.

24 Feb 2010

Modified the definition of evaluable subjects and modified the assessments at baseline.

29 Mar 2010

Added the physical examinations to the study procedures.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Characterization of the Prevnar Infant Long-Term Immune Response Versus a Prevnar-Naive Cohort

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration Greater Than or Equal to (≥) 0.35 Microgram per Milliliter (mcg/mL) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Primary: Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration Greater Than or Equal to (≥) 0.35 Microgram per Milliliter (mcg/mL) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Primary: Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Primary: Percentage of Subjects Achieving a Pneumococcal IgG Antibody Concentration ≥0.35 Mcg/mL for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥Lower Limit of Quantification (LLOQ) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥Lower Limit of Quantification (LLOQ) for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥LLOQ for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 5)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Primary: Percentage of Subjects Achieving a Pneumococcal Opsonophagocytic Activity (OPA) Antibody Titer ≥1:8 for the 13 Serotypes for 7vPnC / 13vPnC in Comparison to MnCC / 13vPnC After Vaccination (Visit 4)

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 5

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to 7vPnC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Pneumococcal Opsonophagocytic Activity (OPA) Assay Geometric Mean Titers (GMTs) for the 13 Serotypes Relative to MnCC / 13vPnC Prevaccination Visit 1 and Postvaccination Visit 4

Secondary: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

Secondary: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

Secondary: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

Secondary: Comparison of Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

Secondary: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

Secondary: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 5)

Secondary: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

Secondary: Comparison of Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the 13 Serotypes for 7vPnC / 13vPnC Relative to MnCC / 13vPnC After Vaccination (Visit 4)

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 4 Days After Vaccination

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Local Reactions Within 4 Days After Vaccination

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events Within 4 Days After Vaccination

Other pre-specified: Percentage of Subjects Reporting Pre-Specified Systemic Events Within 4 Days After Vaccination

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
Characterization of the Prevnar Infant Long-Term Immune Response Versus a Prevnar-Naive Cohort