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    Clinical Trial Results:
    Revaccination with Pneumococcal Conjugate Vaccine - Characterization of the Immune Response after Polysaccharide (REPLAY)

    Summary
    EudraCT number
    		 2008-006194-33
    Trial protocol
    		 IS  
    Global end of trial date
    16 Dec 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jun 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    6096A1-3013
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00853749
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B1851012
    Sponsors
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Nov 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To characterize the immune response by enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic assay (OPA) at approximately one month after vaccination to a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC) challenge in children vaccinated with a primary series (3 or 2 doses) of pneumococcal conjugate vaccine (PCV) followed by a booster dose of either PCV or 23-valent pneumococcal polysaccharide vaccine (23vPS).
    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
    05 May 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Iceland: 89
    Worldwide total number of subjects
    89
    EEA total number of subjects
    89
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    89
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Total 89 subjects were enrolled in a single site in Iceland. Study was started on 05 May 2009 and completed on 16 Dec 2009.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PCV/23vPS/13vPnC
    Arm description
    		 For this study, subjects received a single dose of 13vPnC. Subject previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as PCV followed by a toddler dose of 23vPS.
    Arm type
    		 Experimental

    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 received a single dose 0.5 milliliter (mL) 13vPnC.

    Arm title
    		 PCV/PCV/13vPnC
    Arm description
    		 For this study, subjects received a single dose of 13vPnC. Subjects must have also previously received an infant series of 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
    Arm type
    		 Experimental

    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 received a single dose of 0.5 mL 13vPnC.

    Number of subjects in period 1
    		PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Started
    50
    39
    Vaccinated
    50
    39
    Completed
    50
    38
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PCV/23vPS/13vPnC
    Reporting group description
    		 For this study, subjects received a single dose of 13vPnC. Subject previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as PCV followed by a toddler dose of 23vPS.

    Reporting group title
    PCV/PCV/13vPnC
    Reporting group description
    		 For this study, subjects received a single dose of 13vPnC. Subjects must have also previously received an infant series of 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).

    Reporting group values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC Total
    Number of subjects
    		 50 39 89
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.6 ( 0.2 ) 7.6 ( 0.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 25 20 45
        Male
    		 25 19 44

    End points

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    End points reporting groups
    Reporting group title
    PCV/23vPS/13vPnC
    Reporting group description
    		 For this study, subjects received a single dose of 13vPnC. Subject previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as PCV followed by a toddler dose of 23vPS.

    Reporting group title
    PCV/PCV/13vPnC
    Reporting group description
    		 For this study, subjects received a single dose of 13vPnC. Subjects must have also previously received an infant series of 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).

    Primary: Percentage of Subjects Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination

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    End point title
    		 Percentage of Subjects Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination
    End point description
    Percentage of subjects achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) Confidence Interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable Immunogenicity Population: received 1 dose of 13vPnC at Visit 1, blood drawn within specified timeframes, at least 1 valid and determinate assay result at Visits 1 and 3, no major protocol violations, and no prohibited vaccines.
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Number of subjects analysed
    50 [1]
    37 [2]
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotype 4
    100 (92.9 to 100)
    97.3 (85.8 to 99.9)
        Common Serotype 6B
    100 (92.9 to 100)
    100 (90.5 to 100)
        Common Serotype 9V
    100 (92.9 to 100)
    100 (90.5 to 100)
        Common Serotype 14
    100 (92.7 to 100)
    100 (90.5 to 100)
        Common Serotype18C
    100 (92.9 to 100)
    97.3 (85.8 to 99.9)
        Common Serotype 19F
    100 (92.9 to 100)
    100 (90.5 to 100)
        Common Serotype 23F
    100 (92.9 to 100)
    100 (90.5 to 100)
        Additional Serotype 1
    100 (92.9 to 100)
    97.3 (85.8 to 99.9)
        Additional Serotype 3
    100 (92.9 to 100)
    100 (90.5 to 100)
        Additional Serotype 5
    100 (92.9 to 100)
    100 (90.5 to 100)
        Additional Serotype 6A
    100 (92.9 to 100)
    100 (90.5 to 100)
        Additional Serotype 7F
    100 (92.9 to 100)
    100 (90.5 to 100)
        Additional Serotype 19A
    100 (92.9 to 100)
    100 (90.5 to 100)
    Notes
    [1] - N= Number of subjects with a determinate IgG antibody concentration to the given serotype.
    [2] - N= Number of subjects with a determinate IgG antibody concentration to the given serotype.
    Statistical analysis title
    		 Comparison for Common Serotype 4
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 14.2
    Statistical analysis title
    		 Comparison for Common Serotype 6B
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Common Serotype 9V
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Common Serotype 14
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.8
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Common Serotype 18C
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 14.2
    Statistical analysis title
    		 Comparison for Common Serotype 19F
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Common Serotype 23F
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Additional Serotype 1
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 14.2
    Statistical analysis title
    		 Comparison for Additional Serotype 3
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Additional Serotype 5
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Additional Serotype 6A
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Additional Serotype 7F
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Additional Serotype 19A
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5

    Primary: Percentage of Subjects Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination

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    End point title
    		 Percentage of Subjects Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination
    End point description
    Percentage of subjects achieving OPA along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of subjects. Evaluable immunogenicity population.
    End point type
    Primary
    End point timeframe
    Day 28
    End point values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Number of subjects analysed
    50 [3]
    37 [4]
    Units: percentage of subjects
    number (confidence interval 95%)
        Common Serotype 4
    98 (89.4 to 99.9)
    97.2 (85.5 to 99.9)
        Common Serotype 6B
    100 (92.7 to 100)
    100 (90.3 to 100)
        Common Serotype 9V
    100 (92.7 to 100)
    100 (90.3 to 100)
        Common Serotype 14
    100 (92.7 to 100)
    100 (90.3 to 100)
        Common Serotype 18C
    100 (92.9 to 100)
    100 (90 to 100)
        Common Serotype 19F
    100 (92.7 to 100)
    100 (90 to 100)
        Common Serotype 23F
    98 (89.4 to 99.9)
    100 (89.7 to 100)
        Additional Serotype 1
    100 (92.9 to 100)
    97.3 (85.8 to 99.9)
        Additional Serotype 3
    98 (89.1 to 99.9)
    100 (90.3 to 100)
        Additional Serotype 5
    98 (89.4 to 99.9)
    97.3 (85.8 to 99.9)
        Additional Serotype 6A
    100 (92.9 to 100)
    100 (90.5 to 100)
        Additional Serotype 7F
    98 (89.4 to 99.9)
    100 (90.3 to 100)
        Additional Serotype 19A
    100 (92.9 to 100)
    100 (90.5 to 100)
    Notes
    [3] - N=number of subjects with a determinate OPA antibody titer to the given serotype.
    [4] - N=number of subjects with a determinate OPA antibody titer to the given serotype.
    Statistical analysis title
    		 Comparison for Common Serotype 4
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 12.7
    Statistical analysis title
    		 Comparison for Common Serotype 6B
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 9.7
    Statistical analysis title
    		 Comparison for Common Serotype 9V
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 9.7
    Statistical analysis title
    		 Comparison for Common Serotype 14
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 9.7
    Statistical analysis title
    		 Comparison for Common Serotype 18C
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.4
         upper limit
    		 10
    Statistical analysis title
    		 Comparison for Common Serotype 19F
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.5
         upper limit
    		 10
    Statistical analysis title
    		 Comparison for Common Serotype 23F
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 8.1
    Statistical analysis title
    		 Comparison for Additional Serotype 1
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 14.2
    Statistical analysis title
    		 Comparison for Additional Serotype 3
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.1
         upper limit
    		 7.9
    Statistical analysis title
    		 Comparison for Additional Serotype 5
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 12.2
    Statistical analysis title
    		 Comparison for Additional Serotype 6A
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5
    Statistical analysis title
    		 Comparison for Additional Serotype 7F
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.3
         upper limit
    		 7.7
    Statistical analysis title
    		 Comparison for Additional Serotype 19A
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportions (percentage)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.3
         upper limit
    		 9.5

    Secondary: Antibody Response Measured 1 Month After Vaccination (Avidity Assay)

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    End point title
    		 Antibody Response Measured 1 Month After Vaccination (Avidity Assay)
    End point description
    Avidity assay had measurable range of 0.117 to 7.5. Results expressed as Avidity Index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5). Evaluable imunogenicity population; in accordance with the recommendation of the lab completing the assays, values above the upper limit were assigned a value of 8.0 and those below the lower limit were assigned a value of 0.10.
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Number of subjects analysed
    50 [5]
    36 [6]
    Units: AI
    geometric mean (confidence interval 95%)
        Additional serotype 1
    1.42 (1.15 to 1.76)
    4.68 (3.62 to 6.04)
        Additional serotype 5
    1.85 (1.46 to 2.36)
    5.85 (4.81 to 7.11)
        Common serotype 6B
    2.43 (1.77 to 3.35)
    5.48 (4.38 to 6.86)
        Common serotype 19F
    2.17 (1.69 to 2.79)
    2.46 (1.88 to 3.21)
        Common serotype 23F
    3.02 (2.36 to 3.85)
    6.43 (5.33 to 7.76)
    Notes
    [5] - N=number of subjects with a determinate avidity index for the specified serotype.
    [6] - N=number of subjects with a determinate avidity index for the specified serotype.
    Statistical analysis title
    		 Serotype 1
    Statistical analysis description
    Confidence Intervals (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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.22
         upper limit
    		 0.42
    Statistical analysis title
    		 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.23
         upper limit
    		 0.44
    Statistical analysis title
    		 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 0.67
    Statistical analysis title
    		 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.27
    Statistical analysis title
    		 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.34
         upper limit
    		 0.65

    Secondary: Antibody Response Measured 1 Month After Vaccination (OPA)

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    End point title
    		 Antibody Response Measured 1 Month After Vaccination (OPA)
    End point description
    Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all subjects with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Evaluable immunogenicity population.
    End point type
    Secondary
    End point timeframe
    Day 28
    End point values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Number of subjects analysed
    50 [7]
    37 [8]
    Units: GMT
    geometric mean (confidence interval 95%)
        Common Serotype 4
    2374 (1656.3 to 3404)
    3765 (2339.1 to 6059.8)
        Common Serotype 6B
    11156 (9073.5 to 13715.2)
    11477 (8418.5 to 15646.8)
        Common Serotype 9V
    1651 (1067.8 to 2553.3)
    1713 (1087 to 2700)
        Common Serotype 14
    3041 (2311.4 to 4001.1)
    3048 (2318.3 to 4006.9)
        Common Serotype 18C
    3230 (2616.1 to 3987.1)
    5684 (3122.2 to 10349.6)
        Common Serotype 19F
    1266 (1013.9 to 1582)
    1198 (842.3 to 1703.9)
        Common Serotype 23F
    1678 (1212.3 to 2322.1)
    2714 (1970.1 to 3739.5)
        Additional Serotype 1
    217 (162.6 to 290.5)
    1087 (717.5 to 1646.3)
        Additional Serotype 3
    153 (117.2 to 200.2)
    188 (146.6 to 240.8)
        Additional Serotype 5
    264 (178.5 to 389.9)
    719 (500.9 to 1032.4)
        Additional Serotype 6A
    7060 (5352.2 to 9312.6)
    5034 (3336.6 to 7594.4)
        Additional Serotype 7F
    5835 (4160 to 8184.1)
    7887 (6447.9 to 9647)
        Additional Serotype 19A
    1256 (990.9 to 1591.9)
    1556 (1108.8 to 2182.2)
    Notes
    [7] - N=number of subjects with a determinate antibody titre to the specified serotype.
    [8] - N=number of subjects with a determinate antibody titre to the specified serotype.
    Statistical analysis title
    		 Common Serotype 4
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.12
    Statistical analysis title
    		 Common Serotype 6B
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/PCV/13vPnC v PCV/23vPS/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.38
    Statistical analysis title
    		 Common Serotype 9V
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.81
    Statistical analysis title
    		 Common Serotype 14
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.48
    Statistical analysis title
    		 Common Serotype 18C
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 0.98
    Statistical analysis title
    		 Common Serotype 19F
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.56
    Statistical analysis title
    		 Common Serotype 23F
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 0.99
    Statistical analysis title
    		 Additional Serotype 1
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.12
         upper limit
    		 0.32
    Statistical analysis title
    		 Additional Serotype 3
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.18
    Statistical analysis title
    		 Additional Serotype 5
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.21
         upper limit
    		 0.63
    Statistical analysis title
    		 Additional Serotype 6A
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/PCV/13vPnC v PCV/23vPS/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 2.25
    Statistical analysis title
    		 Additional Serotype 7F
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.14
    Statistical analysis title
    		 Additional Serotype 19A
    Statistical analysis description
    Ratio of GMTs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMTs
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.2

    Other pre-specified: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination

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    End point title
    		 Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody 1 Month After Vaccination
    End point description
    Antibody GMC as measured by mcg/mL for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations. GMCs were calculated using all subjects with available data for the specified blood draw. Evaluable Immunogenicity Population.
    End point type
    Other pre-specified
    End point timeframe
    Day 28
    End point values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Number of subjects analysed
    50 [9]
    37 [10]
    Units: mcg/mL
    geometric mean (confidence interval 95%)
        Common serotype 4
    4.18 (3.38 to 5.16)
    11.34 (7.74 to 16.62)
        Common serotype 6B
    29.51 (21.32 to 40.83)
    41.7 (29.01 to 59.96)
        Common serotype 9V
    4.31 (3.68 to 5.04)
    7.39 (6.05 to 9.03)
        Common serotype 14
    17.47 (12.76 to 23.93)
    22.78 (15.75 to 32.96)
        Common serotype 18C
    2.76 (2.15 to 3.56)
    4.83 (3.48 to 6.71)
        Common serotype 19F
    9.78 (7.45 to 12.83)
    11.6 (8.46 to 15.92)
        Common serotype 23F
    7.89 (6.18 to 10.07)
    12.25 (8.92 to 16.81)
        Additional serotype 1
    5.28 (4.22 to 6.61)
    19.43 (13.77 to 27.41)
        Additional serotype 3
    3.28 (2.44 to 4.41)
    2.87 (2.19 to 3.76)
        Additional serotype 5
    5.75 (4.64 to 7.12)
    15.98 (11.99 to 21.3)
        Additional serotype 6A
    11.16 (8.8 to 14.16)
    14.07 (10.64 to 18.61)
        Additional serotype 7F
    7.13 (5.67 to 8.96)
    8.05 (5.94 to 10.91)
        Additional serotype 19A
    14.62 (11.49 to 18.59)
    17.07 (12.92 to 22.55)
    Notes
    [9] - N=number of subjects with a determinate antibody concentration to the specified serotype.
    [10] - N=number of subjects with a determinate antibody concentration to the specified serotype.
    Statistical analysis title
    		 Common Serotype 4
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.55
    Statistical analysis title
    		 Common Serotype 6B
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.15
    Statistical analysis title
    		 Common Serotype 9V
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.45
         upper limit
    		 0.75
    Statistical analysis title
    		 Common Serotype 14
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.24
    Statistical analysis title
    		 Common Serotype 18C
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.38
         upper limit
    		 0.85
    Statistical analysis title
    		 Common Serotype 19F
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.27
    Statistical analysis title
    		 Common Serotype 23F
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.95
    Statistical analysis title
    		 Additional Serotype 1
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.18
         upper limit
    		 0.4
    Statistical analysis title
    		 Additional Serotype 3
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/PCV/13vPnC v PCV/23vPS/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.72
    Statistical analysis title
    		 Additional Serotype 5
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 0.51
    Statistical analysis title
    		 Additional Serotype 6A
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 1.14
    Statistical analysis title
    		 Additional Serotype 7F
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/PCV/13vPnC v PCV/23vPS/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1.28
    Statistical analysis title
    		 Additional Serotype 19A
    Statistical analysis description
    Ratio of GMCs (PCV/23vPS/13vPnC, PCV/PCV/13vPnC). 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 (PCV/23vPS/13vPnC, PCV/PCV/13vPnC).
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Ratio of GMCs
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.23

    Other pre-specified: Percentage of Subjects Reporting Prespecified Local Reactions Within 4 Days of Vaccination

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    End point title
    		 Percentage of Subjects Reporting Prespecified Local Reactions Within 4 Days of Vaccination
    End point description
    Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (greater than [>] 7.0 cm). Subjects may have been represented in more than 1 category. Safety population, included all subjects who received at least 1 dose of the study vaccine; n=number of subjects reporting the specific characteristic.
    End point type
    Other pre-specified
    End point timeframe
    Day 1 through Day 4
    End point values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Number of subjects analysed
    50 [11]
    39 [12]
    Units: percentage of subjects
    number (not applicable)
        Tenderness: Any (n=44, 30)
    88
    76.9
        Tenderness: Significant (n=6, 8)
    12
    20.5
        Redness: Any (n=25, 26)
    50
    66.7
        Redness: Mild (n=5, 6)
    10
    15.8
        Redness: Moderate (n=20, 20)
    40
    52.6
        Redness: Severe (n=5, 8)
    10
    21.1
        Swelling: Any (n=22, 23)
    44
    59
        Swelling: Mild (n=8, 10)
    16.3
    26.3
        Swelling: Moderate (n=14, 17)
    28.6
    44.7
        Swelling: Severe (n=1, 3)
    2
    7.9
    Notes
    [11] - N=number of subjects reporting yes for at least 1 day or no for all days.
    [12] - N=number of subjects reporting yes for at least 1 day or no for all days.
    Statistical analysis title
    		 Comparing Any Tenderness
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.253
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Significant Tenderness
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.38
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Any Redness
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.135
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Mild Redness
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.52
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Moderate Redness
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.283
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Severe Redness
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.225
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Any Swelling
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.202
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Mild Swelling
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.294
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Moderate Swelling
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.175
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Severe Swelling
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.314
    Method
    		 Fisher exact
    Confidence interval

    Other pre-specified: Percentage of Subjects Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination

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    End point title
    		 Percentage of Subjects Reporting Prespecified Systemic Reactions Within 4 Days of Vaccination
    End point description
    Pre-specified systemic events (any fever 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using a diary card. Subjects may have been represented in more than 1 category. Safety population; n=number of subjects reporting the specific characteristic
    End point type
    Other pre-specified
    End point timeframe
    Day 1 through Day 4
    End point values
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Number of subjects analysed
    50 [13]
    39 [14]
    Units: percentage of subjects
    number (not applicable)
        Fever ≥ 38 degrees C but ≤ 39 degrees C (n=1, 1)
    2
    2.8
        Decreased appetite (n=6, 4)
    12.2
    10.3
        Irritability (n=9, 4)
    18.4
    11.4
        Increased sleep (n=2, 5)
    4
    12.8
        Decreased sleep (n=0, 2)
    0
    5.1
        Rash (n=3, 1)
    6
    2.6
    Notes
    [13] - N=number of subjects reporting yes for at least 1 day or no for all days.
    [14] - N=number of subjects reporting yes for at least 1 day or no for all days.
    Statistical analysis title
    		 Comparing: Fever ≥ 38 Degrees C But ≤ 39 Degrees C
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Decreased Appetite
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.99
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Irritability
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.543
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Increased Sleep
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.233
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Decreased Sleep
    Comparison groups
    PCV/23vPS/13vPnC v PCV/PCV/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.198
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Rash
    Comparison groups
    PCV/PCV/13vPnC v PCV/23vPS/13vPnC
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.628
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through 1 Month after last study vaccination (28 Days). Local reactions and systemic events assessed within 4 days of dose (Day 1 through Day 4)
    Adverse event reporting additional description
    Same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject, as non-serious in another subject, or one subject may have experienced both the events. Version was not captured, here 0.0 is mentioned for dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    PCV/23vPS/13vPnC
    Reporting group description
    		 For this study, subjects received a single dose of 13vPnC. Subjects previously must have also received an infant series of 9V-MnCC also known as PCV followed by a toddler dose of 23vPS. Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other AEs N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9. Subjects affected and occurrences for Local Reactions (LRs) and Systemic Events (SEs) is same as data collected through e-diaries cannot be used to distinguish one occurrence from another within a subject/vaccination.

    Reporting group title
    PCV/PCV/13vPnC
    Reporting group description
    		 For this study, subjects received a single dose of 13vPnC. Subjects must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV). Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5. 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.

    Serious adverse events
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 39 (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
    		 PCV/23vPS/13vPnC PCV/PCV/13vPnC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 50 (88.00%)
    30 / 39 (76.92%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Fever ≥ 38°C but ≤ 39°C
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    1 / 49 (2.04%)
    1 / 36 (2.78%)
         occurrences all number
    1
    1
    Decreased appetite
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    6 / 49 (12.24%)
    4 / 39 (10.26%)
         occurrences all number
    6
    4
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    9 / 49 (18.37%)
    4 / 35 (11.43%)
         occurrences all number
    9
    4
    Increased sleep
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 50 (4.00%)
    5 / 39 (12.82%)
         occurrences all number
    2
    5
    Decreased sleep
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    0 / 48 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 39 (2.56%)
         occurrences all number
    3
    1
    Tenderness (Any)
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 50 (88.00%)
    30 / 39 (76.92%)
         occurrences all number
    44
    30
    Tenderness (Significant)
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 50 (12.00%)
    8 / 39 (20.51%)
         occurrences all number
    6
    8
    Redness (Any)
    alternative assessment type: Systematic
         subjects affected / exposed
    25 / 50 (50.00%)
    26 / 39 (66.67%)
         occurrences all number
    25
    26
    Redness (Mild)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    5 / 50 (10.00%)
    6 / 38 (15.79%)
         occurrences all number
    5
    6
    Redness (Moderate)
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    20 / 50 (40.00%)
    20 / 38 (52.63%)
         occurrences all number
    20
    20
    Redness (Severe)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    5 / 50 (10.00%)
    8 / 38 (21.05%)
         occurrences all number
    5
    8
    Swelling (Any)
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 50 (44.00%)
    23 / 39 (58.97%)
         occurrences all number
    22
    23
    Swelling (Mild)
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    8 / 49 (16.33%)
    10 / 38 (26.32%)
         occurrences all number
    8
    10
    Swelling (Moderate)
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    14 / 49 (28.57%)
    17 / 38 (44.74%)
         occurrences all number
    14
    17
    Swelling (Severe)
         subjects affected / exposed [10]
    1 / 49 (2.04%)
    3 / 38 (7.89%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 39 (2.56%)
         occurrences all number
    2
    1
    Diarrhoea
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 39 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    5
    Influenza
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    Gastroenteritis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Here number of subjects exposed signifies subjects reporting yes for at least 1 day or no for all days.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Apr 2009
    Minor clarification was made to temporary delay criterion, as recommended by the Icelandic Medicines Control Agency, to clarify timing of antibiotic therapy and treatment with oral steroid agents.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    In protocol, primary analysis was based on all available immunogenicity population and later modified to evaluable immunogenicity population in Statistical Analysis Plan based on subsequent similar studies and suitability for primary objective.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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