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    Clinical Trial Results:
    A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

    Summary
    EudraCT number
    2016-001117-25
    Trial protocol
    DK   ES   FI  
    Global end of trial date

    Results information
    Results version number
    v2(current)
    This version publication date
    16 Feb 2020
    First version publication date
    13 Jun 2019
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    V114-008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    04 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Oct 2018
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks ≥42 days to ≤90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific immunoglobulin G (IgG) ≥0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13™.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Mar 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 95
    Country: Number of subjects enrolled
    Denmark: 55
    Country: Number of subjects enrolled
    Finland: 95
    Country: Number of subjects enrolled
    Israel: 49
    Country: Number of subjects enrolled
    Spain: 68
    Country: Number of subjects enrolled
    United States: 689
    Worldwide total number of subjects
    1051
    EEA total number of subjects
    218
    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)
    1051
    Children (2-11 years)
    0
    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
    Healthy male and female infants approximately 2 months of age (between 42 and 90 days old) (inclusive) were enrolled in this study other inclusion/exclusion criteria applied.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    V114 Lot 1
    Arm description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
    Arm type
    Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Arm title
    V114 Lot 2
    Arm description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
    Arm type
    Experimental

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Arm title
    Prevnar 13™
    Arm description
    Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
    Arm type
    Active comparator

    Investigational medicinal product name
    Prevnar 13™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Number of subjects in period 1
    V114 Lot 1 V114 Lot 2 Prevnar 13™
    Started
    351
    350
    350
    Vaccination 1
    350
    347
    347
    Vaccination 2
    333
    335
    335
    Vaccination 3
    330
    331
    332
    Vaccination 4
    310
    306
    311
    Completed
    308
    305
    308
    Not completed
    43
    45
    42
         Protocol deviation
    2
    1
    5
         Physician decision
    1
    6
    -
         Lack of efficacy
    9
    12
    12
         Adverse event, serious fatal
    1
    -
    -
         Adverse event, non-fatal
    1
    1
    -
         Consent withdrawn by subject
    22
    17
    21
         Lost to follow-up
    7
    8
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114 Lot 1
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Reporting group title
    V114 Lot 2
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Reporting group title
    Prevnar 13™
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Reporting group values
    V114 Lot 1 V114 Lot 2 Prevnar 13™ Total
    Number of subjects
    351 350 350 1051
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    351 350 350 1051
    Gender Categorical
    Units: Subjects
        Female
    164 186 173 523
        Male
    187 164 177 528
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    49 36 53 138
        Not Hispanic Or Latino
    300 313 294 907
        Not Reported
    0 0 2 2
        Unkown
    2 1 1 4

    End points

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    End points reporting groups
    Reporting group title
    V114 Lot 1
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Reporting group title
    V114 Lot 2
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Reporting group title
    Prevnar 13™
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Subject analysis set title
    V114 Lot 1-Immunogenicity
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All participants who were not considered as protocol violators and had data available for the endpoint. Violations include but are not limited to: failure to receive the scheduled doses (at least 28 days between doses 1 and 2 and between doses 2 and 3, and dose 4 at 12 months to 15 months of age) of correct clinical material, and lack of valid serology results available from 28 to 42 days following the dose being analyzed.

    Subject analysis set title
    V114 Lot 2-Immunogenicity
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All participants who were not considered as protocol violators and had data available for the endpoint. Violations include but are not limited to: failure to receive the scheduled doses (at least 28 days between doses 1 and 2 and between doses 2 and 3, and dose 4 at 12 months to 15 months of age) of correct clinical material, and lack of valid serology results available from 28 to 42 days following the dose being analyzed.

    Subject analysis set title
    Prevnar 13™-Immunogenicity
    Subject analysis set type
    Per protocol
    Subject analysis set description
    All participants who were not considered as protocol violators and had data available for the endpoint. Violations include but are not limited to: failure to receive the scheduled doses (at least 28 days between doses 1 and 2 and between doses 2 and 3, and dose 4 at 12 months to 15 months of age) of correct clinical material, and lack of valid serology results available from 28 to 42 days following the dose being analyzed.

    Subject analysis set title
    V114 Lot 1-Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All participants that received at least 1 vaccination and had data available for endpoint.

    Subject analysis set title
    V114 Lot 2-Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All participants that received at least 1 vaccination and had data available for endpoint.

    Subject analysis set title
    Prevnar 13™-Safety
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All participants that received at least 1 vaccination and had data available for endpoint.

    Primary: Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3

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    End point title
    Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3
    End point description
    Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pnelectrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype.
    End point type
    Primary
    End point timeframe
    1 month post vaccination 3 (Month 5)
    End point values
    V114 Lot 1-Immunogenicity V114 Lot 2-Immunogenicity Prevnar 13™-Immunogenicity
    Number of subjects analysed
    278 [1]
    273 [2]
    291 [3]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Type 1 (n=278; 273; 291)
    96.8 (93.94 to 98.51)
    97.8 (95.28 to 99.19)
    96.9 (94.21 to 98.58)
        Type 3 (n=277; 273; 291)
    96.0 (93.01 to 98.00)
    94.1 (90.66 to 96.61)
    71.8 (66.28 to 76.92)
        Type 4 (n=273; 272; 288)
    98.2 (95.78 to 99.40)
    97.1 (94.29 to 98.72)
    95.1 (91.98 to 97.32)
        Type 5 (n=278; 272; 290)
    96.0 (93.03 to 98.01)
    96.0 (92.88 to 97.96)
    96.6 (93.75 to 98.33)
        Type 6A (n=278; 273; 290)
    90.6 (86.60 to 93.80)
    95.6 (92.45 to 97.71)
    96.2 (93.31 to 98.09)
        Type 6B (n=276; 273; 290)
    90.6 (86.50 to 93.75)
    92.3 (88.48 to 95.18)
    91.4 (87.54 to 94.34)
        Type 7F (n=278; 273; 290)
    99.6 (98.01 to 99.99)
    99.3 (97.38 to 99.91)
    99.0 (97.01 to 99.79)
        Type 9V (n=2778 273; 289)
    97.1 (94.41 to 98.75)
    97.8 (95.28 to 99.19)
    95.8 (92.86 to 97.84)
        Type 14 (n=277; 273; 289)
    99.3 (97.42 to 99.91)
    97.4 (94.79 to 98.96)
    97.2 (94.62 to 98.80)
        Type 18C (n=278; 273; 291)
    96.8 (93.94 to 98.51)
    98.2 (95.78 to 99.40)
    95.5 (92.48 to 97.60)
        Type 19A (n=278; 273; 290)
    98.9 (96.88 to 99.78)
    98.5 (96.29 to 99.60)
    98.6 (96.51 to 99.62)
        Type 19F (n=278; 273; 290)
    100.0 (98.68 to 100.00)
    98.9 (96.82 to 99.77)
    99.7 (98.09 to 99.99)
        Type 23F (n=278; 273; 290)
    92.4 (88.68 to 95.26)
    94.9 (91.55 to 97.17)
    90.7 (86.74 to 93.77)
    Notes
    [1] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [2] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [3] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    Statistical analysis title
    Type 1: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    3
    Notes
    [4] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 3: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    24.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    18.7
         upper limit
    30
    Notes
    [5] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 4: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [6]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    6.4
    Notes
    [6] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 5: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -0.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.9
         upper limit
    2.8
    Notes
    [7] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 6A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [8]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -5.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -10
         upper limit
    -1.6
    Notes
    [8] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 6B: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [9]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.7
         upper limit
    4
    Notes
    [9] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 7F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [10]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Differences in percentages
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    2.7
    Notes
    [10] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 9V: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [11]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.9
         upper limit
    4.6
    Notes
    [11] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 14: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [12]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    4.7
    Notes
    [12] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 18C: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [13]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.1
         upper limit
    4.7
    Notes
    [13] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 19A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [14]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.9
         upper limit
    2.6
    Notes
    [14] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 19F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [15]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1
         upper limit
    1.9
    Notes
    [15] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 23F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [16]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    6.5
    Notes
    [16] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 1: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [17]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2
         upper limit
    3.9
    Notes
    [17] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 3: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [18]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    22.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    16.5
         upper limit
    28.3
    Notes
    [18] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 4: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [19]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    1.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    5.4
    Notes
    [19] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 5: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [20]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.1
         upper limit
    2.7
    Notes
    [20] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 6A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [21]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -0.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.2
         upper limit
    2.8
    Notes
    [21] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 6B: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [22]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.7
         upper limit
    5.6
    Notes
    [22] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 7F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [23]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    2.4
    Notes
    [23] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 9V: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [24]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.1
         upper limit
    5.2
    Notes
    [24] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 14: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [25]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.8
         upper limit
    3.1
    Notes
    [25] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 18C: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [26]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    5.9
    Notes
    [26] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 19A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [27]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    2.2
    Notes
    [27] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 19F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [28]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    0.9
    Notes
    [28] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.
    Statistical analysis title
    Type 23F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13™
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [29]
    P-value
    < 0.001
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    4.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.1
         upper limit
    8.7
    Notes
    [29] - Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13™) being greater than -0.15 for each of the 13 shared serotypes.

    Primary: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3

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    End point title
    Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3
    End point description
    Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration of serotype-specific IgG will be assessed.
    End point type
    Primary
    End point timeframe
    1 month post Vaccination 3 (Month 5)
    End point values
    V114 Lot 1-Immunogenicity V114 Lot 2-Immunogenicity Prevnar 13™-Immunogenicity
    Number of subjects analysed
    278 [30]
    273 [31]
    291 [32]
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Type 1 (n=278; 273; 291)
    1.19 (1.10 to 1.27)
    1.37 (1.26 to 1.49)
    1.65 (1.50 to 1.82)
        Type 3 (n=277; 273; 291)
    1.04 (0.97 to 1.12)
    1.02 (0.93 to 1.11)
    0.53 (0.48 to 0.58)
        Type 4 (n=273; 272; 288)
    1.30 (1.21 to 1.40)
    1.27 (1.17 to 1.37)
    1.26 (1.14 to 1.38)
        Type 5 (n=278; 272; 290)
    1.37 (1.25 to 1.50)
    1.45 (1.32 to 1.59)
    1.75 (1.58 to 1.94)
        Type 6A (n=278; 273; 290)
    1.42 (1.27 to 1.59)
    1.48 (1.34 to 1.63)
    2.62 (2.35 to 2.92)
        Type 6B (n=276; 273; 290)
    1.95 (1.68 to 2.28)
    1.71 (1.49 to 1.96)
    1.89 (1.64 to 2.18)
        Type 7F (n=278; 273; 290)
    2.43 (2.26 to 2.62)
    2.42 (2.23 to 2.62)
    2.98 (2.72 to 3.26)
        Type 9V (n=278; 273; 289)
    1.40 (1.28 to 1.52)
    1.70 (1.56 to 1.86)
    1.59 (1.44 to 1.76)
        Type 14 (n=277; 273; 289)
    5.08 (4.63 to 5.58)
    4.78 (4.27 to 5.34)
    5.79 (5.11 to 6.55)
        Type 18C (n=278; 273; 291)
    1.24 (1.15 to 1.35)
    1.65 (1.52 to 1.79)
    1.67 (1.52 to 1.82)
        Type 19A (n=278; 273; 290)
    1.63 (1.52 to 1.76)
    1.64 (1.51 to 1.78)
    1.99 (1.83 to 2.18)
        Type 19F (n=278; 273; 290)
    2.26 (2.10 to 2.43)
    2.33 (2.15 to 2.53)
    2.57 (2.38 to 2.78)
        Type 23F (n=278; 273; 290)
    1.22 (1.10 to 1.35)
    1.47 (1.32 to 1.63)
    1.25 (1.11 to 1.40)
        Type 22F (n=278; 273; 291)
    4.80 (4.40 to 5.24)
    4.18 (3.76 to 4.63)
    0.05 (0.05 to 0.06)
        Type 33F (n=278; 273; 289)
    1.58 (1.34 to 1.86)
    1.51 (1.30 to 1.75)
    0.05 (0.04 to 0.05)
    Notes
    [30] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [31] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [32] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    Statistical analysis title
    GMC Ratio-Type 1: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on analysis of variance (ANOVA) model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.64
         upper limit
    0.81
    Statistical analysis title
    GMC Ratio-Type 3: Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.75
         upper limit
    2.23
    Statistical analysis title
    GMC Ratio-Type 4: Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.92
         upper limit
    1.16
    Statistical analysis title
    GMC Ratio-Type 5: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    0.89
    Statistical analysis title
    GMC Ratio-Type 6A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.54
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.47
         upper limit
    0.63
    Statistical analysis title
    GMC Ratio Type 6B: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.03
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.84
         upper limit
    1.26
    Statistical analysis title
    GMC Ratio-Type 7F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    0.92
    Statistical analysis title
    GMC Ratio-Type 9V: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    1
    Statistical analysis title
    GMC Ratio-Type 14: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.75
         upper limit
    1.03
    Statistical analysis title
    GMC Ratio-Type 18C: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.66
         upper limit
    0.84
    Statistical analysis title
    GMC Ratio-Type 23F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.84
         upper limit
    1.13
    Statistical analysis title
    GMC Ratio-Type 22F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    92.05
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    80.84
         upper limit
    104.81
    Statistical analysis title
    GMC Ratio-Type 33F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    34.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    28.5
         upper limit
    41.54
    Statistical analysis title
    GMC Ratio-Type 1: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    0.94
    Statistical analysis title
    GMC Ratio-Type 3: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.71
         upper limit
    2.18
    Statistical analysis title
    GMC Ratio-Type 4: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    1.14
    Statistical analysis title
    GMC Ratio-Type 5: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    0.94
    Statistical analysis title
    GMC Ratio-Type 6A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.49
         upper limit
    0.66
    Statistical analysis title
    GMC Ratio-Type 6B: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    1.1
    Statistical analysis title
    GMC Ratio-Type 7F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    0.91
    Statistical analysis title
    GMC Ratio-Type 9V: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.94
         upper limit
    1.22
    Statistical analysis title
    GMC Ratio-Type 14: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    0.97
    Statistical analysis title
    GMC Ratio-Type 18C: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    1.12
    Statistical analysis title
    GMC Ratio-Type 23F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.01
         upper limit
    1.37
    Statistical analysis title
    GMC Ratio-Type 19F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.91
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.01
    Statistical analysis title
    GMC Ratio-Type 22F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    80.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    70.3
         upper limit
    91.24
    Statistical analysis title
    GMC Ratio-Type 33F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    32.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    27.25
         upper limit
    39.78
    Statistical analysis title
    GMC Ratio-Type 19F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    0.98
    Statistical analysis title
    GMC Ratio-Type 19A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    0.92
    Statistical analysis title
    GMC Ratio-Type 19A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    564
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    0.92

    Primary: Percentage of Participants Who Experience at Least 1 Adverse Event

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    End point title
    Percentage of Participants Who Experience at Least 1 Adverse Event
    End point description
    An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor’s product, is also an AE. The percentage of participants with one or more AEs was assessed.
    End point type
    Primary
    End point timeframe
    Up to 1 month post Vaccination 4 (up to 14 months)
    End point values
    V114 Lot 1-Safety V114 Lot 2-Safety Prevnar 13™-Safety
    Number of subjects analysed
    350
    347
    347
    Units: Percentage of Participants
        number (not applicable)
    95.7
    97.7
    95.7
    Statistical analysis title
    V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 1-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    697
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.1
         upper limit
    3.2
    Statistical analysis title
    V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 2-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    694
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in Percentages
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.7
         upper limit
    5

    Primary: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event

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    End point title
    Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
    End point description
    The percentage of participants who discontinued the study because of an AE (as defined above) was assessed.
    End point type
    Primary
    End point timeframe
    Up to 1 month post Vaccination 4 (up to 14 months)
    End point values
    V114 Lot 1-Safety V114 Lot 2-Safety Prevnar 13™-Safety
    Number of subjects analysed
    350
    347
    347
    Units: Percentage of participants
        number (not applicable)
    0.3
    0.3
    0.0
    Statistical analysis title
    V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 2-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    694
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in Percentages
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    1.6
    Statistical analysis title
    V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 1-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    697
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    Difference in Perentages
    Point estimate
    0.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.8
         upper limit
    1.6

    Primary: Percentage of Participants with a Solicited Injection-site Adverse Event

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    End point title
    Percentage of Participants with a Solicited Injection-site Adverse Event
    End point description
    Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed
    End point type
    Primary
    End point timeframe
    Up to 14 days post any vaccination
    End point values
    V114 Lot 1-Safety V114 Lot 2-Safety Prevnar 13™-Safety
    Number of subjects analysed
    350
    347
    347
    Units: Percentage of participants
        number (not applicable)
    76.6
    76.7
    70.3
    Statistical analysis title
    V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 1-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    697
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.062
    Method
    Miettinen & Nurminen
    Parameter type
    Difference in percentages
    Point estimate
    6.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3
         upper limit
    12.8
    Statistical analysis title
    V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 2-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    694
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.059
    Method
    Miettinen & Nurminen
    Parameter type
    Difference in percentages
    Point estimate
    6.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.2
         upper limit
    12.9

    Primary: Percentage of Participants with a Solicited Systemic Adverse Event

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    End point title
    Percentage of Participants with a Solicited Systemic Adverse Event
    End point description
    Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed.
    End point type
    Primary
    End point timeframe
    Up to 14 days post any vaccination
    End point values
    V114 Lot 1-Safety V114 Lot 2-Safety Prevnar 13™-Safety
    Number of subjects analysed
    350
    347
    347
    Units: Percentage of Participants
        number (not applicable)
    90.3
    92.2
    89.6
    Statistical analysis title
    V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 1 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 1-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    697
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.772
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.9
         upper limit
    5.2
    Statistical analysis title
    V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    Difference in percentages calculated as V114 Lot 2 minus Prevnar 13™. Confidence intervals based on Miettinen and Nurminen method.
    Comparison groups
    V114 Lot 2-Safety v Prevnar 13™-Safety
    Number of subjects included in analysis
    694
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.235
    Method
    Miettinen and Nurminen
    Parameter type
    Difference in Percentages
    Point estimate
    2.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    7

    Secondary: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4

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    End point title
    Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4
    End point description
    Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
    End point type
    Secondary
    End point timeframe
    1 month post vaccination 4 (Month 11-14)
    End point values
    V114 Lot 1-Immunogenicity V114 Lot 2-Immunogenicity Prevnar 13™-Immunogenicity
    Number of subjects analysed
    273 [33]
    265 [34]
    277 [35]
    Units: µg/mL
    arithmetic mean (confidence interval 95%)
        Type 1 (n=273; 265; 277)
    1.75 (1.60 to 1.92)
    2.00 (1.84 to 2.19)
    2.47 (2.24 to 2.72)
        Type 3 (n=273; 265; 277)
    1.12 (1.03 to 1.22)
    1.16 (1.06 to 1.26)
    0.78 (0.71 to 0.85)
        Type 4 (n=273; 265; 277)
    1.66 (1.49 to 1.85)
    1.53 (1.37 to 1.70)
    1.88 (1.69 to 2.10)
        Type 5 (n=273: 265; 277)
    3.43 (3.09 to 3.80)
    3.24 (2.94 to 3.57)
    4.72 (4.27 to 5.21)
        Type 6A (n=273; 265; 277)
    4.97 (4.49 to 5.51)
    4.60 (4.21 to 5.04)
    6.94 (6.27 to 7.69)
        Type 6B (n=273; 265; 276)
    7.38 (6.68 to 8.15)
    5.74 (5.24 to 6.28)
    6.91 (6.25 to 7.63)
        Type 7F (n=273; 265; 277)
    4.25 (3.87 to 4.66)
    4.47 (4.07 to 4.91)
    6.29 (5.73 to 6.91)
        Type 9V (n=273; 265; 276)
    2.43 (2.20 to 2.69)
    2.71 (2.47 to 2.96)
    3.53 (3.20 to 3.89)
        Type 14 (n=273; 265; 277)
    7.29 (6.54 to 8.14)
    7.01 (6.30 to 7.80)
    8.28 (7.47 to 9.19)
        Type 18C (n=273; 265; 277)
    2.75 (2.47 to 3.05)
    3.15 (2.88 to 3.45)
    2.94 (2.65 to 3.26)
        Type 19A (n=273; 265; 277)
    5.80 (5.33 to 6.31)
    5.35 (4.89 to 5.87)
    6.53 (5.93 to 7.18)
        Type 19F (n=273; 265; 277)
    5.29 (4.81 to 5.82)
    4.94 (4.53 to 5.39)
    5.47 (4.97 to 6.01)
        Type 23F (n=273; 265; 277)
    2.52 (2.25 to 2.83)
    3.12 (2.82 to 3.44)
    3.38 (3.02 to 3.78)
        Type 22F (n=273; 265; 277)
    8.60 (7.85 to 9.42)
    7.54 (6.91 to 8.23)
    0.06 (0.05 to 0.06)
        Type 33F (n=273; 265; 272)
    5.02 (4.59 to 5.49)
    4.39 (4.06 to 4.73)
    0.06 (0.05 to 0.06)
    Notes
    [33] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [34] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [35] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    Statistical analysis title
    GMC Ratio-Type 1: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    Prevnar 13™-Immunogenicity v V114 Lot 1-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.62
         upper limit
    0.81
    Statistical analysis title
    GMC Ratio-Type 3: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.27
         upper limit
    1.63
    Statistical analysis title
    GMC Ratio-Type 4: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.02
    Statistical analysis title
    GMC Ratio-Type 5: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.63
         upper limit
    0.84
    Statistical analysis title
    GMC Ratio-Type 6A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.62
         upper limit
    0.82
    Statistical analysis title
    GMC Ratio-Type 6B: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.93
         upper limit
    1.22
    Statistical analysis title
    GMC Ratio-Type 7F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.67
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.59
         upper limit
    0.77
    Statistical analysis title
    GMC Ratio-Type 9V: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    0.79
    Statistical analysis title
    GMC Ratio-Type 14: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.02
    Statistical analysis title
    GMC Ratio-Type 18C: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    1.08
    Statistical analysis title
    GMC Ratio-Type 19F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    1.1
    Statistical analysis title
    GMC Ratio-Type 19A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.78
         upper limit
    1.01
    Statistical analysis title
    GMC Ratio-Type 23F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.75
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.64
         upper limit
    0.87
    Statistical analysis title
    GMC Ratio-Type 22F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    149.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    130.23
         upper limit
    172.06
    Statistical analysis title
    GMC Ratio-Type 33F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    550
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    90.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    79.93
         upper limit
    102.12
    Statistical analysis title
    GMC Ratio-Type 1: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    0.93
    Statistical analysis title
    GMC Ratio-Type 3: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.31
         upper limit
    1.68
    Statistical analysis title
    GMC Ratio-Type 4: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.81
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    0.94
    Statistical analysis title
    GMC Ratio-Type 5: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    0.79
    Statistical analysis title
    GMC Ratio-Type 6A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.66
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.58
         upper limit
    0.76
    Statistical analysis title
    GMC Ratio-Type 6B: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    0.95
    Statistical analysis title
    GMC Ratio-Type 9V: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.67
         upper limit
    0.88
    Statistical analysis title
    GMC Ratio-Type 7F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.71
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.62
         upper limit
    0.81
    Statistical analysis title
    GMC Ratio-Type 18C: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.93
         upper limit
    1.24
    Statistical analysis title
    GMC Ratio-Type 14: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.85
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    0.98
    Statistical analysis title
    GMC Ratio-Type 19A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    0.93
    Statistical analysis title
    GMC Ratio-Type 19F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    1.03
    Statistical analysis title
    GMC Ratio-Type 22F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    131.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    114.05
         upper limit
    151
    Statistical analysis title
    GMC Ratio-Type 23F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    1.08
    Statistical analysis title
    GMC Ratio-Type 33F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    542
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    78.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    69.82
         upper limit
    89.36

    Secondary: Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4

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    End point title
    Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4
    End point description
    Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay.
    End point type
    Secondary
    End point timeframe
    Before Vaccination 4 (Month 10 to 13)
    End point values
    V114 Lot 1-Immunogenicity V114 Lot 2-Immunogenicity Prevnar 13™-Immunogenicity
    Number of subjects analysed
    280 [36]
    283 [37]
    287 [38]
    Units: µg/mL
    arithmetic mean (confidence interval 95%)
        Type 1 (n=280; 283; 287)
    0.32 (0.29 to 0.34)
    0.35 (0.33 to 0.38)
    0.46 (0.43 to 0.50)
        Type 3 (n=280; 283; 287)
    0.25 (0.23 to 0.27)
    0.26 (0.24 to 0.29)
    0.12 (0.11 to 0.14)
        Type 4 (n=280; 283; 287)
    0.26 (0.24 to 0.28)
    0.26 (0.24 to 0.27)
    0.27 (0.25 to 0.29)
        Type 5 (n=280; 283; 287)
    0.74 (0.69 to 0.80)
    0.74 (0.68 to 0.79)
    0.86 (0.80 to 0.92)
        Type 6A (n=280; 283; 287)
    0.33 (0.30 to 0.37)
    0.38 (0.35 to 0.41)
    0.58 (0.54 to 0.64)
        Type 6B (n=280; 283; 287)
    0.61 (0.55 to 0.67)
    0.56 (0.51 to 0.62)
    0.50 (0.46 to 0.55)
        Type 7F (n=280; 283; 287)
    0.77 (0.72 to 0.83)
    0.81 (0.76 to 0.88)
    1.05 (0.98 to 1.12)
        Type 9V (n=280; 283; 287)
    0.40 (0.37 to 0.44)
    0.41 (0.38 to 0.44)
    0.48 (0.44 to 0.52)
        Type 14 (n=280; 283; 287)
    1.34 (1.22 to 1.48)
    1.24 (1.12 to 1.37)
    2.03 (1.83 to 2.24)
        Type 18C (n=280; 283; 287)
    0.28 (0.25 to 0.30)
    0.41 (0.38 to 0.44)
    0.34 (0.32 to 0.37)
        Type 19A (n=280; 283; 287)
    0.40 (0.36 to 0.44)
    0.41 (0.37 to 0.45)
    0.50 (0.45 to 0.55)
        Type 19F (n=280; 283; 287)
    0.43 (0.39 to 0.46)
    0.47 (0.43 to 0.52)
    0.57 (0.52 to 0.63)
        Type 23F (n=280; 283; 287)
    0.29 (0.26 to 0.32)
    0.37 (0.33 to 0.40)
    0.32 (0.28 to 0.36)
        Type 22F (n=280; 283; 287)
    1.30 (1.20 to 1.40)
    1.23 (1.14 to 1.32)
    0.05 (0.04 to 0.05)
        Type 33F (n=280; 283; 286)
    1.01 (0.92 to 1.11)
    0.95 (0.87 to 1.04)
    0.04 (0.04 to 0.04)
    Notes
    [36] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [37] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    [38] - Includes Per-protocol participants with data for endpoint; n's vary with serotype
    Statistical analysis title
    GMC Ratio-Type 1: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.69
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.62
         upper limit
    0.76
    Statistical analysis title
    GMC Ratio-Type 3: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.75
         upper limit
    2.28
    Statistical analysis title
    GMC Ratio-Type 4: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.86
         upper limit
    1.07
    Statistical analysis title
    GMC Ratio-Type 5: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.78
         upper limit
    0.96
    Statistical analysis title
    GMC Ratio-Type 6A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    0.65
    Statistical analysis title
    GMC Ratio-Type 6B: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.06
         upper limit
    1.39
    Statistical analysis title
    GMC Ratio-Type 7F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.67
         upper limit
    0.82
    Statistical analysis title
    GMC Ratio-Type 9V: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.74
         upper limit
    0.95
    Statistical analysis title
    GMC Ratio-Type 14: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.66
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.58
         upper limit
    0.76
    Statistical analysis title
    GMC Ratio-Type 18C: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.72
         upper limit
    0.9
    Statistical analysis title
    GMC Ratio-Type 19A: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.79
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.69
         upper limit
    0.91
    Statistical analysis title
    GMC Ratio-Type 19F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.74
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.65
         upper limit
    0.85
    Statistical analysis title
    GMC Ratio-Type 23F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    1.07
    Statistical analysis title
    GMC Ratio-Type 22F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    27.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    24.64
         upper limit
    31.4
    Statistical analysis title
    GMC Ratio-Type 33F: V114 Lot 1 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 1/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 1-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    25.57
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    22.61
         upper limit
    28.92
    Statistical analysis title
    GMC Ratio-Type 1: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC ratio
    Point estimate
    0.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.69
         upper limit
    0.85
    Statistical analysis title
    GMC Ratio-Type 3: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.84
         upper limit
    2.39
    Statistical analysis title
    GMC Ratio-Type 4: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.94
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    1.05
    Statistical analysis title
    GMC Ratio-Type 5: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    0.95
    Statistical analysis title
    GMC Ratio-Type 6A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.65
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.57
         upper limit
    0.74
    Statistical analysis title
    GMC Ratio-Type 6B: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.12
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.97
         upper limit
    1.28
    Statistical analysis title
    GMC Ratio-Type 7F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    0.86
    Statistical analysis title
    GMC Ratio-Type 9V: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.86
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    0.97
    Statistical analysis title
    GMC Ratio-Type 18C: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.07
         upper limit
    1.34
    Statistical analysis title
    GMC Ratio-Type 14: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.53
         upper limit
    0.7
    Statistical analysis title
    GMC Ratio-Type 19A: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    0.94
    Statistical analysis title
    GMC Ratio-Type 19F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    0.83
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    0.94
    Statistical analysis title
    GMC Ratio-Type 22F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    26.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    23.31
         upper limit
    29.68
    Statistical analysis title
    GMC Ratio-Type 23F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    1.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.99
         upper limit
    1.35
    Statistical analysis title
    GMC Ratio-Type 33F: V114 Lot 2 versus Prevnar 13™
    Statistical analysis description
    IgG GMC Ratio (V114 Lot 2/Prevnar 13™) based on ANOVA model with log-transformed IgG antibody responses as response variable and vaccination group as covariate.
    Comparison groups
    V114 Lot 2-Immunogenicity v Prevnar 13™-Immunogenicity
    Number of subjects included in analysis
    570
    Analysis specification
    Pre-specified
    Analysis type
    other
    Method
    Parameter type
    GMC Ratio
    Point estimate
    24.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    21.32
         upper limit
    27.25

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months)
    Adverse event reporting additional description
    All enrolled participants that received at least 1 vaccination
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    V114 Lot 1
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Reporting group title
    V114 Lot 2
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Reporting group title
    Prevnar 13™
    Reporting group description
    Infants received a 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)

    Serious adverse events
    V114 Lot 1 V114 Lot 2 Prevnar 13™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    18 / 350 (5.14%)
    19 / 347 (5.48%)
    15 / 347 (4.32%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apparent life threatening event
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obliterative bronchiolitis
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Serum sickness
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fontanelle bulging
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infantile colic
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukoplakia oral
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pylorospasm
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular atrophy
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Purpura
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 350 (0.29%)
    2 / 347 (0.58%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    2 / 350 (0.57%)
    2 / 347 (0.58%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 350 (0.57%)
    1 / 347 (0.29%)
    2 / 347 (0.58%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemophilus bacteraemia
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    3 / 347 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 350 (0.29%)
    0 / 347 (0.00%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    0 / 347 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 350 (0.00%)
    0 / 347 (0.00%)
    1 / 347 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 350 (0.00%)
    1 / 347 (0.29%)
    2 / 347 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    V114 Lot 1 V114 Lot 2 Prevnar 13™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    333 / 350 (95.14%)
    337 / 347 (97.12%)
    330 / 347 (95.10%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    26 / 350 (7.43%)
    19 / 347 (5.48%)
    19 / 347 (5.48%)
         occurrences all number
    31
    23
    19
    Nasal congestion
         subjects affected / exposed
    21 / 350 (6.00%)
    15 / 347 (4.32%)
    9 / 347 (2.59%)
         occurrences all number
    28
    15
    10
    Rhinorrhoea
         subjects affected / exposed
    15 / 350 (4.29%)
    21 / 347 (6.05%)
    16 / 347 (4.61%)
         occurrences all number
    16
    29
    16
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    221 / 350 (63.14%)
    241 / 347 (69.45%)
    233 / 347 (67.15%)
         occurrences all number
    564
    661
    573
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    151 / 350 (43.14%)
    164 / 347 (47.26%)
    153 / 347 (44.09%)
         occurrences all number
    256
    280
    259
    Injection site pain
         subjects affected / exposed
    198 / 350 (56.57%)
    200 / 347 (57.64%)
    162 / 347 (46.69%)
         occurrences all number
    385
    393
    327
    Injection site induration
         subjects affected / exposed
    117 / 350 (33.43%)
    109 / 347 (31.41%)
    113 / 347 (32.56%)
         occurrences all number
    206
    195
    200
    Pyrexia
         subjects affected / exposed
    115 / 350 (32.86%)
    128 / 347 (36.89%)
    141 / 347 (40.63%)
         occurrences all number
    199
    221
    252
    Injection site swelling
         subjects affected / exposed
    98 / 350 (28.00%)
    100 / 347 (28.82%)
    91 / 347 (26.22%)
         occurrences all number
    157
    176
    142
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    295 / 350 (84.29%)
    301 / 347 (86.74%)
    294 / 347 (84.73%)
         occurrences all number
    1118
    1255
    1113
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    39 / 350 (11.14%)
    44 / 347 (12.68%)
    52 / 347 (14.99%)
         occurrences all number
    54
    61
    59
    Teething
         subjects affected / exposed
    17 / 350 (4.86%)
    26 / 347 (7.49%)
    19 / 347 (5.48%)
         occurrences all number
    23
    38
    22
    Vomiting
         subjects affected / exposed
    27 / 350 (7.71%)
    23 / 347 (6.63%)
    34 / 347 (9.80%)
         occurrences all number
    31
    24
    45
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    158 / 350 (45.14%)
    175 / 347 (50.43%)
    154 / 347 (44.38%)
         occurrences all number
    303
    332
    289
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    25 / 350 (7.14%)
    20 / 347 (5.76%)
    19 / 347 (5.48%)
         occurrences all number
    27
    23
    22
    Otitis media
         subjects affected / exposed
    16 / 350 (4.57%)
    16 / 347 (4.61%)
    18 / 347 (5.19%)
         occurrences all number
    16
    16
    18
    Upper respiratory tract infection
         subjects affected / exposed
    26 / 350 (7.43%)
    24 / 347 (6.92%)
    34 / 347 (9.80%)
         occurrences all number
    27
    29
    42

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 May 2018
    Amendment 1: Primary reason for the amendment was to remove the exploratory biomarker section. Other changes included removing 2 non-pertinent immunogenicity outcomes.

    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.
    None reported
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