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    Clinical Trial Results:
    A Phase 3 Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults 18 to 49 Years of Age

    Summary
    EudraCT number
    		 2022-000265-41
    Trial protocol
    		 FI   ES   AT   DK   PL  
    Global end of trial date
    25 May 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2024
    First version publication date
    22 May 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V116-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05464420
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, 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
    Final
    Date of interim/final analysis
    25 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in pneumococcal vaccine-naïve adults 18 to 49 years of age. The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
    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
    12 Aug 2022
    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
    Austria: 113
    Country: Number of subjects enrolled
    Canada: 111
    Country: Number of subjects enrolled
    Denmark: 120
    Country: Number of subjects enrolled
    Finland: 138
    Country: Number of subjects enrolled
    Israel: 280
    Country: Number of subjects enrolled
    Poland: 122
    Country: Number of subjects enrolled
    Spain: 228
    Country: Number of subjects enrolled
    United States: 1050
    Worldwide total number of subjects
    2162
    EEA total number of subjects
    721
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2162
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 2162 participants were randomized and 2157 were vaccinated and included in the safety analysis population. One participant initially randomized to the V116 Lot 2 arm received V116 Lot 1, one participant initially randomized to the V116 Lot 1 arm received V116 Lot 3, and one participant initially randomized to the V116 Lot 2 arm received PPSV23.

    Pre-assignment
    Screening details
    		 Healthy pneumococcal vaccine-naïve adults between 18 and 49 years of age were enrolled in this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V116 Lot 1
    Arm description
    		 Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

    Arm title
    		 V116 Lot 2
    Arm description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

    Arm title
    		 V116 Lot 3
    Arm description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

    Arm title
    		 PPSV23
    Arm description
    		 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PPSV23
    Investigational medicinal product code
    Other name
    PNEUMOVAX™23
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

    Number of subjects in period 1
    		V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Started
    541
    540
    541
    540
    Vaccinated
    539
    538
    540
    540
    Completed
    521
    520
    525
    526
    Not completed
    20
    20
    16
    14
         Consent withdrawn by subject
    4
    8
    3
    1
         Unable to adhere to study schedule
    -
    -
    1
    -
         Randomized in Error Without Study Treatment
    -
    1
    -
    -
         Death
    -
    -
    -
    1
         Lost to follow-up
    16
    11
    11
    11
         Protocol deviation
    -
    -
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V116 Lot 1
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.

    Reporting group title
    V116 Lot 2
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.

    Reporting group title
    V116 Lot 3
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.

    Reporting group title
    PPSV23
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.

    Reporting group values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23 Total
    Number of subjects
    		 541 540 541 540 2162
    Age categorical
    Units: Participants
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 541 540 541 540 2162
        From 65-84 years
    		 0 0 0 0 0
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 34.8 ( 9.3 ) 34.8 ( 9.2 ) 34.3 ( 9.3 ) 34.4 ( 9.2 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 305 321 311 310 1247
        Male
    		 236 219 230 230 915
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 6 2 4 4 16
        Asian
    		 9 12 6 8 35
        Native Hawaiian or Other Pacific Islander
    		 2 1 0 1 4
        Black or African American
    		 49 43 55 48 195
        White
    		 458 458 458 453 1827
        More than one race
    		 16 24 16 26 82
        Unknown or Not Reported
    		 1 0 2 0 3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 98 104 113 107 422
        Not Hispanic or Latino
    		 440 434 420 430 1724
        Unknown or Not Reported
    		 3 2 8 3 16

    End points

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    End points reporting groups
    Reporting group title
    V116 Lot 1
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.

    Reporting group title
    V116 Lot 2
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.

    Reporting group title
    V116 Lot 3
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.

    Reporting group title
    PPSV23
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.

    Subject analysis set title
    V116 Lot 1
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.

    Subject analysis set title
    V116 Lot 2
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.

    Subject analysis set title
    V116 Lot 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.

    Subject analysis set title
    V116 Combined Lots 1, 2, and 3
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single 0.5 mL IM dose of either V116 Lot 1, 2, or 3 on Day 1.

    Subject analysis set title
    PPSV23
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.

    Subject analysis set title
    V116 Combined Lots 1, 2, and 3
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a single 0.5 mL IM dose of either V116 Lot 1, 2, or 3 on Day 1.

    Subject analysis set title
    PPSV23
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.

    Primary: Percentage of participants with solicited injection-site adverse events (AEs) following vaccination with separate V116 lots

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    End point title
    		 Percentage of participants with solicited injection-site adverse events (AEs) following vaccination with separate V116 lots [1]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who received one of three lots of V116 were analyzed according to the vaccination they received. One participant randomized to the V116 Lot 1 arm received V116 Lot 3, one participant randomized to the V116 Lot 2 arm received V116 Lot 1, and one participant randomized to the V116 Lot 2 arm received PPSV23.
    End point type
    Primary
    End point timeframe
    Up to 5 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    536
    541
    0 [2]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site erythema
    13.4 (10.6 to 16.5)
    14.2 (11.3 to 17.4)
    13.1 (10.4 to 16.3)
    ( to )
        Injection site pain
    72.9 (68.9 to 76.6)
    72.9 (69.0 to 76.7)
    73.9 (70.0 to 77.6)
    ( to )
        Injection site swelling
    12.4 (9.8 to 15.5)
    15.3 (12.4 to 18.6)
    11.8 (9.2 to 14.9)
    ( to )
    Notes
    [2] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Primary: Percentage of participants with solicited injection-site AEs following vaccination: combined lots of V116 or PPSV23

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    End point title
    		 Percentage of participants with solicited injection-site AEs following vaccination: combined lots of V116 or PPSV23
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs included pain/tenderness, redness/erythema, and swelling. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated. All randomized participants who received study vaccination were analyzed according to the vaccination they received. One participant randomized into the V116 Lot 2 group incorrectly received PPSV23.
    End point type
    Primary
    End point timeframe
    Up to 5 days
    End point values
    		 V116 Combined Lots 1, 2, and 3 PPSV23
    Number of subjects analysed
    1616
    541
    Units: Percentage of Participants
    number (not applicable)
        Injection site erythema
    13.6
    7.6
        Injection site pain
    73.3
    60.6
        Injection site swelling
    13.2
    7.6
    Statistical analysis title
    		 Injection site erythema: V116 Combined Lots-PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% confidence intervals (CI) were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 8.6
    Statistical analysis title
    		 Injection site swelling:V116 Combined Lots-PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% CI were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.6
         upper limit
    		 8.2
    Statistical analysis title
    		 Injection site pain: V116 Combined Lots - PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% CI were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    12.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8
         upper limit
    		 17.3

    Primary: Percentage of participants with solicited systemic AEs following vaccination with separate V116 lots

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    End point title
    		 Percentage of participants with solicited systemic AEs following vaccination with separate V116 lots [3]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who received one of three lots of V116 were analyzed according to the vaccination they received. One participant randomized to the V116 Lot 1 arm received V116 Lot 3, one participant randomized to the V116 Lot 2 arm received V116 Lot 1, and one participant randomized to the V116 Lot 2 arm received PPSV23.
    End point type
    Primary
    End point timeframe
    Up to 5 days
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    536
    541
    0 [4]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Fatigue
    38.0 (33.9 to 42.3)
    34.0 (30.0 to 38.1)
    34.4 (30.4 to 38.6)
    ( to )
        Headache
    28.0 (24.3 to 32.0)
    26.1 (22.4 to 30.1)
    27.5 (23.8 to 31.5)
    ( to )
        Myalgia
    18.2 (15.0 to 21.7)
    13.6 (10.8 to 16.8)
    17.2 (14.1 to 20.6)
    ( to )
        Pyrexia
    3.2 (1.8 to 5.0)
    2.2 (1.2 to 3.9)
    3.5 (2.1 to 5.4)
    ( to )
    Notes
    [4] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Primary: Percentage of participants with solicited systemic AEs following vaccination: combined lots of V116 or PPSV23

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    End point title
    		 Percentage of participants with solicited systemic AEs following vaccination: combined lots of V116 or PPSV23
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs included headache, muscle aches/myalgia, tiredness/fatigue, and pyrexia. Per the statistical analysis plan, no within group method of dispersion (MOD) were planned or calculated. All randomized participants who received study vaccination were analyzed according to the vaccination they received. One participant randomized into the V116 Lot 2 group incorrectly received PPSV23.
    End point type
    Primary
    End point timeframe
    Up to 5 days
    End point values
    		 V116 Combined Lots 1, 2, and 3 PPSV23
    Number of subjects analysed
    1616
    541
    Units: Percentage of Participants
    number (not applicable)
        Fatigue
    35.5
    34.0
        Headache
    27.2
    21.4
        Myalgia
    16.3
    8.7
        Pyrexia
    3.0
    2.2
    Statistical analysis title
    		 Fatigue: V116 Combined Lots - PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% CI were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 6
    Statistical analysis title
    		 Pyrexia: V116 Combined Lots - PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% CI were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 2.1
    Statistical analysis title
    		 Myalgia: V116 Combined Lots - PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% CI were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    7.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.5
         upper limit
    		 10.5
    Statistical analysis title
    		 Headache: V116 Combined Lots - PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% CI were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    5.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 9.7

    Primary: Percentage of participants with vaccine-related serious adverse events (SAEs) following vaccination with separate V116 lots

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    End point title
    		 Percentage of participants with vaccine-related serious adverse events (SAEs) following vaccination with separate V116 lots [5]
    End point description
    An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who received one of three lots of V116 were analyzed according to the vaccination they received. One participant randomized to the V116 Lot 1 arm received V116 Lot 3, one participant randomized to the V116 Lot 2 arm received V116 Lot 1, and one participant randomized to the V116 Lot 2 arm received PPSV23.
    End point type
    Primary
    End point timeframe
    Up to 194 days
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics are presented.
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    536
    541
    0 [6]
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 0.7)
    0.0 (0.0 to 0.7)
    0.0 (0.0 to 0.7)
    ( to )
    Notes
    [6] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Primary: Percentage of participants with vaccine-related SAEs following vaccination: combined lots of V116 or PPSV23

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    End point title
    		 Percentage of participants with vaccine-related SAEs following vaccination: combined lots of V116 or PPSV23
    End point description
    An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life threatening, required inpatient hospitalization or prolonged existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. SAEs that were reported to be at least possibly related by the investigator to study vaccination were reported. Per the statistical analysis plan, no within group MOD were planned or calculated. All randomized participants who received study vaccination were analyzed according to the vaccination they received. One participant randomized into the V116 Lot 2 group incorrectly received PPSV23.
    End point type
    Primary
    End point timeframe
    Up to 194 days
    End point values
    		 V116 Combined Lots 1, 2, and 3 PPSV23
    Number of subjects analysed
    1616
    541
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    Statistical analysis title
    		 Vaccine-related SAEs: V116 Combined Lots - PPSV23
    Statistical analysis description
    Estimated difference in percentage and 95% CI were based on the Miettinen & Nurminen method.
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Estimated difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 0.2

    Primary: Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with separate V116 lots

    		 Close Top of page
    End point title
    		 Geometric mean titers (GMTs) of serotype-specific opsonophagocytic activity (OPA) for all serotypes in V116 following vaccination with separate V116 lots
    End point description
    Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using multiplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. A value of 99999 indicates that no MOD were calculated. Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Primary
    End point timeframe
    Day 30
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    538
    540
    0 [7]
    Units: Titers
    geometric mean (confidence interval 95%)
        Serotype 3 (n=524, 525, 525)
    327.2 (-99999 to 99999)
    299.0 (-99999 to 99999)
    318.8 (-99999 to 99999)
    ( to )
        Serotype 6A (n=515, 523, 524)
    6901.9 (-99999 to 99999)
    6014.9 (-99999 to 99999)
    6641.2 (-99999 to 99999)
    ( to )
        Serotype 7F (n=522, 531, 527)
    7219.8 (-99999 to 99999)
    6201.8 (-99999 to 99999)
    6657.0 (-99999 to 99999)
    ( to )
        Serotype 8 (n=527, 530, 528)
    3935.5 (-99999 to 99999)
    3812.8 (-99999 to 99999)
    3765.8 (-99999 to 99999)
    ( to )
        Serotype 9N (n=526, 533, 531)
    18747.4 (-99999 to 99999)
    17201.6 (-99999 to 999999)
    18557.8 (-99999 to 99999)
    ( to )
        Serotype 10A (n=524, 529, 533)
    7570.2 (-99999 to 99999)
    7796.9 (-99999 to 99999)
    7330.4 (-99999 to 99999)
    ( to )
        Serotype 11A (n=518, 531, 532)
    6396.0 (-99999 to 99999)
    6630.9 (-99999 to 99999)
    6374.5 (-99999 to 99999)
    ( to )
        Serotype 12F (n=523, 532, 528)
    7478.5 (-99999 to 99999)
    6803.0 (-99999 to 99999)
    7329.9 (-99999 to 99999)
    ( to )
        Serotype 15A (n=502, 505, 513)
    10698.5 (-99999 to 99999)
    10253.9 (-99999 to 99999)
    10692.3 (-99999 to 99999)
    ( to )
        Serotype 15C (n=522, 527, 522)
    13133.8 (-99999 to 99999)
    11441.3 (-99999 to 99999)
    11177.1 (-99999 to 99999)
    ( to )
        Serotype 16F (n=521, 521, 521)
    9239.1 (-99999 to 99999)
    9550.8 (-99999 to 99999)
    9530.1 (-99999 to 99999)
    ( to )
        Serotype 17F (n=525, 531, 532)
    17185.3 (-99999 to 99999)
    17718.6 (-99999 to 99999)
    16886.7 (-99999 to 99999)
    ( to )
        Serotype 19A (n=527, 533, 533)
    3187.1 (-99999 to 99999)
    3123.3 (-99999 to 99999)
    3368.0 (-99999 to 99999)
    ( to )
        Serotype 20A (n=524, 525, 525)
    16339.3 (-99999 to 99999)
    16676.2 (-99999 to 99999)
    15302.4 (-99999 to 99999)
    ( to )
        Serotype 22F (n=521, 523, 529)
    11638.5 (-99999 to 99999)
    10614.3 (-99999 to 99999)
    11346.7 (-99999 to 99999)
    ( to )
        Serotype 23A (n=509, 521, 520)
    8437.4 (-99999 to 99999)
    8459.8 (-99999 to 99999)
    8322.8 (-99999 to 99999)
    ( to )
        Serotype 23B (n=526, 530, 527)
    2964.1 (-99999 to 99999)
    2435.5 (-99999 to 99999)
    3035.5 (-99999 to 99999)
    ( to )
        Serotype 24F (n=522, 522, 524)
    4861.3 (-99999 to 99999)
    4783.4 (-99999 to 99999)
    4758.8 (-99999 to 99999)
    ( to )
        Serotype 31 (n=516, 527, 522)
    9052.0 (-99999 to 99999)
    8831.6 (-99999 to 99999)
    8870.7 (-99999 to 99999)
    ( to )
        Serotype 33F (n=521, 529, 526)
    37994.1 (-99999 to 99999)
    34227.3 (-99999 to 99999)
    35182.5 (-99999 to 99999)
    ( to )
        Serotype 35B (n=523, 528, 527)
    12971.8 (-99999 to 99999)
    12586.6 (-99999 to 99999)
    12494.5 (-99999 to 99999)
    ( to )
    Notes
    [7] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    Statistical analysis title
    		 Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [8]
    P-value
    		 < 0.001 [9]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.24
    Notes
    [8] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [9] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 3: GMT Ratio V116 Lot 2/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [10]
    P-value
    		 < 0.001 [11]
    Method
    		 cLDA Model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.06
    Notes
    [10] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [11] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 3: GMT Ratio V116 Lot 1/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [12]
    P-value
    		 < 0.001 [13]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.17
    Notes
    [12] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [13] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [14]
    P-value
    		 < 0.001 [15]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.35
    Notes
    [14] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [15] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 6A: GMT Ratio V116 Lot 1/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [16]
    P-value
    		 < 0.001 [17]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.22
    Notes
    [16] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [17] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 7F: GMT Ratio V116 Lot 1/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [18]
    P-value
    		 < 0.001 [19]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.25
    Notes
    [18] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [19] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 6A: GMT Ratio V116 Lot 2/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [20]
    P-value
    		 < 0.001 [21]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.06
    Notes
    [20] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [21] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 7F: V116 Lot 1/ V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [22]
    P-value
    		 < 0.001 [23]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.34
    Notes
    [22] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [23] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 7F: GMT Ratio V116 Lot 2/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [24]
    P-value
    		 < 0.001 [25]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.07
    Notes
    [24] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [25] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 8 GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [26]
    P-value
    		 < 0.001 [27]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.16
    Notes
    [26] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [27] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [28]
    P-value
    		 < 0.001 [29]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.26
    Notes
    [28] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [29] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 8: GMT Ratio V116 Lot 2/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [30]
    P-value
    		 < 0.001 [31]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.14
    Notes
    [30] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [31] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 8: GMT Ratio V116 Lot 1/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [32]
    P-value
    		 < 0.001 [33]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.18
    Notes
    [32] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [33] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 9N: GMT Ratio V116 Lot 1/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [34]
    P-value
    		 < 0.001 [35]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.17
    Notes
    [34] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [35] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 10A: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [36]
    P-value
    		 < 0.001 [37]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.21
    Notes
    [36] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [37] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [38]
    P-value
    		 < 0.001 [39]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.18
    Notes
    [38] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [39] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 10A: GMT Ratio V116 Lot 1/ V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [40]
    P-value
    		 < 0.001 [41]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.11
    Notes
    [40] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [41] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 9N: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [42]
    P-value
    		 < 0.001 [43]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.07
    Notes
    [42] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [43] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 11A: GMT Ratio V116 Lot 1/ V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [44]
    P-value
    		 < 0.001 [45]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.11
    Notes
    [44] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [45] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 11A: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [46]
    P-value
    		 < 0.001 [47]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.16
    Notes
    [46] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [47] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 11A: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [48]
    P-value
    		 < 0.001 [49]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.2
    Notes
    [48] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [49] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [50]
    P-value
    		 < 0.001 [51]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.26
    Notes
    [50] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [51] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 15A: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [52]
    P-value
    		 < 0.001 [53]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.12
    Notes
    [52] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [53] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [54]
    P-value
    		 < 0.001 [55]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.22
    Notes
    [54] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [55] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 12F: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [56]
    P-value
    		 < 0.001 [57]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.07
    Notes
    [56] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [57] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 12F: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [58]
    P-value
    		 < 0.001 [59]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.17
    Notes
    [58] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [59] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 15A: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [60]
    P-value
    		 < 0.001 [61]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.17
    Notes
    [60] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [61] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [62]
    P-value
    		 < 0.001 [63]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.11
    Notes
    [62] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [63] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 15C: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [64]
    P-value
    		 < 0.001 [65]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.23
    Notes
    [64] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [65] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [66]
    P-value
    		 < 0.001 [67]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.42
    Notes
    [66] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [67] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 15C: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [68]
    P-value
    		 < 0.001 [69]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.38
    Notes
    [68] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [69] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 16F: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [70]
    P-value
    		 < 0.001 [71]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.11
    Notes
    [70] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [71] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [72]
    P-value
    		 < 0.001 [73]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.15
    Notes
    [72] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [73] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 17F: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [74]
    P-value
    		 < 0.001 [75]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.2
    Notes
    [74] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [75] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [76]
    P-value
    		 < 0.001 [77]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.17
    Notes
    [76] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [77] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 17F: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [78]
    P-value
    		 < 0.001 [79]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.11
    Notes
    [78] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [79] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 16F: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [80]
    P-value
    		 < 0.001 [81]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.15
    Notes
    [80] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [81] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 19A: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [82]
    P-value
    		 < 0.001 [83]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.04
    Notes
    [82] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [83] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 19A: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [84]
    P-value
    		 < 0.001 [85]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.07
    Notes
    [84] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [85] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [86]
    P-value
    		 < 0.001 [87]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.14
    Notes
    [86] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [87] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 20A: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [88]
    P-value
    		 < 0.001 [89]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.24
    Notes
    [88] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [89] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [90]
    P-value
    		 < 0.001 [91]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.19
    Notes
    [90] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [91] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [92]
    P-value
    		 < 0.001 [93]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.29
    Notes
    [92] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [93] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 22F: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [94]
    P-value
    		 < 0.001 [95]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.21
    Notes
    [94] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [95] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 22F: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [96]
    P-value
    		 < 0.001 [97]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.1
    Notes
    [96] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [97] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 23A: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [98]
    P-value
    		 < 0.001 [99]
    Method
    		 cDLA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.17
    Notes
    [98] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [99] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 20A: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [100]
    P-value
    		 < 0.001 [101]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.27
    Notes
    [100] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [101] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [102]
    P-value
    		 < 0.001 [103]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.48
    Notes
    [102] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [103] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 23A: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [104]
    P-value
    		 < 0.001 [105]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.19
    Notes
    [104] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [105] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 23B: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [106]
    P-value
    		 < 0.001 [107]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.19
    Notes
    [106] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [107] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 31: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [108]
    P-value
    		 < 0.001 [109]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.17
    Notes
    [108] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [109] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [110]
    P-value
    		 < 0.001 [111]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.2
    Notes
    [110] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [111] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 31: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [112]
    P-value
    		 < 0.001 [113]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.2
    Notes
    [112] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [113] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 24F: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [114]
    P-value
    		 < 0.001 [115]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.16
    Notes
    [114] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [115] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [116]
    P-value
    		 < 0.001 [117]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.18
    Notes
    [116] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [117] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 23B: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [118]
    P-value
    		 < 0.001 [119]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.97
    Notes
    [118] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [119] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 24F: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [120]
    P-value
    		 < 0.001 [121]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.18
    Notes
    [120] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [121] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 33F: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [122]
    P-value
    		 < 0.001 [123]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.16
    Notes
    [122] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [123] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [124]
    P-value
    		 < 0.001 [125]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.17
    Notes
    [124] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [125] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 35B: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [126]
    P-value
    		 < 0.001 [127]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.18
    Notes
    [126] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [127] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 2
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [128]
    P-value
    		 < 0.001 [129]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.33
    Notes
    [128] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [129] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 33F: GMT Ratio V116 Lot 1/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [130]
    P-value
    		 < 0.001 [131]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.29
    Notes
    [130] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [131] - Identical p-values for the lower and upper bounds.
    Statistical analysis title
    		 Serotype 35B: GMT Ratio V116 Lot 2/V116 Lot 3
    Statistical analysis description
    Equivalence can be concluded if both the lower tailed and upper tailed p-values are < 0.025.
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [132]
    P-value
    		 < 0.001 [133]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.14
    Notes
    [132] - P value for testing the lower bound of the 95% CI for GMT ratio was >0.5. P value for testing the upper bound of the 95% CI for GMT ratio was <2.0.
    [133] - Identical p-values for the lower and upper bounds.

    Secondary: GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PPSV23

    		 Close Top of page
    End point title
    		 GMTs of serotype-specific OPA for all serotypes in V116 following vaccination: combined lots of V116 or PPSV23
    End point description
    Serotype-specific OPA titers for all serotypes in V116 following vaccination were determined using MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CI were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated and a value of 99999 means that no MOD was calculated. All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 PPSV23 V116 Combined Lots 1, 2, and 3
    Number of subjects analysed
    541
    1617
    Units: Titers
    geometric mean (confidence interval 95%)
        Serotype 3 (n= 1574, 534)
    339.8 (-99999 to 99999)
    316.5 (-99999 to 99999)
        Serotype 6A (n= 1562, 529)
    1866.4 (-99999 to 99999)
    6491.7 (-99999 to 99999)
        Serotype 7F (n= 1580, 531)
    5058.1 (-99999 to 99999)
    6702.2 (-99999 to 99999)
        Serotype 8 (n= 1585, 537)
    4543.3 (-99999 to 99999)
    3847.3 (-99999 to 99999)
        Serotype 9N (n= 1590, 533)
    19031.9 (-99999 to 99999)
    18166.7 (-99999 to 99999)
        Serotype 10A (n= 1586, 534)
    5763.0 (-99999 to 99999)
    7618.2 (-99999 to 99999)
        Serotype 11A (n= 1581, 534)
    3728.0 (-99999 to 99999)
    6494.4 (-99999 to 99999)
        Serotype 12F (n= 1583, 534)
    5207.5 (-99999 to 99999)
    7196.9 (-99999 to 99999)
        Serotype 15A (n= 1520, 512)
    2608.5 (-99999 to 99999)
    10520.0 (-99999 to 99999)
        Serotype 15C (n= 1571, 529)
    4112.0 (-99999 to 99999)
    11922.3 (-99999 to 99999)
        Serotype 16F (n= 1563, 527)
    2532.2 (-99999 to 99999)
    9415.3 (-99999 to 99999)
        Serotype 17F (n= 1588, 536)
    10159.9 (-99999 to 99999)
    17330.5 (-99999 to 99999)
        Serotype 19A (n= 1593, 533)
    3474.7 (-99999 to 99999)
    3222.9 (-99999 to 99999)
        Serotype 20A (n= 1574, 533)
    10994.2 (-99999 to 99999)
    16183.8 (-99999 to 99999)
        Serotype 22F (n= 1573, 530)
    8308.0 (-99999 to 99999)
    11118.1 (-99999 to 99999)
        Serotype 23A (n= 1550, 519)
    1056.1 (-99999 to 99999)
    8428.3 (-99999 to 99999)
        Serotype 23B (n= 1583, 533)
    119.1 (-99999 to 99999)
    2825.4 (-99999 to 99999)
        Serotype 24F (n= 1568, 518)
    250.3 (-99999 to 99999)
    4892.9 (-99999 to 99999)
        Serotype 31 (n= 1565, 531)
    654.5 (-99999 to 99999)
    8865.6 (-99999 to 99999)
        Serotype 33F (n= 1576, 533)
    42515.6 (-99999 to 99999)
    35684.3 (-99999 to 99999)
        Serotype 35B (n= 1578, 537)
    3452.1 (-99999 to 99999)
    12798.6 (-99999 to 99999)
    Statistical analysis title
    		 Serotype 7F: GMT Ratio V116 Combined Lots / PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [134]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 1.49
    Notes
    [134] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [135]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    3.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.01
         upper limit
    		 4.02
    Notes
    [135] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3: GMT Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [136]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.03
    Notes
    [136] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 8: GMT Ratio V116 Combined Lots / PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [137]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.93
    Notes
    [137] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9N: GMT Ratio V116 Combined Lots / PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [138]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.08
    Notes
    [138] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 10A: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [139]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 1.48
    Notes
    [139] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 11A: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [140]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.56
         upper limit
    		 1.95
    Notes
    [140] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15C: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [141]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.49
         upper limit
    		 3.38
    Notes
    [141] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15A: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [142]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    4.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.56
         upper limit
    		 4.56
    Notes
    [142] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 12F: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [143]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.22
         upper limit
    		 1.56
    Notes
    [143] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 16F: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [144]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    3.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.32
         upper limit
    		 4.17
    Notes
    [144] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 17F: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [145]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.53
         upper limit
    		 1.91
    Notes
    [145] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [146]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.03
    Notes
    [146] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 20A: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [147]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 1.67
    Notes
    [147] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [148]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 1.53
    Notes
    [148] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23A: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [149]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    7.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.84
         upper limit
    		 9.31
    Notes
    [149] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23B: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [150]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    23.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.71
         upper limit
    		 28.55
    Notes
    [150] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 24F: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [151]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    19.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.7
         upper limit
    		 22.88
    Notes
    [151] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 31: GMT Ratio V116 Combined Lots / PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [152]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    13.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.68
         upper limit
    		 15.71
    Notes
    [152] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [153]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 0.97
    Notes
    [153] - GMT Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 35B: GMT Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2158
    Analysis specification
    Pre-specified
    Analysis type
    		 other [154]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    3.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.36
         upper limit
    		 4.09
    Notes
    [154] - GMT Ratio and 95% CI were estimated from a cLDA model.

    Secondary: Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots

    		 Close Top of page
    End point title
    		 Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) for all serotypes in V116 following vaccination with separate V116 lots
    End point description
    Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated and the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. A value of 99999 indicates that no MOD were calculated. Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    538
    540
    0 [155]
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 3 (n=532, 535, 536)
    0.83 (-99999 to 99999)
    0.85 (-99999 to 99999)
    0.87 (-99999 to 99999)
    ( to )
        Serotype 6A (n=532, 535, 536)
    5.94 (-99999 to 99999)
    5.29 (-99999 to 99999)
    5.84 (-99999 to 99999)
    ( to )
        Serotype 7F (n=532, 535, 536)
    5.13 (-99999 to 99999)
    5.29 (-99999 to 99999)
    4.99 (-99999 to 99999)
    ( to )
        Serotype 8 (n=532, 535, 536)
    10.32 (-99999 to 99999)
    10.52 (-99999 to 99999)
    10.42 (-99999 to 99999)
    ( to )
        Serotype 9N (n=532, 535, 536)
    5.37 (-99999 to 99999)
    5.11 (-99999 to 99999)
    6.03 (-99999 to 99999)
    ( to )
        Serotype 10A (n=532, 535, 536)
    9.63 (-99999 to 99999)
    9.52 (-99999 to 99999)
    9.97 (-99999 to 99999)
    ( to )
        Serotype 11A (n=532, 535, 536)
    6.33 (-99999 to 99999)
    6.28 (-99999 to 99999)
    6.21 (-99999 to 99999)
    ( to )
        Serotype 12F (n=532, 535, 536)
    1.65 (-99999 to 99999)
    1.75 (-99999 to 99999)
    1.65 (-99999 to 99999)
    ( to )
        Serotype 15A (n=532, 535, 536)
    13.63 (-99999 to 99999)
    13.00 (-99999 to 99999)
    14.20 (-99999 to 99999)
    ( to )
        Serotype 15C (n=532, 535, 536)
    14.32 (-99999 to 99999)
    13.54 (-99999 to 99999)
    13.85 (-99999 to 99999)
    ( to )
        Serotype 16F (n=532, 535, 536)
    1.77 (-99999 to 99999)
    1.97 (-99999 to 99999)
    1.96 (-99999 to 99999)
    ( to )
        Serotype 17F (n=532, 535, 536)
    14.05 (-99999 to 99999)
    13.37 (-99999 to 99999)
    13.14 (-99999 to 99999)
    ( to )
        Serotype 19A (n=532, 535, 536)
    7.70 (-99999 to 99999)
    7.94 (-99999 to 99999)
    8.51 (-99999 to 99999)
    ( to )
        Serotype 20A (n=532, 535, 536)
    13.54 (-99999 to 99999)
    14.18 (-99999 to 99999)
    14.09 (-99999 to 99999)
    ( to )
        Serotype 22F (n=532, 535, 536)
    7.02 (-99999 to 99999)
    6.97 (-99999 to 99999)
    6.99 (-99999 to 99999)
    ( to )
        Serotype 23A (n=532, 535, 536)
    4.26 (-99999 to 99999)
    4.34 (-99999 to 99999)
    4.34 (-99999 to 99999)
    ( to )
        Serotype 23B (n=532, 535, 536)
    6.77 (-99999 to 99999)
    6.65 (-99999 to 99999)
    7.39 (-99999 to 99999)
    ( to )
        Serotype 24F (n=532, 535, 536)
    4.32 (-99999 to 99999)
    4.55 (-99999 to 99999)
    4.34 (-99999 to 99999)
    ( to )
        Serotype 31 (n=532, 535, 536)
    3.47 (-99999 to 99999)
    3.94 (-99999 to 99999)
    3.47 (-99999 to 99999)
    ( to )
        Serotype 33F (n=532, 535, 536)
    8.03 (-99999 to 99999)
    7.94 (-99999 to 99999)
    8.00 (-99999 to 99999)
    ( to )
        Serotype 35B (n=532, 535, 536)
    11.84 (-99999 to 99999)
    11.56 (-99999 to 99999)
    11.94 (-99999 to 99999)
    ( to )
    Notes
    [155] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    Statistical analysis title
    		 Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [156]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.11
    Notes
    [156] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A: GMC Ratio V116 Lot 2/ V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [157]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.07
    Notes
    [157] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [158]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.2
    Notes
    [158] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A: GMC Ratio V116 Lot 1/ V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [159]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.32
    Notes
    [159] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3: GMC Ratio V116 Lot 2/ V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [160]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.08
    Notes
    [160] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [161]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.05
    Notes
    [161] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 3: GMC Ratio V116 Lot 1/ V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [162]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.09
    Notes
    [162] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [163]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.03
    Notes
    [163] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9N: GMC Ratio V116 Lot 1/ V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [164]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.21
    Notes
    [164] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 8: GMC Ratio V116 Lot 2/ V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [165]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.15
    Notes
    [165] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [166]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.13
    Notes
    [166] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 8: GMC Ratio V116 Lot 1/ V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [167]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.12
    Notes
    [167] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F: GMC Ratio V116 Lot 2/ V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [168]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.21
    Notes
    [168] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F: GMC Ratio V116 Lot 1/ V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [169]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.18
    Notes
    [169] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9N: GMC Ratio V116 Lot 2/ V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [170]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.98
    Notes
    [170] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 11A: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [171]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.14
    Notes
    [171] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 10A: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [172]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.11
    Notes
    [172] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 10A: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [173]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.13
    Notes
    [173] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 10A: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [174]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.18
    Notes
    [174] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 11A: GMC Ratio V116 Lot 1/ V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [175]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.15
    Notes
    [175] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 11A: GMC Ratio V116 Lot 2/ V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [176]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.14
    Notes
    [176] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 12F: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [177]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.12
    Notes
    [177] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 12F: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [178]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.18
    Notes
    [178] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 12F: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [179]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.25
    Notes
    [179] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15C: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [180]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.14
    Notes
    [180] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15C: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [181]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.2
    Notes
    [181] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15C: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [182]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.23
    Notes
    [182] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15A: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [183]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.05
    Notes
    [183] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15A: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [184]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.11
    Notes
    [184] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15A: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [185]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.21
    Notes
    [185] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 16F: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [186]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.03
    Notes
    [186] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 16F: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [187]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.04
    Notes
    [187] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 20A: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [188]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.1
    Notes
    [188] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [189]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.07
    Notes
    [189] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [190]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.04
    Notes
    [190] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [191]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.11
    Notes
    [191] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 17F: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [192]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.17
    Notes
    [192] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 17F: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [193]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.23
    Notes
    [193] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 17F: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [194]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.21
    Notes
    [194] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 16F: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [195]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.15
    Notes
    [195] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 20A: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [196]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.16
    Notes
    [196] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 20A: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [197]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.1
    Notes
    [197] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [198]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.16
    Notes
    [198] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [199]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.16
    Notes
    [199] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23B: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [200]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.18
    Notes
    [200] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23A: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [201]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.16
    Notes
    [201] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23A: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [202]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.15
    Notes
    [202] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23A: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [203]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.17
    Notes
    [203] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [204]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.15
    Notes
    [204] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23B: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [205]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.05
    Notes
    [205] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23B: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [206]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.07
    Notes
    [206] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 24F: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [207]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.13
    Notes
    [207] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 31: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [208]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1
    Notes
    [208] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 31: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [209]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.14
    Notes
    [209] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 31: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [210]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.3
    Notes
    [210] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 24F: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [211]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.19
    Notes
    [211] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 24F: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [212]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.25
    Notes
    [212] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [213]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.15
    Notes
    [213] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F: GMC Ratio V116 Lot 1/V116 Lot 2
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [214]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.16
    Notes
    [214] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 35B: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 3
    Number of subjects included in analysis
    1079
    Analysis specification
    Pre-specified
    Analysis type
    		 other [215]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.13
    Notes
    [215] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [216]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.13
    Notes
    [216] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 35B: GMC Ratio V116 Lot 1/V116 Lot 3
    Comparison groups
    V116 Lot 1 v V116 Lot 2
    Number of subjects included in analysis
    1077
    Analysis specification
    Pre-specified
    Analysis type
    		 other [217]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.17
    Notes
    [217] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 35B: GMC Ratio V116 Lot 2/V116 Lot 3
    Comparison groups
    V116 Lot 2 v V116 Lot 3
    Number of subjects included in analysis
    1078
    Analysis specification
    Pre-specified
    Analysis type
    		 other [218]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.1
    Notes
    [218] - GMC Ratio and 95% CI were estimated from a cLDA model.

    Secondary: GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PPSV23

    		 Close Top of page
    End point title
    		 GMCs of serotype-specific IgG for all serotypes in V116 following vaccination: combined lots of V116 or PPSV23
    End point description
    Serotype-specific IgG concentrations for all serotypes in V116 following vaccination were determined using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated and a value of 99999 means that no MOD were calculated. All randomized participants without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V116 Combined Lots 1, 2, and 3 PPSV23
    Number of subjects analysed
    1617
    540
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 3 (n=1603, 539)
    0.85 (-99999 to 99999)
    0.77 (-99999 to 99999)
        Serotype 6A (n=1603, 539)
    5.67 (-99999 to 99999)
    1.45 (-99999 to 99999)
        Serotype 7F (n=1603, 539)
    5.19 (-99999 to 99999)
    3.36 (-99999 to 99999)
        Serotype 8 (n=1603, 539)
    10.34 (-99999 to 99999)
    12.85 (-99999 to 99999)
        Serotype 9N (n=1603, 539)
    5.51 (-99999 to 99999)
    5.41 (-99999 to 99999)
        Serotype 10A (n=1603, 539)
    9.58 (-99999 to 99999)
    6.52 (-99999 to 99999)
        Serotype 11A (n=1603, 539)
    6.29 (-99999 to 99999)
    4.55 (-99999 to 99999)
        Serotype 12F (n=1603, 539)
    1.69 (-99999 to 99999)
    1.20 (-99999 to 99999)
        Serotype 15A (n=1603, 539)
    13.55 (-99999 to 99999)
    1.99 (-99999 to 99999)
        Serotype 15C (n=1603, 539)
    13.90 (-99999 to 99999)
    4.29 (-99999 to 99999)
        Serotype 16F (n=1603, 539)
    1.91 (-99999 to 99999)
    0.30 (-99999 to 99999)
        Serotype 17F (n=1603, 539)
    13.46 (-99999 to 99999)
    7.28 (-99999 to 99999)
        Serotype 19A (n=1603, 539)
    8.01 (-99999 to 99999)
    7.29 (-99999 to 99999)
        Serotype 20A (n=1603, 539)
    13.82 (-99999 to 99999)
    9.03 (-99999 to 99999)
        Serotype 22F (n=1603, 539)
    7.04 (-99999 to 99999)
    5.34 (-99999 to 99999)
        Serotype 23A (n=1603, 539)
    4.29 (-99999 to 99999)
    0.53 (-99999 to 99999)
        Serotype 23B (n=1603, 539)
    6.96 (-99999 to 99999)
    1.21 (-99999 to 99999)
        Serotype 24F (n=1603, 539)
    4.44 (-99999 to 99999)
    0.31 (-99999 to 99999)
        Serotype 31 (n=1603, 539)
    3.62 (-99999 to 99999)
    0.38 (-99999 to 99999)
        Serotype 33F (n=1603, 539)
    8.00 (-99999 to 99999)
    9.82 (-99999 to 99999)
        Serotype 35B (n=1603, 539)
    11.71 (-99999 to 99999)
    1.66 (-99999 to 99999)
    Statistical analysis title
    		 Serotype 3: GMC Ratio V116 Combined Lots/PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [219]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.21
    Notes
    [219] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 7F: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [220]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.38
         upper limit
    		 1.72
    Notes
    [220] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 6A: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [221]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    3.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.43
         upper limit
    		 4.45
    Notes
    [221] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 11A: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [222]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 1.52
    Notes
    [222] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 12F: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [223]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 1.62
    Notes
    [223] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15A: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [224]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    6.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.08
         upper limit
    		 7.65
    Notes
    [224] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 15C: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [225]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    3.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.86
         upper limit
    		 3.67
    Notes
    [225] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 10A: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [226]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 1.66
    Notes
    [226] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 9N: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [227]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.14
    Notes
    [227] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 8: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [228]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 0.89
    Notes
    [228] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 16F: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [229]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    6.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.83
         upper limit
    		 7.19
    Notes
    [229] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 19A: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [230]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.22
    Notes
    [230] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 17F: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [231]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.66
         upper limit
    		 2.07
    Notes
    [231] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 20A: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [232]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 1.71
    Notes
    [232] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 22F: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [233]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.17
         upper limit
    		 1.49
    Notes
    [233] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23A: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [234]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    8.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.19
         upper limit
    		 9.23
    Notes
    [234] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 23B: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [235]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    5.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.08
         upper limit
    		 6.48
    Notes
    [235] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 24F: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [236]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    14.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.77
         upper limit
    		 16.4
    Notes
    [236] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 33F: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [237]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 0.91
    Notes
    [237] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 31: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [238]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    9.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.61
         upper limit
    		 10.59
    Notes
    [238] - GMC Ratio and 95% CI were estimated from a cLDA model.
    Statistical analysis title
    		 Serotype 35B: GMC Ratio V116 Combined Lots/ PPSV23
    Comparison groups
    V116 Combined Lots 1, 2, and 3 v PPSV23
    Number of subjects included in analysis
    2157
    Analysis specification
    Pre-specified
    Analysis type
    		 other [239]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    7.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.41
         upper limit
    		 7.77
    Notes
    [239] - GMC Ratio and 95% CI were estimated from a cLDA model.

    Secondary: Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots

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    End point title
    		 Geometric mean fold rise (GMFR) in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots
    End point description
    Serotype-specific OPA GMFR for all serotypes in V116 following vaccination were determined using MOPA. The GMFR of each pneumococcal serotype was calculated as Day 30 GMT/Day 1 GMT. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Day 30
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    538
    540
    0 [240]
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 3 (n=413, 427, 429)
    8.2 (7.2 to 9.4)
    8.1 (7.2 to 9.1)
    8.2 (7.3 to 9.3)
    ( to )
        Serotype 6A (n=366, 393, 403)
    46.8 (38.5 to 56.8)
    37.8 (31.1 to 45.9)
    35.8 (29.7 to 43.2)
    ( to )
        Serotype 7F (n=438, 435, 428)
    17.6 (14.6 to 21.2)
    14.2 (11.8 to 17.0)
    14.8 (12.4 to 17.6)
    ( to )
        Serotype 8 (n=450, 456, 466)
    17.6 (14.7 to 21.1)
    16.2 (13.6 to 19.2)
    15.4 (12.9 to 18.5)
    ( to )
        Serotype 9N (n=438, 439, 434)
    10.1 (8.8 to 11.7)
    10.4 (9.0 to 12.0)
    10.5 (9.0 to 12.2)
    ( to )
        Serotype 10A (n=432, 450, 458)
    14.1 (11.8 to 16.7)
    15.2 (12.8 to 18.0)
    15.9 (13.3 to 18.9)
    ( to )
        Serotype 11A (n=428, 432, 450)
    11.5 (9.5 to 14.0)
    11.3 (9.3 to 13.8)
    9.3 (7.8 to 11.1)
    ( to )
        Serotype 12F (n=433, 457, 432)
    173.7 (144.8 to 208.5)
    152.0 (127.5 to 181.2)
    194.1 (162.5 to 231.7)
    ( to )
        Serotype 15A (n=305, 325, 320)
    9.3 (7.8 to 11.2)
    8.8 (7.5 to 10.5)
    9.5 (7.9 to 11.3)
    ( to )
        Serotype 15C (n=391, 411, 393)
    86.0 (68.7 to 107.8)
    78.8 (64.0 to 97.0)
    63.8 (51.2 to 79.5)
    ( to )
        Serotype 16F (n=382, 402, 403)
    7.1 (6.2 to 8.2)
    7.6 (6.6 to 8.8)
    6.9 (6.2 to 7.8)
    ( to )
        Serotype 17F (n=445, 457, 458)
    17.8 (15.3 to 20.9)
    18.5 (15.8 to 21.6)
    16.9 (14.4 to 19.8)
    ( to )
        Serotype 19A (n=446, 468, 468)
    8.9 (7.7 to 10.3)
    8.5 (7.4 to 9.9)
    8.9 (7.8 to 10.3)
    ( to )
        Serotype 20A (n=376, 396, 403)
    10.6 (9.1 to 12.3)
    11.7 (10.2 to 13.4)
    9.5 (8.3 to 10.8)
    ( to )
        Serotype 22F (n=409, 404, 417)
    20.0 (16.1 to 24.7)
    15.4 (12.6 to 18.8)
    18.1 (14.9 to 22.0)
    ( to )
        Serotype 23A (n=344, 373, 357)
    30.9 (24.8 to 38.4)
    27.7 (22.6 to 34.1)
    30.0 (24.5 to 36.7)
    ( to )
        Serotype 23B (n=428, 448, 444)
    104.1 (85.2 to 127.2)
    91.0 (74.5 to 111.2)
    106.0 (87.2 to 128.8)
    ( to )
        Serotype 24F (n=383, 399, 407)
    27.0 (22.2 to 32.9)
    24.0 (19.6 to 29.2)
    25.4 (20.8 to 31.0)
    ( to )
        Serotype 31 (n=383, 406, 398)
    25.1 (20.3 to 31.2)
    25.7 (20.9 to 31.6)
    21.2 (17.2 to 26.1)
    ( to )
        Serotype 33F (n=393, 411, 425)
    13.1 (11.2 to 15.2)
    12.5 (10.7 to 14.5)
    12.3 (10.6 to 14.2)
    ( to )
        Serotype 35B (n=420, 434, 441)
    4.6 (4.1 to 5.2)
    5.0 (4.4 to 5.7)
    4.7 (4.1 to 5.3)
    ( to )
    Notes
    [240] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Secondary: Percentage of participants with ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots

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    End point title
    		 Percentage of participants with ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination with separate V116 Lots
    End point description
    Serotype-specific OPA titer were determined using MOPA. The percentage of participants with a ≥4-fold rise in serotype-specific OPA for all serotypes in V116 following vaccination were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Day 30
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    538
    540
    0 [241]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 3 (n=413, 427, 429)
    70.7 (66.1 to 75.1)
    71.0 (66.4 to 75.2)
    70.6 (66.1 to 74.9)
    ( to )
        Serotype 6A (n=366, 393, 403)
    87.2 (83.3 to 90.4)
    86.5 (82.7 to 89.7)
    85.6 (81.8 to 88.9)
    ( to )
        Serotype 7F (n=438, 435, 428)
    73.5 (69.1 to 77.6)
    69.7 (65.1 to 73.9)
    71.7 (67.2 to 75.9)
    ( to )
        Serotype 8 (n=450, 456, 458)
    72.7 (68.3 to 76.7)
    75.9 (71.7 to 79.7)
    70.4 (66.0 to 74.5)
    ( to )
        Serotype 9N (n=438, 439, 434)
    69.6 (65.1 to 73.9)
    70.4 (65.9 to 74.6)
    72.1 (67.6 to 76.3)
    ( to )
        Serotype 10A (n=432, 450, 458)
    70.6 (66.1 to 74.9)
    75.1 (70.8 to 79.0)
    73.8 (69.5 to 77.8)
    ( to )
        Serotype 11A (n=428, 432, 450)
    64.3 (59.5 to 68.8)
    66.0 (61.3 to 70.4)
    61.3 (56.7 to 65.9)
    ( to )
        Serotype 12F (n=433, 457, 432)
    94.5 (91.9 to 96.4)
    94.5 (92.0 to 96.4)
    95.6 (93.2 to 97.3)
    ( to )
        Serotype 15A (n=305, 325, 320)
    66.9 (61.3 to 72.1)
    66.2 (60.7 to 71.3)
    67.5 (62.1 to 72.6)
    ( to )
        Serotype 15C (n=391, 411, 393)
    87.5 (83.8 to 90.6)
    90.3 (87.0 to 93.0)
    88.3 (84.7 to 91.3)
    ( to )
        Serotype 16F (n=382, 402, 403)
    66.0 (61.0 to 70.7)
    63.7 (58.8 to 68.4)
    62.5 (57.6 to 67.3)
    ( to )
        Serotype 17F (n=445, 457, 458)
    82.0 (78.1 to 85.5)
    81.4 (77.5 to 84.9)
    80.8 (76.9 to 84.3)
    ( to )
        Serotype 19A (n=446, 468, 468)
    65.2 (60.6 to 69.7)
    65.0 (60.4 to 69.3)
    66.2 (61.8 to 70.5)
    ( to )
        Serotype 20A (n=376, 396, 403)
    72.3 (67.5 to 76.8)
    77.8 (73.4 to 81.8)
    72.7 (68.1 to 77.0)
    ( to )
        Serotype 22F (n=409, 404, 417)
    76.3 (71.9 to 80.3)
    73.3 (68.7 to 77.5)
    78.4 (74.2 to 82.3)
    ( to )
        Serotype 23A (n=344, 373, 357)
    79.7 (75.0 to 83.8)
    79.4 (74.9 to 83.4)
    82.1 (77.7 to 85.9)
    ( to )
        Serotype 23B (n=428, 448, 444)
    91.4 (88.3 to 93.8)
    89.3 (86.0 to 92.0)
    90.3 (87.2 to 92.9)
    ( to )
        Serotype 24F (n=383, 399, 407)
    78.9 (74.4 to 82.8)
    78.2 (73.8 to 82.2)
    76.7 (72.2 to 80.7)
    ( to )
        Serotype 31 (n=383, 406, 398)
    78.3 (73.9 to 82.4)
    79.1 (74.8 to 82.9)
    77.6 (73.2 to 81.6)
    ( to )
        Serotype 33F (n=413, 427, 429)
    75.3 (70.7 to 79.5)
    73.2 (68.7 to 77.5)
    75.1 (70.7 to 79.1)
    ( to )
        Serotype 35B (n=420, 434, 441)
    52.9 (48.0 to 57.7)
    49.5 (44.7 to 54.3)
    48.5 (43.8 to 53.3)
    ( to )
    Notes
    [241] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Secondary: GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots

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    End point title
    		 GMFR in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots
    End point description
    Serotype-specific IgG GMFR for all serotypes in V116 following vaccination were determined using PnECL. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC. The 95% CIs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Day 30
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    538
    540
    0 [242]
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 3 (n=494, 502, 506)
    4.4 (4.0 to 4.8)
    4.7 (4.3 to 5.2)
    4.6 (4.1 to 5.0)
    ( to )
        Serotype 6A (n=493, 502, 506)
    21.2 (18.7 to 24.1)
    18.8 (16.6 to 21.5)
    21.0 (18.7 to 23.7)
    ( to )
        Serotype 7F (n=493, 502, 506)
    13.7 (12.3 to 15.2)
    13.4 (12.1 to 14.8)
    12.6 (11.3 to 14.0)
    ( to )
        Serotype 8 (n=493, 502, 506)
    14.3 (12.7 to 16.2)
    15.2 (13.5 to 17.0)
    14.5 (12.8 to 16.4)
    ( to )
        Serotype 9N (n=493, 502, 505)
    15.9 (14.3 to 17.8)
    15.3 (13.6 to 17.3)
    17.1 (15.2 to 19.3)
    ( to )
        Serotype 10A (n=494, 501, 506)
    15.0 (13.4 to 16.8)
    15.2 (13.5 to 17.1)
    15.7 (14.0 to 17.6)
    ( to )
        Serotype 11A (n=494, 502, 506)
    7.2 (6.5 to 8.0)
    7.2 (6.5 to 8.0)
    7.0 (6.3 to 7.8)
    ( to )
        Serotype 12F (n=494, 502, 505)
    16.3 (14.4 to 18.4)
    17.1 (15.1 to 19.3)
    15.8 (14.1 to 17.8)
    ( to )
        Serotype 15A (n=492, 502, 505)
    23.1 (20.6 to 25.9)
    22.8 (20.4 to 25.5)
    23.4 (20.9 to 26.3)
    ( to )
        Serotype 15C (n=494, 502, 505)
    28.5 (25.3 to 32.2)
    27.8 (24.7 to 31.3)
    27.3 (24.2 to 30.9)
    ( to )
        Serotype 16F (n=493, 502, 505)
    8.4 (7.6 to 9.3)
    8.8 (7.9 to 9.9)
    9.1 (8.2 to 10.1)
    ( to )
        Serotype 17F (n=494, 502, 506)
    23.5 (21.0 to 26.3)
    23.1 (20.6 to 25.9)
    21.5 (19.2 to 24.1)
    ( to )
        Serotype 19A (n=494, 502, 506)
    5.5 (4.9 to 6.1)
    5.8 (5.2 to 6.4)
    6.0 (5.4 to 6.7)
    ( to )
        Serotype 20A (n=494, 502, 504)
    9.2 (8.3 to 10.3)
    9.8 (8.8 to 10.9)
    9.8 (8.8 to 10.9)
    ( to )
        Serotype 22F (n=493, 502, 506)
    20.4 (17.9 to 23.3)
    19.1 (16.6 to 22.0)
    19.4 (17.0 to 22.2)
    ( to )
        Serotype 23A (n=492, 502, 504)
    20.3 (18.0 to 22.8)
    20.1 (17.9 to 22.5)
    20.3 (18.0 to 22.9)
    ( to )
        Serotype 23B (n=492, 502, 505)
    13.9 (12.2 to 15.7)
    14.0 (12.2 to 16.0)
    15.0 (13.2 to 17.1)
    ( to )
        Serotype 24F (n=492, 502, 506)
    14.7 (13.0 to 16.6)
    15.4 (13.6 to 17.5)
    14.6 (12.9 to 16.6)
    ( to )
        Serotype 31 (n=492, 502, 505)
    13.6 (12.3 to 15.0)
    15.7 (14.1 to 17.5)
    13.0 (11.7 to 14.5)
    ( to )
        Serotype 33F (n=494, 502, 505)
    8.8 (7.9 to 9.8)
    9.1 (8.2 to 10.1)
    9.1 (8.2 to 10.0)
    ( to )
        Serotype 35B (n=494, 502, 505)
    7.3 (6.5 to 8.1)
    7.3 (6.6 to 8.1)
    7.2 (6.5 to 8.0)
    ( to )
    Notes
    [242] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Secondary: Percentage of participants with ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots

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    End point title
    		 Percentage of participants with ≥4-fold rise in serotype-specific IgG for all serotypes in V116 following vaccination with separate V116 Lots
    End point description
    Serotype-specific IgG concentrations were determined using PnECL. The percentage of participants with a ≥4-fold rise in serotype-specific IgG for all serotypes in V116 were reported. The 95% CIs were calculated based on the exact binomial method proposed by Clopper and Pearson. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Day 30
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    538
    540
    0 [243]
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 3 (n=494, 502, 506)
    51.8 (47.3 to 56.3)
    54.4 (49.9 to 58.8)
    52.0 (47.5 to 56.4)
    ( to )
        Serotype 6A (n=493, 502, 506)
    87.8 (84.6 to 90.6)
    85.3 (81.9 to 88.2)
    89.3 (86.3 to 91.9)
    ( to )
        Serotype 7F (n=493, 502, 506)
    83.2 (79.6 to 86.4)
    84.1 (80.6 to 87.2)
    82.6 (79.0 to 85.8)
    ( to )
        Serotype 8 (n=493, 502, 506)
    80.5 (76.8 to 83.9)
    82.7 (79.1 to 85.9)
    81.4 (77.8 to 84.7)
    ( to )
        Serotype 9N (n=493, 502, 505)
    86.0 (82.6 to 88.9)
    84.1 (80.6 to 87.2)
    82.8 (79.2 to 86.0)
    ( to )
        Serotype 10A (n=494, 501, 506)
    82.8 (79.2 to 86.0)
    82.4 (78.8 to 85.7)
    83.4 (79.9 to 86.5)
    ( to )
        Serotype 11A (n=494, 502, 506)
    67.4 (63.1 to 71.5)
    67.3 (63.0 to 71.4)
    63.8 (59.5 to 68.0)
    ( to )
        Serotype 12F (n=494, 502, 505)
    83.8 (80.3 to 86.9)
    85.1 (81.6 to 88.1)
    84.4 (80.9 to 87.4)
    ( to )
        Serotype 15A (n=492, 502, 505)
    91.1 (88.2 to 93.4)
    89.2 (86.2 to 91.8)
    90.3 (87.4 to 92.7)
    ( to )
        Serotype 15C (n=494, 502, 505)
    90.9 (88.0 to 93.3)
    90.8 (88.0 to 93.2)
    90.1 (87.2 to 92.6)
    ( to )
        Serotype 16F (n=493, 502, 505)
    73.2 (69.1 to 77.1)
    72.5 (68.4 to 76.4)
    74.7 (70.6 to 78.4)
    ( to )
        Serotype 17F (n=494, 502, 506)
    90.3 (87.3 to 92.7)
    91.0 (88.2 to 93.4)
    87.7 (84.6 to 90.5)
    ( to )
        Serotype 19A (n=494, 502, 506)
    58.5 (54.0 to 62.9)
    58.6 (54.1 to 62.9)
    59.3 (54.9 to 63.6)
    ( to )
        Serotype 20A (n=494, 502, 504)
    72.9 (68.7 to 76.7)
    76.1 (72.1 to 79.8)
    74.8 (70.8 to 78.5)
    ( to )
        Serotype 22F (n=493, 502, 506)
    84.2 (80.7 to 87.3)
    79.5 (75.7 to 82.9)
    84.2 (80.7 to 87.3)
    ( to )
        Serotype 23A (n=492, 502, 504)
    89.0 (85.9 to 91.6)
    88.8 (85.8 to 91.5)
    86.3 (83.0 to 89.2)
    ( to )
        Serotype 23B (n=492, 502, 505)
    77.6 (73.7 to 81.2)
    77.1 (73.2 to 80.7)
    78.6 (74.8 to 82.1)
    ( to )
        Serotype 24F (n=492, 502, 506)
    81.1 (77.4 to 84.5)
    80.9 (77.2 to 84.2)
    79.6 (75.9 to 83.1)
    ( to )
        Serotype 31 (n=492, 502, 505)
    85.8 (82.4 to 88.7)
    84.3 (80.8 to 87.3)
    82.4 (78.8 to 85.6)
    ( to )
        Serotype 33F (n=494, 502, 505)
    73.5 (69.4 to 77.3)
    71.7 (67.6 to 75.6)
    73.7 (69.6 to 77.5)
    ( to )
        Serotype 35B (n=494, 502, 505)
    67.8 (63.5 to 71.9)
    66.7 (62.4 to 70.8)
    64.2 (59.8 to 68.3)
    ( to )
    Notes
    [243] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Secondary: GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots

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    End point title
    		 GMTs of serotype-specific OPA for cross-reactive serotypes following vaccination with separate V116 Lots
    End point description
    Serotype-specific OPA titers for cross-reactive serotypes (6A, 6C, 15B, and 15C) were determined using MOPA. The 95% CIs for serotype-specific OPA GMTs were calculated based on the t-distribution. Per protocol, the PPSV23 treatment group was not included as it was not analyzed with the individual lots of V116. Per protocol, all randomized participants who were vaccinated with V116 and were without deviations from the protocol that may substantially affect the results of the immunogenicity endpoint and who had sufficient data to perform the analysis were analyzed. Deviations include, but are not limited to the following: randomized but not vaccinated, blood drawn out of time window, prohibited concomitant medication or vaccination.
    End point type
    Secondary
    End point timeframe
    Day 30
    End point values
    		 V116 Lot 1 V116 Lot 2 V116 Lot 3 PPSV23
    Number of subjects analysed
    539
    538
    540
    0 [244]
    Units: Titers
    geometric mean (confidence interval 95%)
        Serotype 6A (n=428, 451, 442)
    6849.6 (6120.8 to 7665.0)
    6009.2 (5348.8 to 6751.0)
    6724.3 (5967.6 to 7577.0)
    ( to )
        Serotype 6C (n=434, 442, 438)
    3972.7 (3501.8 to 4506.9)
    3421.5 (3006.5 to 3893.8)
    3750.9 (3298.0 to 4265.9)
    ( to )
        Serotype 15B (n=416, 437, 417)
    11799.5 (10317.9 to 13493.8)
    10062.4 (8838.3 to 11456.1)
    11139.5 (9619.7 to 12899.4)
    ( to )
        Serotype 15C (n=429, 442, 422)
    13079.8 (11543.5 to 14820.6)
    11332.5 (9905.9 to 12964.7)
    11290.9 (9805.6 to 13001.2)
    ( to )
    Notes
    [244] - Per protocol, the PPSV23 treatment group was not analyzed with the separate V116 lots.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events were collected up to 30 days postvaccination. Serious adverse events and all-cause mortality were reported throughout the duration of the study, up to 194 days.
    Adverse event reporting additional description
    All-Cause Mortality included all randomized participants. The safety analysis population included all randomized participants who were vaccinated according to the vaccination they received. One participant in the V116 Lot 1 arm received V116 Lot 3, two participants randomized to the V116 Lot 2 arm received V116 Lot 1 and PPSV23, respectively.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    V116 Lot 1
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.

    Reporting group title
    PPSV23
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of PPSV23 on Day 1.

    Reporting group title
    V116 Lot 3
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 3 on Day 1.

    Reporting group title
    V116 Lot 2
    Reporting group description
    		 Participants received a single 0.5 mL IM dose of V116 Lot 2 on Day 1.

    Serious adverse events
    		 V116 Lot 1 PPSV23 V116 Lot 3 V116 Lot 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 539 (1.48%)
    6 / 541 (1.11%)
    1 / 541 (0.18%)
    5 / 536 (0.93%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    1
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Oligodendroglioma
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 539 (0.00%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    1 / 536 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 539 (0.00%)
    1 / 541 (0.18%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    0 / 539 (0.00%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    1 / 536 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal perforation
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major depression
         subjects affected / exposed
    0 / 539 (0.00%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    1 / 536 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 539 (0.00%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    1 / 536 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 539 (0.00%)
    0 / 541 (0.00%)
    1 / 541 (0.18%)
    1 / 536 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 539 (0.19%)
    0 / 541 (0.00%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 539 (0.00%)
    1 / 541 (0.18%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 539 (0.00%)
    1 / 541 (0.18%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 539 (0.00%)
    1 / 541 (0.18%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 539 (0.00%)
    1 / 541 (0.18%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
         subjects affected / exposed
    0 / 539 (0.00%)
    1 / 541 (0.18%)
    0 / 541 (0.00%)
    0 / 536 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V116 Lot 1 PPSV23 V116 Lot 3 V116 Lot 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    428 / 539 (79.41%)
    388 / 541 (71.72%)
    421 / 541 (77.82%)
    415 / 536 (77.43%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    165 / 539 (30.61%)
    131 / 541 (24.21%)
    154 / 541 (28.47%)
    154 / 536 (28.73%)
         occurrences all number
    172
    140
    163
    166
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    206 / 539 (38.22%)
    184 / 541 (34.01%)
    187 / 541 (34.57%)
    184 / 536 (34.33%)
         occurrences all number
    206
    186
    188
    186
    Injection site erythema
         subjects affected / exposed
    74 / 539 (13.73%)
    41 / 541 (7.58%)
    71 / 541 (13.12%)
    79 / 536 (14.74%)
         occurrences all number
    74
    41
    71
    80
    Injection site pain
         subjects affected / exposed
    393 / 539 (72.91%)
    328 / 541 (60.63%)
    400 / 541 (73.94%)
    391 / 536 (72.95%)
         occurrences all number
    394
    328
    401
    392
    Injection site swelling
         subjects affected / exposed
    68 / 539 (12.62%)
    41 / 541 (7.58%)
    64 / 541 (11.83%)
    82 / 536 (15.30%)
         occurrences all number
    68
    41
    64
    82
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    98 / 539 (18.18%)
    49 / 541 (9.06%)
    95 / 541 (17.56%)
    75 / 536 (13.99%)
         occurrences all number
    98
    49
    95
    75

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2022
    AM1: The purpose of the amendment was to update the Sponsor's entity name and address change.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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