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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults

    Summary
    EudraCT number
    		 2022-000258-27
    Trial protocol
    		 DE   SE   BE  
    Global end of trial date
    18 May 2023

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

    Trial information

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    Trial identification
    Sponsor protocol code
    V116-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05425732
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, Rahway, NJ, United States, P.O. Box 2000
    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
    18 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    18 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
    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
    13 Jul 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
    Australia: 95
    Country: Number of subjects enrolled
    Belgium: 155
    Country: Number of subjects enrolled
    Chile: 135
    Country: Number of subjects enrolled
    Germany: 80
    Country: Number of subjects enrolled
    New Zealand: 290
    Country: Number of subjects enrolled
    Puerto Rico: 155
    Country: Number of subjects enrolled
    Korea, Republic of: 200
    Country: Number of subjects enrolled
    Sweden: 110
    Country: Number of subjects enrolled
    Taiwan: 123
    Country: Number of subjects enrolled
    Türkiye: 56
    Country: Number of subjects enrolled
    United States: 1264
    Worldwide total number of subjects
    2663
    EEA total number of subjects
    345
    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)
    1480
    From 65 to 84 years
    1156
    85 years and over
    27

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Pneumococcal vaccine-naïve adults ≥18 years of age were enrolled in this study. Participants with underlying chronic conditions were eligible if the conditions were assessed to be stable per the investigator’s judgment.

    Period 1
    Period 1 title
    Started/Randommized
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 V116
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of V116 in a 0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.

    Arm title
    		 Cohort 1 PCV20
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV20
    Investigational medicinal product code
    Other name
    Prevnar 20™ APEXXNAR™
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of PCV20 in 0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.

    Arm title
    		 Cohort 2 V116
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of V116 in a 0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.

    Arm title
    		 Cohort 2 PCV20
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV20
    Investigational medicinal product code
    Other name
    Prevnar 20™ APEXXNAR™
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of PCV20 in 0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.

    Number of subjects in period 1
    		Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Started
    1181
    1181
    201
    100
    Safety All Cause Mortality (ACM)
    1179
    1179
    201
    100
    Completed
    1179
    1177
    200
    100
    Not completed
    2
    4
    1
    0
         Consent withdrawn by subject
    1
    1
    1
    -
         Physician decision
    -
    1
    -
    -
         Randomized By Mistake Without Study Treatment
    1
    2
    -
    -
    Period 2
    Period 2 title
    Vaccinated
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1 V116
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of V116 in a 0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.

    Arm title
    		 Cohort 1 PCV20
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV20
    Investigational medicinal product code
    Other name
    Prevnar 20™ APEXXNAR™
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of PCV20 in 0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.

    Arm title
    		 Cohort 2 V116
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of V116 in a 0.5 mL injection solution in prefilled syringe containing 4 μg of each PnPs antigen (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B) given by intramuscular (IM) injection.

    Arm title
    		 Cohort 2 PCV20
    Arm description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PCV20
    Investigational medicinal product code
    Other name
    Prevnar 20™ APEXXNAR™
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single dose of PCV20 in 0.5 mL injection suspension in prefilled syringe containing 2.2 μg of each PnPs antigen (1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, 33F) and 4.4 μg of PnPs antigen 6B.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Instead of Period 1, Period 2, vaccinated, was the baseline period.
    Number of subjects in period 2 [2]
    		Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Started
    1179
    1177
    200
    100
    All Participants as Treated (APaT)
    1177
    1175
    200
    100
    Safety Adverse Event (AE)
    1177
    1175
    200
    100
    Completed
    1160
    1152
    195
    96
    Not completed
    19
    25
    5
    4
         Adverse event, serious fatal
    4
    2
    -
    -
         Consent withdrawn by subject
    3
    7
    -
    1
         Physician decision
    -
    1
    -
    -
         Randomized to PCV20 then V116
    2
    -
    -
    -
         Lost to follow-up
    10
    15
    5
    3
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of participants in the baseline period was not the worldwide number enrolled, but rather the number vaccinated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1 V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.

    Reporting group title
    Cohort 1 PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.

    Reporting group title
    Cohort 2 V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.

    Reporting group title
    Cohort 2 PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.

    Reporting group values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20 Total
    Number of subjects
    		 1179 1177 200 100 2656
    Age Categorical
    Units: Participants
        18 to 49 years
    		 0 0 200 100 300
        50 to 64 years
    		 589 587 0 0 1176
        65 to 74 years
    		 464 464 0 0 928
        75 to 84 years
    		 112 113 0 0 225
        ≥85 years
    		 14 13 0 0 27
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 63.9 ( 8.3 ) 63.9 ( 8.3 ) 35.2 ( 9.0 ) 34.6 ( 8.7 ) -
    Sex: Female, Male
    Units:
        Female
    		 687 670 137 64 1558
        Male
    		 492 507 63 36 1098
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 4 4 0 1 9
        Asian
    		 148 168 38 15 369
        Native Hawaiian or Other Pacific Islander
    		 17 16 1 2 36
        Black or African American
    		 116 115 13 14 258
        White
    		 867 844 139 62 1912
        More than one race
    		 26 30 9 6 71
        Unknown or Not Reported
    		 1 0 0 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 259 242 58 24 583
        Not Hispanic or Latino
    		 909 922 141 76 2048
        Unknown or Not Reported
    		 11 13 1 0 25

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1 V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.

    Reporting group title
    Cohort 1 PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.

    Reporting group title
    Cohort 2 V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.

    Reporting group title
    Cohort 2 PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
    Reporting group title
    Cohort 1 V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 21-valent conjugate vaccine (V116) on Day 1.

    Reporting group title
    Cohort 1 PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of pneumococcal 20-valent conjugate vaccine (PCV20) on Day 1.

    Reporting group title
    Cohort 2 V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.

    Reporting group title
    Cohort 2 PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.

    Subject analysis set title
    V116 18 to 49 years old
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal vaccine-naïve adult participants 18 to 49 years of age receive a single dose of V116 on Day 1.

    Subject analysis set title
    V116 50 to 64 years old
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal vaccine-naïve adult participants 50 to 64 years of age receive a single dose of V116 on Day 1.

    Subject analysis set title
    V116 18 to 49 years old
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal vaccine-naïve adult participants in Cohort 2 (18 to 49 years of age) receive a single dose of V116 on Day 1.

    Subject analysis set title
    V116 50 to 64 years old
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Pneumococcal vaccine-naïve adult participants in Cohort 1 50 to 64 years of age receive a single dose of V116 on Day 1.

    Primary: Percentage of participants with solicited injection-site adverse events (AEs)

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    End point title
    		 Percentage of participants with solicited injection-site adverse events (AEs)
    End point description
    An AE is 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 consist of the following: pain/tenderness, redness/erythema, and swelling. The population analyzed was all participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
    End point type
    Primary
    End point timeframe
    Up to 5 days post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1177
    1175
    200
    100
    Units: Percentage of participants
    number (not applicable)
        Injection site erythema
    5.4
    6.3
    15.5
    13.0
        Injection site pain
    39.4
    51.7
    71.5
    74.0
        Injection site swelling
    6.0
    8.3
    14.0
    14.0
    Statistical analysis title
    		 Injection site erythema
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2352
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    -0.9
    Confidence interval
         level
    		 96%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 1.1
    Notes
    [1] - Miettinen & Nurminen method
    Statistical analysis title
    		 Injection site pain
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2352
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    -12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.2
         upper limit
    		 -8.2
    Notes
    [2] - Miettinen & Nurminen method
    Statistical analysis title
    		 Injection site swelling
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 2 V116 v Cohort 2 PCV20
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 7.9
    Notes
    [3] - Miettinen & Nurminen method
    Statistical analysis title
    		 Injection site erythema:
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 2 V116 v Cohort 2 PCV20
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 10.3
    Notes
    [4] - Miettinen & Nurminen method
    Statistical analysis title
    		 Injection site pain
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 2 V116 v Cohort 2 PCV20
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.7
         upper limit
    		 8.6
    Notes
    [5] - Miettinen & Nurminen method
    Statistical analysis title
    		 Injection site swelling
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2352
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    -2.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 -0.2
    Notes
    [6] - Miettinen & Nurminen method

    Primary: Percentage of participants with solicited systemic AEs

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    End point title
    		 Percentage of participants with solicited systemic AEs
    End point description
    An AE is 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 consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C). The population analyzed was all participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
    End point type
    Primary
    End point timeframe
    Up to 5 days post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1177
    1175
    200
    100
    Units: Percentage of participants
    number (not applicable)
        Fatigue
    20.1
    19.6
    40.5
    34.0
        Headache
    11.5
    12.9
    29.5
    24.0
        Myalgia
    5.9
    6.7
    16.5
    14.0
        Pyrexia
    1.3
    1.3
    3.5
    1.0
    Statistical analysis title
    		 Fatigue
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2352
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 3.8
    Notes
    [7] - Miettinen & Nurminen method
    Statistical analysis title
    		 Headache
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2352
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    -1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 1.2
    Notes
    [8] - Miettinen & Nurminen method
    Statistical analysis title
    		 Fatigue
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 2 V116 v Cohort 2 PCV20
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.3
         upper limit
    		 17.6
    Notes
    [9] - Miettinen & Nurminen method
    Statistical analysis title
    		 Headache
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 2 V116 v Cohort 2 PCV20
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.5
         upper limit
    		 15.5
    Notes
    [10] - Miettinen & Nurminen method
    Statistical analysis title
    		 Myalgia
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 2 V116 v Cohort 2 PCV20
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.8
         upper limit
    		 10.6
    Notes
    [11] - Miettinen & Nurminen method
    Statistical analysis title
    		 Pyrexia
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 2 V116 v Cohort 2 PCV20
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 6.2
    Notes
    [12] - Miettinen & Nurminen method
    Statistical analysis title
    		 Myalgia:
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2352
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 1.2
    Notes
    [13] - Miettinen & Nurminen method
    Statistical analysis title
    		 Pyrexia
    Statistical analysis description
    Estimated difference in percent
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2352
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    Method
    Parameter type
    		 Difference in Percent
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1
    Notes
    [14] - Miettinen & Nurminen method

    Primary: Percentage of participants with vaccine-related serious AE (SAE)

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    End point title
    		 Percentage of participants with vaccine-related serious AE (SAE) [15]
    End point description
    A vaccine-related SAE is any untoward medical consequence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event, which is determined by the investigator to be related to the vaccine. The population analyzed was all participants as treated consisting of randomized participants who were included in the group corresponding to the vaccine actually received.
    End point type
    Primary
    End point timeframe
    Up to 194 days post-vaccination
    Notes
    [15] - 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: No statistical comparison was specified because the results were zero.
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1177
    1175
    200
    100
    Units: Percentage of participants
        number (not applicable)
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Primary: Serotype specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohort 1 only, for the pneumococcal serotypes contained in V116 and PCV20

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    End point title
    		 Serotype specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohort 1 only, for the pneumococcal serotypes contained in V116 and PCV20
    End point description
    The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model.The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. 99999 means per protocol, within group CIs, or any other measures of dispersion, were not determined. The population analyzed was all randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.
    End point type
    Primary
    End point timeframe
    Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177
    0 [16]
    0 [17]
    Units: Titer
    geometric mean (confidence interval 95%)
        Serotype 3
    274.0 (0 to 99999)
    176.7 (0 to 99999)
    ( to )
    ( to )
        Serotype 6A
    2302.0 (0 to 99999)
    2972.5 (0 to 99999)
    ( to )
    ( to )
        Serotype 7F
    3637.4 (0 to 99999)
    3429.9 (0 to 99999)
    ( to )
    ( to )
        Serotype 8
    2501.3 (90 to 99999)
    1811.1 (0 to 99999)
    ( to )
    ( to )
        Serotype 10A
    3893.4 (0 to 99999)
    4678.0 (0 to 99999)
    ( to )
    ( to )
        Serotype 11A
    3232.6 (0 to 99999)
    2092.8 (0 to 99999)
    ( to )
    ( to )
        Serotype 12F
    2641.2 (0 to 99999)
    2499.6 (0 to 99999)
    ( to )
    ( to )
        Serotype 19A
    2136.1 (0 to 99999)
    2817.8 (0 to 99999)
    ( to )
    ( to )
        Serotype 22F
    3874.5 (0 to 99999)
    4770.1 (0 to 99999)
    ( to )
    ( to )
        Serotype 33F
    13558.9 (0 to 99999)
    11742.1 (0 to 99999)
    ( to )
    ( to )
        Serotype 9N
    7470.7 (0 to 99999)
    1640.4 (0 to 99999)
    ( to )
    ( to )
        Serotype 15A
    5237.2 (0 to 99999)
    1589.0 (0 to 99999)
    ( to )
    ( to )
        Serotype 15C
    4216.2 (0 to 99999)
    2072.3 (0 to 99999)
    ( to )
    ( to )
        Serotype 16F
    4868.2 (0 to 99999)
    846.3 (0 to 99999)
    ( to )
    ( to )
        Serotype 17F
    7764.9 (0 to 99999)
    460.4 (0 to 99999)
    ( to )
    ( to )
        Serotype 20A
    6099.2 (0 to 99999)
    631.1 (0 to 99999)
    ( to )
    ( to )
        Serotype 23A
    3737.2 (0 to 99999)
    461.5 (0 to 99999)
    ( to )
    ( to )
        Serotype 23B
    1082.5 (0 to 99999)
    107.3 (0 to 99999)
    ( to )
    ( to )
        Serotype 24F
    2728.6 (0 to 99999)
    70.5 (0 to 99999)
    ( to )
    ( to )
        Serotype 31
    3132.5 (0 to 99999)
    144.4 (0 to 99999)
    ( to )
    ( to )
        Serotype 35B
    8527.8 (0 to 99999)
    1383.0 (0 to 99999)
    ( to )
    ( to )
    Notes
    [16] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    [17] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [18]
    P-value
    		 < 0.001 [19]
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 1.72
    Notes
    [18] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    [19] - 1-sided
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [20]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.88
    Notes
    [20] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 9N
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [21]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    4.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.12
         upper limit
    		 5.04
    Notes
    [21] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [22]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.32
    Notes
    [22] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [23]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.92
    Notes
    [23] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [24]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.84
    Notes
    [24] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 12F
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [25]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.21
    Notes
    [25] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 11A
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [26]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 1.72
    Notes
    [26] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 10A
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [27]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.93
    Notes
    [27] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 8
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [28]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.53
    Notes
    [28] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 7
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [29]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.18
    Notes
    [29] - A conclusion of non-inferiority is based on the lower bound of the 95% CI for the estimated GMT Ratio (V116/PCV20) being > 0.5 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 31
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [30]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    21.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.68
         upper limit
    		 25.18
    Notes
    [30] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 24F
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [31]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    38.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.87
         upper limit
    		 44.25
    Notes
    [31] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 23B
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [32]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    10.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.48
         upper limit
    		 12
    Notes
    [32] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 23A
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [33]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    8.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.86
         upper limit
    		 9.55
    Notes
    [33] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 35B
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [34]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    6.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.59
         upper limit
    		 6.8
    Notes
    [34] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 17F
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [35]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    16.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.9
         upper limit
    		 19.09
    Notes
    [35] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 16F
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [36]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    5.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.16
         upper limit
    		 6.41
    Notes
    [36] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 15C
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [37]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    2.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.77
         upper limit
    		 2.34
    Notes
    [37] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 15A
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [38]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.91
         upper limit
    		 3.74
    Notes
    [38] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).
    Statistical analysis title
    		 Serotype 20A
    Statistical analysis description
    V116/PCV20 GMT Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [39]
    P-value
    		 < 0.001
    Method
    		 cLDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    9.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.66
         upper limit
    		 10.79
    Notes
    [39] - A conclusion of superiority is based on the lower bound of the 95% CI for the estimated GMT ratio (V116/PCV20) being > 2.0 (one-sided p-value < 0.025).

    Primary: Percentage of participants with ≥4-fold change from baseline in serotype specific OPA responses in Cohort 1 only for the 11 unique pneumococcal serotypes contained in V116.

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    End point title
    		 Percentage of participants with ≥4-fold change from baseline in serotype specific OPA responses in Cohort 1 only for the 11 unique pneumococcal serotypes contained in V116.
    End point description
    The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. 99999 means per protocol, within group CIs, or any other measures of dispersion, were not determined. The population analyzed was all randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window
    End point type
    Primary
    End point timeframe
    Baseline and Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177
    0 [40]
    0 [41]
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 9N
    64.7 (0 to 99999)
    19.9 (0 to 99999)
    ( to )
    ( to )
        Serotype 15A
    66.7 (0 to 99999)
    35.8 (0 to 99999)
    ( to )
    ( to )
        Serotype 15C
    83.4 (0 to 99999)
    74.2 (0 to 99999)
    ( to )
    ( to )
        Serotype 16F
    71.9 (0 to 99999)
    20.8 (0 to 99999)
    ( to )
    ( to )
        Serotype 17F
    75.8 (0 to 99999)
    9.5 (0 to 99999)
    ( to )
    ( to )
        Serotype 20A
    67.3 (0 to 99999)
    9.6 (0 to 99999)
    ( to )
    ( to )
        Serotype 23A
    78.9 (0 to 99999)
    36.8 (0 to 99999)
    ( to )
    ( to )
        Serotype 23B
    85.5 (0 to 99999)
    49.6 (0 to 99999)
    ( to )
    ( to )
        Serotype 24F
    80.5 (0 to 99999)
    6.3 (0 to 99999)
    ( to )
    ( to )
        Serotype 31
    76.5 (0 to 99999)
    17.9 (0 to 99999)
    ( to )
    ( to )
        Serotype 35B
    60.0 (0 to 99999)
    6.8 (0 to 99999)
    ( to )
    ( to )
    Notes
    [40] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    [41] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    Statistical analysis title
    		 Serotype 15A
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [42]
    P-value
    		 < 0.001 [43]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    30.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.8
         upper limit
    		 35.8
    Notes
    [42] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [43] - 1-sided
    Statistical analysis title
    		 Serotype 9N
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [44]
    P-value
    		 < 0.001 [45]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    44.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 40.7
         upper limit
    		 48.6
    Notes
    [44] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [45] - 1-sided
    Statistical analysis title
    		 Serotype 16F
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [46]
    P-value
    		 < 0.001 [47]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    51.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.1
         upper limit
    		 54.9
    Notes
    [46] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [47] - 1-sided
    Statistical analysis title
    		 Serotype 15C
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [48]
    P-value
    		 < 0.001 [49]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.6
         upper limit
    		 12.9
    Notes
    [48] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [49] - 1-sided
    Statistical analysis title
    		 Serotype24F
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [50]
    P-value
    		 < 0.001 [51]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    74.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 71.1
         upper limit
    		 77.1
    Notes
    [50] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [51] - 1-sided
    Statistical analysis title
    		 Serotype 31
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [52]
    P-value
    		 < 0.001 [53]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    58.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 54.8
         upper limit
    		 62.1
    Notes
    [52] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [53] - 1-sided
    Statistical analysis title
    		 Serotype 23B
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [54]
    P-value
    		 < 0.001 [55]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    35.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 32.1
         upper limit
    		 39.6
    Notes
    [54] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [55] - 1-sided
    Statistical analysis title
    		 Serotype 23A
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [56]
    P-value
    		 < 0.001 [57]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    42.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 37.6
         upper limit
    		 46.6
    Notes
    [56] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [57] - 1-sided
    Statistical analysis title
    		 Serotype35B
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [58]
    P-value
    		 < 0.001 [59]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    53.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49.6
         upper limit
    		 56.6
    Notes
    [58] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [59] - 1-sided
    Statistical analysis title
    		 Serotype 17F
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [60]
    P-value
    		 < 0.001 [61]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    66.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 62.8
         upper limit
    		 69.6
    Notes
    [60] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [61] - 1-sided
    Statistical analysis title
    		 Serotype 20A
    Statistical analysis description
    V116-PCV20 Percentage Difference
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [62]
    P-value
    		 < 0.001 [63]
    Method
    		 Stratified Miettinen & Nurminen
    Parameter type
    		 Percent Difference
    Point estimate
    57.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 54.2
         upper limit
    		 61.1
    Notes
    [62] - A conclusion of superiority is based on the lower bound of the 95% CI for the difference [V116 - PCV20] between the percentages of participants with a ≥4-fold rise from baseline being >10 percentage points (one-sided p-value < 0.025).
    [63] - 1-sided

    Primary: Serotype specific OPA GMTs in participants 18-49 years and participants 50-64 years for the pneumococcal serotypes contained in V116

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    End point title
    		 Serotype specific OPA GMTs in participants 18-49 years and participants 50-64 years for the pneumococcal serotypes contained in V116
    End point description
    The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. 99999 means per protocol, within group CIs, or any other measures of dispersion, were not determined. The population analyzed was all randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.
    End point type
    Primary
    End point timeframe
    Day 30 post-vaccination
    End point values
    		 V116 18 to 49 years old V116 50 to 64 years old
    Number of subjects analysed
    200
    589
    Units: Titer
    geometric mean (confidence interval 95%)
        Serotype 3
    308.6 (0 to 99999)
    282.7 (0 to 99999)
        Serotype 6A
    5289.6 (0 to 99999)
    2572.9 (0 to 99999)
        Serotype 7F
    6447.2 (0 to 99999)
    4278.8 (0 to 99999)
        Serotype 8
    4516.0 (0 to 99999)
    3004.7 (0 to 99999)
        Serotype 9N
    17283.2 (0 to 99999)
    8791.4 (0 to 99999)
        Serotype 10A
    6808.1 (0 to 99999)
    4382.6 (0 to 99999)
        Serotype 11A
    5871.6 (0 to 99999)
    3785.8 (0 to 99999)
        Serotype 12F
    6150.4 (0 to 99999)
    3561.2 (0 to 99999)
        Serotype 15A
    11319.2 (0 to 99999)
    5901.2 (0 to 99999)
        Serotype 15C
    10194.0 (0 to 99999)
    5708.0 (0 to 99999)
        Serotype 16F
    8877.0 (0 to 99999)
    5720.0 (0 to 99999)
        Serotype 17F
    16070.6 (0 to 99999)
    10068.0 (0 to 99999)
        Serotype 19A
    2773.2 (0 to 99999)
    2374.6 (0 to 99999)
        Serotype 20A
    13150.0 (0 to 99999)
    7562.7 (0 to 99999)
        Serotype 22F
    9299.6 (0 to 99999)
    4683.6 (0 to 99999)
        Serotype 23A
    8848.7 (0 to 99999)
    4739.5 (0 to 99999)
        Serotype 23B
    2140.1 (0 to 99999)
    1420.9 (0 to 99999)
        Serotype 24F
    4137.6 (0 to 99999)
    3047.2 (0 to 99999)
        Serotype 31
    8005.6 (0 to 99999)
    3820.7 (0 to 99999)
        Serotype 33F
    34805.5 (0 to 99999)
    17607.4 (0 to 99999)
        Serotype 35B
    13933.4 (0 to 99999)
    9053.9 (0 to 99999)
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [64]
    P-value
    		 < 0.001 [65]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.33
    Notes
    [64] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [65] - 1-sided
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [66]
    P-value
    		 < 0.001 [67]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    2.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.61
         upper limit
    		 2.62
    Notes
    [66] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [67] - 1-sided
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [68]
    P-value
    		 < 0.001 [69]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.51
    Confidence interval
         level
    		 5%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 1.84
    Notes
    [68] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [69] - 1-sided
    Statistical analysis title
    		 Serotype 8
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [70]
    P-value
    		 < 0.001 [71]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 1.79
    Notes
    [70] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [71] - 1-sided
    Statistical analysis title
    		 Serotype 15A
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [72]
    P-value
    		 < 0.001 [73]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.55
         upper limit
    		 2.37
    Notes
    [72] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [73] - 1-sided
    Statistical analysis title
    		 Serotype 10A
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [74]
    P-value
    		 < 0.001 [75]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 1.92
    Notes
    [74] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [75] - 1-sided
    Statistical analysis title
    		 Serotype 11A
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [76]
    P-value
    		 < 0.001 [77]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 1.91
    Notes
    [76] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [77] - 1-sided
    Statistical analysis title
    		 Serotype 12F
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [78]
    P-value
    		 < 0.001 [79]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 2.17
    Notes
    [78] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [79] - 1-sided
    Statistical analysis title
    		 Serotype 9N
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [80]
    P-value
    		 < 0.001 [81]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.59
         upper limit
    		 2.43
    Notes
    [80] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [81] - 1-sided
    Statistical analysis title
    		 Serotype 15C
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [82]
    P-value
    		 < 0.001 [83]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.36
         upper limit
    		 2.35
    Notes
    [82] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [83] - 1-sided
    Statistical analysis title
    		 Serotype 16F
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [84]
    P-value
    		 < 0.001 [85]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 1.91
    Notes
    [84] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [85] - 1-sided
    Statistical analysis title
    		 Serotype 17F
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [86]
    P-value
    		 < 0.001 [87]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 2.02
    Notes
    [86] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [87] - 1-sided
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [88]
    P-value
    		 < 0.001 [89]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.4
    Notes
    [88] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [89] - 1-sided
    Statistical analysis title
    		 Serotype 20A
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [90]
    P-value
    		 < 0.001 [91]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 2.18
    Notes
    [90] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [91] - 1-sided
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [92]
    P-value
    		 < 0.001 [93]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.58
         upper limit
    		 2.49
    Notes
    [92] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [93] - 1-sided
    Statistical analysis title
    		 Serotype 23A
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [94]
    P-value
    		 < 0.001 [95]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.43
         upper limit
    		 2.44
    Notes
    [94] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [95] - 1-sided
    Statistical analysis title
    		 Serotype 23B
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [96]
    P-value
    		 < 0.001 [97]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 2.04
    Notes
    [96] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [97] - 1-sided
    Statistical analysis title
    		 Serotype 24F
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [98]
    P-value
    		 < 0.001 [99]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.67
    Notes
    [98] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [99] - 1-sided
    Statistical analysis title
    		 Serotype 31
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [100]
    P-value
    		 < 0.001 [101]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.63
         upper limit
    		 2.69
    Notes
    [100] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [101] - 1-sided
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [102]
    P-value
    		 < 0.001 [103]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.52
         upper limit
    		 2.57
    Notes
    [102] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [103] - 1-sided
    Statistical analysis title
    		 Serotype 35B
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [104]
    P-value
    		 < 0.001 [105]
    Method
    		 LDA model
    Parameter type
    		 GMT Ratio
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 1.87
    Notes
    [104] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [105] - 1-sided

    Secondary: Percentage of participants from Cohort 1 V116 with ≥4-fold change in OPA responses for cross reactive pneumococcal serotypes

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    End point title
    		 Percentage of participants from Cohort 1 V116 with ≥4-fold change in OPA responses for cross reactive pneumococcal serotypes
    End point description
    The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being > 50 percentage points (one-sided p-value < 0.025). The population analyzed was all randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window. Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure. For arm PCV20: Cohort 1 99999 means per protocol, within group CIs, or any other measures of dispersion, were not determined.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177 [106]
    0 [107]
    0 [108]
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 6C
    49.3 (46.0 to 52.6)
    0 (0 to 99999)
    ( to )
    ( to )
        Serotype 15B
    64.7 (61.4 to 67.8)
    0 (0 to 99999)
    ( to )
    ( to )
    Notes
    [106] - Per protocol, Cohort 1: PCV20 were not analyzed in this endpoint.
    [107] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    [108] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    Statistical analysis title
    		 Serotype 15B
    Statistical analysis description
    Serotype 15B
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [109]
    P-value
    		 < 0.001 [110]
    Method
    		 Clopper-Pearson method.
    Confidence interval
    Notes
    [109] - A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being > 50 percentage points (one-sided p-value < 0.025).
    [110] - 1-sided
    Statistical analysis title
    		 Serotype 6C
    Statistical analysis description
    Serotype 6C
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [111]
    P-value
    		 = 0.667 [112]
    Method
    		 Clopper-Pearson method.
    Confidence interval
    Notes
    [111] - A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline to 30 days postvaccination being > 50 percentage points (one-sided p-value < 0.025).
    [112] - 1-sided

    Secondary: Serotype specific OPA GMTs for cross reactive pneumococcal serotypes in adults 50 to 64 years of age from Cohort 1 and adults 18 to 49 years of age from Cohort 2

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    End point title
    		 Serotype specific OPA GMTs for cross reactive pneumococcal serotypes in adults 50 to 64 years of age from Cohort 1 and adults 18 to 49 years of age from Cohort 2
    End point description
    The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. 99999 means per protocol, within group CIs, or any other measures of dispersion, were not determined. The population analyzed was all randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.
    End point type
    Secondary
    End point timeframe
    Day 30 post-vaccination
    End point values
    		 V116 18 to 49 years old V116 50 to 64 years old
    Number of subjects analysed
    200
    589
    Units: Titer
    geometric mean (confidence interval 95%)
        6C
    2577.2 (0 to 99999)
    1254.7 (0 to 99999)
        15B
    10976.7 (0 to 99999)
    5438.9 (0 to 99999)
    Statistical analysis title
    		 Serotype 15B
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [113]
    P-value
    		 < 0.001 [114]
    Method
    		 LDA model
    Parameter type
    		 GMT
    Point estimate
    2.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.57
         upper limit
    		 2.6
    Notes
    [113] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).
    [114] - 1-sided
    Statistical analysis title
    		 Serotype 6C
    Statistical analysis description
    V116 18-49 years/V116 50-64 years GMT Ratio
    Comparison groups
    V116 18 to 49 years old v V116 50 to 64 years old
    Number of subjects included in analysis
    789
    Analysis specification
    Pre-specified
    Analysis type
    		 [115]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    2.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.52
         upper limit
    		 2.77
    Notes
    [115] - A conclusion of immunobridging is based on the lower bound of the 95% CI for the estimated GMT ratio (V116 18-49 Years/V116 50-64 Years) being > 0.5 (one-sided p-value < 0.025).

    Secondary: Serotype specific Immunoglobulin (IgG) geometric mean concentrations (GMCs) in Cohort 1 only, for the pneumococcal serotypes contained in V116 and PCV20

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    End point title
    		 Serotype specific Immunoglobulin (IgG) geometric mean concentrations (GMCs) in Cohort 1 only, for the pneumococcal serotypes contained in V116 and PCV20
    End point description
    The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. 99999 means per protocol, within group CIs, or any other measures of dispersion, were not determined. The population analyzed was all randomized participants from cohort 1 only, without deviations from the protocol that may substantially affect immunogenicity. Deviations include, but are not limited to the following: missing serology results; and blood draw out of window.
    End point type
    Secondary
    End point timeframe
    Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177
    0 [116]
    0 [117]
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 3
    0.78 (0 to 99999)
    0.53 (0 to 99999)
    ( to )
    ( to )
        Serotype 6A
    4.30 (0 to 99999)
    5.45 (0 to 99999)
    ( to )
    ( to )
        Serotype 7F
    6.97 (0 to 99999)
    6.57 (0 to 99999)
    ( to )
    ( to )
        Serotype 8
    10.02 (0 to 99999)
    7.00 (0 to 99999)
    ( to )
    ( to )
        Serotype 10A
    11.98 (0 to 99999)
    14.66 (0 to 99999)
    ( to )
    ( to )
        Serotype 11A
    7.20 (0 to 99999)
    5.87 (0 to 99999)
    ( to )
    ( to )
        Serotype 12F
    1.73 (0 to 99999)
    1.57 (0 to 99999)
    ( to )
    ( to )
        Serotype 19A
    8.39 (0 to 99999)
    12.02 (0 to 99999)
    ( to )
    ( to )
        Serotype 22F
    4.39 (0 to 99999)
    5.48 (0 to 99999)
    ( to )
    ( to )
        Serotype 33F
    13.81 (0 to 99999)
    13.02 (0 to 99999)
    ( to )
    ( to )
        Serotype 9N
    7.72 (0 to 99999)
    1.43 (0 to 99999)
    ( to )
    ( to )
        Serotype15A
    13.88 (0 to 99999)
    2.04 (0 to 99999)
    ( to )
    ( to )
        Serotype 15C
    12.39 (0 to 99999)
    5.04 (0 to 99999)
    ( to )
    ( to )
        Serotype 16F
    2.86 (0 to 99999)
    0.33 (0 to 99999)
    ( to )
    ( to )
        Serotype 17F
    14.16 (0 to 99999)
    0.84 (0 to 99999)
    ( to )
    ( to )
        Serotype 20A
    19.03 (0 to 99999)
    1.47 (0 to 99999)
    ( to )
    ( to )
        Serotype 23A
    3.78 (0 to 99999)
    0.59 (0 to 99999)
    ( to )
    ( to )
        Serotype 23B
    5.13 (0 to 99999)
    1.58 (0 to 99999)
    ( to )
    ( to )
        Serotype 24F
    6.87 (0 to 99999)
    0.33 (0 to 99999)
    ( to )
    ( to )
        Serotype 31
    3.07 (0 to 99999)
    0.27 (0 to 99999)
    ( to )
    ( to )
        Serotype 35B
    19.98 (0 to 99999)
    1.41 (0 to 99999)
    ( to )
    ( to )
    Notes
    [116] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    [117] - Per protocol, Cohort 2 were not analyzed in this endpoint.
    Statistical analysis title
    		 Serotype 7F
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [118]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.18
    Notes
    [118] - cLDA model
    Statistical analysis title
    		 Serotype 6A
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [119]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.89
    Notes
    [119] - cLDA model
    Statistical analysis title
    		 Serotype 3
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [120]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.35
         upper limit
    		 1.6
    Notes
    [120] - cLDA model
    Statistical analysis title
    		 Serotype 8
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [121]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 1.59
    Notes
    [121] - cLDA model
    Statistical analysis title
    		 Serotype 10A
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [122]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.92
    Notes
    [122] - cLDA model
    Statistical analysis title
    		 Serotype 11A
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [123]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.36
    Notes
    [123] - cLDA model
    Statistical analysis title
    		 Serotype 12F
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [124]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.26
    Notes
    [124] - cLDA model
    Statistical analysis title
    		 Serotype 33F
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [125]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.18
    Notes
    [125] - cLDA model
    Statistical analysis title
    		 Serotype 22F
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [126]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.9
    Notes
    [126] - cLDA model
    Statistical analysis title
    		 Serotype 19A
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [127]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.77
    Notes
    [127] - cLDA model
    Statistical analysis title
    		 Serotype 9N
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [128]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    5.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.82
         upper limit
    		 6.06
    Notes
    [128] - cLDA model
    Statistical analysis title
    		 Serotype 15A
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [129]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    6.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.03
         upper limit
    		 7.64
    Notes
    [129] - cLDA model
    Statistical analysis title
    		 Serotype 15C
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [130]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    2.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.17
         upper limit
    		 2.79
    Notes
    [130] - cLDA model
    Statistical analysis title
    		 Serotype 16F
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [131]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    8.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.95
         upper limit
    		 9.64
    Notes
    [131] - cLDA model
    Statistical analysis title
    		 Serotype 17F
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [132]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    16.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.25
         upper limit
    		 18.41
    Notes
    [132] - cLDA model
    Statistical analysis title
    		 Serotype 20A
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [133]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    12.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.81
         upper limit
    		 14.13
    Notes
    [133] - cLDA model
    Statistical analysis title
    		 Serotype 23A
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [134]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    6.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.69
         upper limit
    		 7.24
    Notes
    [134] - cLDA model
    Statistical analysis title
    		 Serotype 23B
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [135]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    3.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.91
         upper limit
    		 3.64
    Notes
    [135] - cLDA model
    Statistical analysis title
    		 Serotype 24F
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [136]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    21.08
    Confidence interval
         level
    		 85%
         sides
    2-sided
         lower limit
    		 18.97
         upper limit
    		 23.43
    Notes
    [136] - cLDA model
    Statistical analysis title
    		 Serotype 31
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [137]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    11.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.36
         upper limit
    		 12.34
    Notes
    [137] - cLDA model
    Statistical analysis title
    		 Serotype 35B
    Statistical analysis description
    V116/PCV20 GMC Ratio
    Comparison groups
    Cohort 1 V116 v Cohort 1 PCV20
    Number of subjects included in analysis
    2356
    Analysis specification
    Pre-specified
    Analysis type
    		 [138]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    14.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.97
         upper limit
    		 15.4
    Notes
    [138] - cLDA model

    Secondary: Geometric mean fold change from baseline in OPA GMTs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20

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    End point title
    		 Geometric mean fold change from baseline in OPA GMTs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20
    End point description
    The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177
    0 [139]
    0 [140]
    Units: GMFR
    geometric mean (confidence interval 95%)
        Serotype 3
    8.4 (7.7 to 9.1)
    5.4 (5.0 to 5.8)
    ( to )
    ( to )
        Serotype 6A
    18.1 (16.2 to 20.2)
    22.6 (20.1 to 25.5)
    ( to )
    ( to )
        Serotype 7F
    16.5 (14.4 to 18.8)
    14.7 (12.9 to 16.8)
    ( to )
    ( to )
        Serotype 8
    22.0 (19.3 to 25.0)
    14.2 (12.5 to 16.2)
    ( to )
    ( to )
        Serotype 10A
    16.7 (14.8 to 18.9)
    20.8 (18.3 to 23.8)
    ( to )
    ( to )
        Serotype11A
    17.4 (15.1 to 20.0)
    11.6 (10.1 to 13.3)
    ( to )
    ( to )
        Serotype 12F
    77.4 (68.5 to 87.4)
    73.5 (64.8 to 83.4)
    ( to )
    ( to )
        Serotype 19A
    8.6 (7.7 to 9.5)
    11.0 (9.9 to 12.2)
    ( to )
    ( to )
        Serotype 22F
    19.1 (16.6 to 22.1)
    25.5 (21.9 to 29.8)
    ( to )
    ( to )
        Serotype 33F
    9.9 (8.9 to 11.1)
    8.5 (7.6 to 9.5)
    ( to )
    ( to )
        Serotype 9N
    8.9 (8.0 to 9.9)
    2.0 (1.9 to 2.2)
    ( to )
    ( to )
        Serotype 15A
    9.4 (8.2 to 10.8)
    3.1 (2.7 to 3.5)
    ( to )
    ( to )
        Serotype 15C
    38.0 (33.3 to 43.3)
    20.3 (17.8 to 23.1)
    ( to )
    ( to )
        Serotype 16F
    9.5 (8.7 to 10.4)
    1.9 (1.7 to 2.0)
    ( to )
    ( to )
        Serotype 17F
    17.3 (15.3 to 19.7)
    1.2 (1.1 to 1.3)
    ( to )
    ( to )
        Serotype 20A
    10.3 (9.2 to 11.4)
    1.2 (1.1 to 1.2)
    ( to )
    ( to )
        Serotype 23A
    21.8 (19.0 to 25.0)
    3.1 (2.7 to 3.6)
    ( to )
    ( to )
        Serotype 23B
    51.4 (45.3 to 58.2)
    6.1 (5.4 to 6.9)
    ( to )
    ( to )
        Serotype 24F
    29.0 (25.6 to 32.8)
    1.1 (1.0 to 1.1)
    ( to )
    ( to )
        Serotype 31
    28.7 (24.9 to 33.1)
    1.5 (1.4 to 1.7)
    ( to )
    ( to )
        Serotype 35B
    7.2 (6.5 to 7.9)
    1.2 (1.1 to 1.2)
    ( to )
    ( to )
    Notes
    [139] - Per protocol Cohort 2 was not analyzed for this endpoint.
    [140] - Per protocol Cohort 2 was not analyzed for this endpoint.
    No statistical analyses for this end point

    Secondary: Geometric mean fold change from baseline in IgG antibody GMCs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20

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    End point title
    		 Geometric mean fold change from baseline in IgG antibody GMCs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20
    End point description
    The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177
    0 [141]
    0 [142]
    Units: GMFR
    geometric mean (confidence interval 95%)
        Serotype 3
    5.1 (4.8 to 5.4)
    3.5 (3.3 to 3.7)
    ( to )
    ( to )
        Serotype 6A
    12.2 (11.1 to 13.5)
    15.1 (13.8 to 16.6)
    ( to )
    ( to )
        Serotype 7F
    12.5 (11.5 to 13.7)
    12.2 (11.2 to 13.4)
    ( to )
    ( to )
        Serotype 8
    12.6 (11.5 to 13.8)
    8.8 (8.0 to 9.6)
    ( to )
    ( to )
        Serotype 10A
    15.4 (14.1 to 16.9)
    19.2 (17.4 to 21.1)
    ( to )
    ( to )
        Serotype 11A
    8.7 (8.1 to 9.5)
    7.1 (6.5 to 7.7)
    ( to )
    ( to )
        Serotype 12F
    13.1 (11.8 to 14.4)
    12.1 (11.0 to 13.5)
    ( to )
    ( to )
        Serotype 19A
    5.4 (5.0 to 5.8)
    7.7 (7.1 to 8.4)
    ( to )
    ( to )
        Serotype 22F
    12.7 (11.6 to 13.9)
    16.3 (14.8 to 17.9)
    ( to )
    ( to )
        Serotype 33F
    9.6 (8.8 to 10.5)
    9.1 (8.3 to 9.9)
    ( to )
    ( to )
        Serotype 9N
    15.0 (13.6 to 16.5)
    2.7 (2.5 to 2.9)
    ( to )
    ( to )
        Serotype 15A
    22.3 (20.3 to 24.4)
    3.4 (3.1 to 3.7)
    ( to )
    ( to )
        Serotype 15C
    19.8 (17.9 to 21.8)
    8.2 (7.4 to 9.0)
    ( to )
    ( to )
        Serotype 16F
    13.3 (12.3 to 14.4)
    1.6 (1.5 to 1.7)
    ( to )
    ( to )
        Serotype 17F
    19.8 (18.0 to 21.7)
    1.2 (1.1 to 1.3)
    ( to )
    ( to )
        Serotype 20A
    11.7 (10.8 to 12.8)
    0.9 (0.9 to 1.0)
    ( to )
    ( to )
        Serotype 23A
    17.8 (16.3 to 19.5)
    2.9 (2.6 to 3.1)
    ( to )
    ( to )
        Serotype 23B
    12.1 (11.1 to 13.3)
    3.8 (3.5 to 4.1)
    ( to )
    ( to )
        Serotype 24F
    21.2 (19.3 to 23.4)
    1.1 (1.0 to 1.1)
    ( to )
    ( to )
        Serotype 31
    13.0 (12.0 to 14.0)
    1.2 (1.2 to 1.3)
    ( to )
    ( to )
        Serotype 35B
    14.7 (13.6 to 16.0)
    1.0 (1.0 to 1.1)
    ( to )
    ( to )
    Notes
    [141] - Per protocol Cohort 2 was not analyzed for this endpoint.
    [142] - Per protocol Cohort 2 was not analyzed for this endpoint.
    No statistical analyses for this end point

    Secondary: Percentage of participants with ≥4-fold change from baseline in IgG antibody GMCs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20

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    End point title
    		 Percentage of participants with ≥4-fold change from baseline in IgG antibody GMCs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20
    End point description
    Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177
    0 [143]
    0 [144]
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 3
    56.5 (53.5 to 59.4)
    41.0 (38.0 to 44.0)
    ( to )
    ( to )
        Serotype 6A
    73.1 (70.4 to 75.7)
    79.7 (77.2 to 82.1)
    ( to )
    ( to )
        Serotype 7F
    76.4 (73.8 to 78.9)
    75.8 (73.2 to 78.4)
    ( to )
    ( to )
        Serotype 8
    75.8 (73.1 to 78.3)
    67.8 (64.9 to 70.6)
    ( to )
    ( to )
        Serotype 10A
    80.3 (77.8 to 82.6)
    82.0 (79.5 to 84.2)
    ( to )
    ( to )
        Serotype 11A
    71.1 (68.4 to 73.8)
    62.7 (59.8 to 65.6)
    ( to )
    ( to )
        Serotype 12F
    74.2 (71.5 to 76.7)
    71.4 (68.6 to 74.1)
    ( to )
    ( to )
        Serotype 19A
    55.6 (52.6 to 58.5)
    65.0 (62.0 to 67.8)
    ( to )
    ( to )
        Serotype 22F
    76.8 (74.2 to 79.3)
    78.5 (76.0 to 81.0)
    ( to )
    ( to )
        Serotype 33F
    71.6 (68.8 to 74.2)
    66.7 (63.8 to 69.6)
    ( to )
    ( to )
        Serotype 9N
    77.9 (75.3 to 80.3)
    29.4 (26.7 to 32.2)
    ( to )
    ( to )
        Serotype 15A
    85.7 (83.5 to 87.8)
    37.7 (34.8 to 40.7)
    ( to )
    ( to )
        Serotype 15C
    81.4 (78.9 to 83.6)
    63.2 (60.2 to 66.1)
    ( to )
    ( to )
        Serotype 16F
    81.4 (78.9 to 83.6)
    11.8 (10.0 to 13.9)
    ( to )
    ( to )
        Serotype 17F
    84.5 (82.2 to 86.6)
    4.3 (3.1 to 5.7)
    ( to )
    ( to )
        Serotype 20A
    74.7 (72.1 to 77.3)
    1.3 (0.7 to 2.2)
    ( to )
    ( to )
        Serotype 23A
    85.5 (83.3 to 87.6)
    29.4 (26.7 to 32.2)
    ( to )
    ( to )
        Serotype 23B
    76.1 (73.4 to 78.6)
    42.2 (39.3 to 45.2)
    ( to )
    ( to )
        Serotype 24F
    84.0 (81.7 to 86.1)
    2.3 (1.5 to 3.4)
    ( to )
    ( to )
        Serotype 31
    81.1 (78.6 to 83.4)
    3.9 (2.8 to 5.2)
    ( to )
    ( to )
        Serotype 35B
    83.1 (80.8 to 85.3)
    3.3 (2.3 to 4.5)
    ( to )
    ( to )
    Notes
    [143] - Per protocol Cohort 2 was not analyzed for this endpoint.
    [144] - Per protocol Cohort 2 was not analyzed for this endpoint.
    No statistical analyses for this end point

    Secondary: Percentage of participants with ≥4-fold change from baseline in OPA GMTs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20

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    End point title
    		 Percentage of participants with ≥4-fold change from baseline in OPA GMTs in Cohort 1 for the pneumococcal serotypes contained in V116 and PCV20
    End point description
    Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 30 post-vaccination
    End point values
    		 Cohort 1 V116 Cohort 1 PCV20 Cohort 2 V116 Cohort 2 PCV20
    Number of subjects analysed
    1179
    1177
    0 [145]
    0 [146]
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 3
    71.3 (68.4 to 74.2)
    59.1 (55.9 to 62.3)
    ( to )
    ( to )
        Serotype 6A
    76.8 (74.0 to 79.5)
    79.9 (77.2 to 82.4)
    ( to )
    ( to )
        Serotype 7F
    71.0 (68.1 to 73.9)
    65.9 (62.8 to 68.9)
    ( to )
    ( to )
        Serotype 8
    75.8 (73.0 to 78.4)
    67.4 (64.3 to 70.3)
    ( to )
    ( to )
        Serotype 10A
    71.9 (69.0 to 74.6)
    74.1 (71.3 to 76.9)
    ( to )
    ( to )
        Serotype11A
    70.0 (66.9 to 73.0)
    61.5 (58.2 to 64.7)
    ( to )
    ( to )
        Serotype 12F
    89.0 (87.0 to 90.9)
    87.1 (84.9 to 89.1)
    ( to )
    ( to )
        Serotype 19A
    64.4 (61.3 to 67.3)
    70.2 (67.2 to 73.0)
    ( to )
    ( to )
        Serotype 22F
    70.5 (67.5 to 73.4)
    74.4 (71.5 to 77.2)
    ( to )
    ( to )
        Serotype 33F
    67.7 (64.6 to 70.7)
    61.5 (58.3 to 64.6)
    ( to )
    ( to )
        Serotype 9N
    64.7 (61.5 to 67.8)
    19.9 (17.5 to 22.6)
    ( to )
    ( to )
        Serotype 15A
    66.7 (63.0 to 70.2)
    35.8 (32.3 to 39.5)
    ( to )
    ( to )
        Serotype 15C
    83.4 (80.9 to 85.7)
    74.2 (71.2 to 76.9)
    ( to )
    ( to )
        Serotype 16F
    71.9 (68.8 to 74.8)
    20.8 (18.3 to 23.5)
    ( to )
    ( to )
        Serotype 17F
    75.8 (72.7 to 78.6)
    9.5 (7.7 to 11.5)
    ( to )
    ( to )
        Serotype 20A
    67.3 (64.3 to 70.2)
    9.6 (7.8 to 11.6)
    ( to )
    ( to )
        Serotype 23A
    78.9 (75.8 to 81.7)
    36.8 (33.3 to 40.4)
    ( to )
    ( to )
        Serotype 23B
    85.5 (83.2 to 87.6)
    49.6 (46.4 to 52.7)
    ( to )
    ( to )
        Serotype 24F
    80.5 (77.8 to 83.0)
    6.3 (4.8 to 8.1)
    ( to )
    ( to )
        Serotype 31
    76.5 (73.6 to 79.3)
    17.9 (15.5 to 20.5)
    ( to )
    ( to )
        Serotype 35B
    60.0 (56.7 to 63.2)
    6.8 (5.3 to 8.5)
    ( to )
    ( to )
    Notes
    [145] - Per protocol Cohort 2 was not analyzed for this endpoint.
    [146] - Per protocol Cohort 2 was not analyzed for this endpoint.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality (ACM): Randomization up to 194 days post-vaccination. Serous adverse events (SAEs): Treatment (Day 1) up to 194 days post-vaccination. Non-serious AEs (NSAEs): Treatment (Day 1) up to 30 days post-vaccination.
    Adverse event reporting additional description
    ACM for Cohorts 1 and 2: randomized participants. ACM for Unplanned arm: participants randomized to both V116 and PCV20. The SAE and NSAE for Cohorts 1 and 2 was the APaT. The SAEs and NSAEs for the Unplanned arm: participants excluded from the APaT. ACMs or AEs for the Unplanned arm were reported as zero due to the risk of identification..
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Cohort 1: V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1.

    Reporting group title
    Cohort 1: PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1.

    Reporting group title
    Unplanned Participants
    Reporting group description
    		 Participants with unplanned randomization and unplanned treatment with both V116 and PCV20.

    Reporting group title
    Cohort 2: PCV20
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.

    Reporting group title
    Cohort 2: V116
    Reporting group description
    		 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1.

    Serious adverse events
    		 Cohort 1: V116 Cohort 1: PCV20 Unplanned Participants Cohort 2: PCV20 Cohort 2: V116
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 1177 (1.61%)
    24 / 1175 (2.04%)
    0 / 2 (0.00%)
    3 / 100 (3.00%)
    1 / 200 (0.50%)
         number of deaths (all causes)
    4
    2
    0
    0
    0
         number of deaths resulting from adverse events
    4
    2
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device occlusion
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Brain contusion
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 1177 (0.00%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    1 / 100 (1.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 1177 (0.08%)
    4 / 1175 (0.34%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery embolism
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 1177 (0.08%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 1177 (0.17%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radial nerve palsy
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral mucosa erosion
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jejunal perforation
         subjects affected / exposed
    0 / 1177 (0.00%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    1 / 100 (1.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Subcapsular hepatic haematoma
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic necrosis
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 1177 (0.08%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 1177 (0.00%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    1 / 100 (1.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    0 / 1177 (0.00%)
    1 / 1175 (0.09%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 1177 (0.17%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 1177 (0.00%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    1 / 200 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 1177 (0.08%)
    0 / 1175 (0.00%)
    0 / 2 (0.00%)
    0 / 100 (0.00%)
    0 / 200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: V116 Cohort 1: PCV20 Unplanned Participants Cohort 2: PCV20 Cohort 2: V116
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    615 / 1177 (52.25%)
    722 / 1175 (61.45%)
    0 / 2 (0.00%)
    78 / 100 (78.00%)
    161 / 200 (80.50%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    162 / 1177 (13.76%)
    174 / 1175 (14.81%)
    0 / 2 (0.00%)
    26 / 100 (26.00%)
    59 / 200 (29.50%)
         occurrences all number
    176
    184
    0
    29
    62
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    240 / 1177 (20.39%)
    235 / 1175 (20.00%)
    0 / 2 (0.00%)
    34 / 100 (34.00%)
    81 / 200 (40.50%)
         occurrences all number
    243
    237
    0
    34
    81
    Injection site erythema
         subjects affected / exposed
    82 / 1177 (6.97%)
    86 / 1175 (7.32%)
    0 / 2 (0.00%)
    13 / 100 (13.00%)
    32 / 200 (16.00%)
         occurrences all number
    83
    87
    0
    13
    32
    Injection site pain
         subjects affected / exposed
    471 / 1177 (40.02%)
    608 / 1175 (51.74%)
    0 / 2 (0.00%)
    74 / 100 (74.00%)
    143 / 200 (71.50%)
         occurrences all number
    474
    615
    0
    74
    143
    Injection site swelling
         subjects affected / exposed
    79 / 1177 (6.71%)
    103 / 1175 (8.77%)
    0 / 2 (0.00%)
    14 / 100 (14.00%)
    28 / 200 (14.00%)
         occurrences all number
    79
    105
    0
    14
    28
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    75 / 1177 (6.37%)
    82 / 1175 (6.98%)
    0 / 2 (0.00%)
    14 / 100 (14.00%)
    33 / 200 (16.50%)
         occurrences all number
    75
    83
    0
    14
    33

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 May 2023
    Amendment 2: Revised the superiority success criterion for serotype 15C.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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