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    Clinical Trial Results:
    A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older

    Summary
    EudraCT number
    		 2021-006679-41
    Trial protocol
    		 IT   ES   FR  
    Global end of trial date
    16 May 2023

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V116-006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05420961
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NC, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    16 May 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    16 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 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
    Canada: 75
    Country: Number of subjects enrolled
    Spain: 51
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Israel: 99
    Country: Number of subjects enrolled
    Italy: 33
    Country: Number of subjects enrolled
    Japan: 63
    Country: Number of subjects enrolled
    Korea, Republic of: 100
    Country: Number of subjects enrolled
    Taiwan: 67
    Country: Number of subjects enrolled
    United States: 225
    Worldwide total number of subjects
    717
    EEA total number of subjects
    88
    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)
    210
    From 65 to 84 years
    495
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 717 adults were randomized to 1 of 3 cohorts. The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study vaccination.

    Pre-assignment
    Screening details
    		 1 participant randomized to PCV15 in Cohort 1 incorrectly received V116; per protocol participant was included in Cohort 1 V116. 1 participant randomized to PCV15 in Cohort 1 received PPSV23 (intervention for Cohort 2); per protocol participant was excluded from APaT population, since intervention received was not 1 of the 2 designated in Cohort 1.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Cohorts 1 and 2 were double-blind. Cohort 3 was unblinded, open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: V116
    Arm description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.
    Arm type
    		 Experimental

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

    Arm title
    		 Cohort 1: PCV15
    Arm description
    		 Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PCV15
    Investigational medicinal product code
    Other name
    VAXNEUVANCE™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension

    Arm title
    		 Cohort 2: V116
    Arm description
    		 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.
    Arm type
    		 Experimental

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

    Arm title
    		 Cohort 2: PPSV23
    Arm description
    		 Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
    Arm type
    		 Active comparator

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

    Arm title
    		 Cohort 3: V116
    Arm description
    		 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
    Arm type
    		 Experimental

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

    Number of subjects in period 1
    		Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Started
    231
    119
    176
    85
    106
    Day 1 - Vaccinated with V116
    229
    1 [1]
    174
    0 [2]
    105
    Day 1 - Vaccinated with PCV15
    0 [3]
    117 [4]
    0 [5]
    0 [6]
    0 [7]
    Day 1 - Vaccinated with PPSV23
    0 [8]
    1 [9]
    0 [10]
    85
    0 [11]
    Completed
    229
    118
    173
    85
    105
    Not completed
    2
    1
    3
    0
    1
         Consent withdrawn by subject
    2
    1
    1
    -
    -
         Randomized by mistake without study treatment
    -
    -
    1
    -
    1
         Lost to follow-up
    -
    -
    1
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 1: V116 group participants could have been considered to complete the study without receipt of PCV15 on Day 1.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This participant inadvertently received V116 on Day 1. Cohort 1: PCV15 group participants could have been considered to complete the study without receipt of V116 on Day 1.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This participant inadvertently received PPSV23 on Day 1. Cohort 1: PCV15 group participants could have been considered to complete the study without receipt of PPSV23 on Day 1.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 2: V116 group participants could have been considered to complete the study without receipt of PCV15 on Day 1.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 2: V116 group participants could have been considered to complete the study without receipt of PPSV23 on Day 1.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 2: PPSV23 group participants could have been considered to complete the study without receipt of V116 on Day 1.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 2: PPSV23 group participants could have been considered to complete the study without receipt of PCV15 on Day 1.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 3: V116 group participants could have been considered to complete the study without receipt of PCV15 on Day 1.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 3: V116 group participants could have been considered to complete the study without receipt of PPSV23 on Day 1.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Cohort 1: V116 group participants could have been considered to complete the study without receipt of PPSV23 on Day 1.
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Two participants randomized to receive PCV115, inadvertently received incorrect vaccine on Day 1. Cohort 1: PCV15 group participants could have been considered to complete the study without receipt of V116 and PPSV23 on Day 1.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: V116
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.

    Reporting group title
    Cohort 1: PCV15
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.

    Reporting group title
    Cohort 2: V116
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.

    Reporting group title
    Cohort 2: PPSV23
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.

    Reporting group title
    Cohort 3: V116
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.

    Reporting group values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116 Total
    Number of subjects
    		 231 119 176 85 106 717
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 48 25 81 39 17 210
        From 65-84 years
    		 179 91 95 46 84 495
        85 years and over
    		 4 3 0 0 5 12
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 68.8 ( 7.5 ) 69.0 ( 7.1 ) 65.4 ( 7.8 ) 65.4 ( 6.6 ) 71.0 ( 7.6 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 117 60 101 49 56 383
        Male
    		 114 59 75 36 50 334
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0
        Asian
    		 96 47 55 25 13 236
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0
        Black or African American
    		 6 3 3 1 6 19
        White
    		 127 69 118 59 86 459
        More than one race
    		 2 0 0 0 1 3
        Unknown or Not Reported
    		 0 0 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 22 17 34 16 14 103
        Not Hispanic or Latino
    		 207 102 142 69 92 612
        Unknown or Not Reported
    		 2 0 0 0 0 2

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: V116
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 (pneumococcal vaccine, polyvalent [23-valent], PNEUMOVAX™23) prior to the enrollment.

    Reporting group title
    Cohort 1: PCV15
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™) on Day 1. Participants in this arm received PPSV23 prior to the enrollment.

    Reporting group title
    Cohort 2: V116
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) prior to the enrollment.

    Reporting group title
    Cohort 2: PPSV23
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.

    Reporting group title
    Cohort 3: V116
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.

    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) [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 5 days post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No between-group statistical analyses were performed for this endpoint.
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    230
    117
    174
    85
    105
    Units: Percentage of Participants
    number (not applicable)
        Injection site erythema
    7.4
    7.7
    7.5
    9.4
    7.6
        Injection site pain
    35.7
    43.6
    41.4
    47.1
    43.8
        Injection site swelling
    8.3
    8.5
    4.6
    16.5
    10.5
    No statistical analyses for this end point

    Primary: Percentage of Participants with Solicited Systemic AEs

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    End point title
    		 Percentage of Participants with Solicited Systemic AEs [2]
    End point description
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Up to 5 days post-vaccination
    Notes
    [2] - 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 between-group statistical analyses were performed for this endpoint.
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    230
    117
    174
    85
    105
    Units: Percentage of Participants
    number (not applicable)
        Fatigue
    14.3
    17.1
    19.0
    12.9
    21.9
        Headache
    7.0
    9.4
    10.3
    11.8
    8.6
        Myalgia
    7.4
    2.6
    9.8
    9.4
    8.6
        Pyrexia
    1.7
    2.6
    2.9
    1.2
    0.0
    No statistical analyses for this end point

    Primary: Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs) [3]
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, 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 another important medical event. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Up to ~180 days
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No between-group statistical analyses were performed for this endpoint.
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    230
    117
    174
    85
    105
    Units: Percentage of Participants
        number (not applicable)
    0.4
    0.0
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Primary: Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA)

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    End point title
    		 Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) [4]
    End point description
    OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Primary
    End point timeframe
    30 Days post-vaccination
    Notes
    [4] - 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 between-group statistical analyses were performed for this endpoint.
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    215
    115
    166
    78
    99
    Units: Titers
    geometric mean (confidence interval 95%)
        Serotype 3 (n=197, 103, 149, 75, 85)
    262.1 (224.0 to 306.8)
    226.3 (182.0 to 281.4)
    391.1 (332.8 to 459.6)
    583.1 (453.5 to 749.6)
    318.3 (250.0 to 405.3)
        Serotype 6A (n=191, 94, 152, 74, 93)
    1653.5 (1347.2 to 2029.4)
    2076.1 (1571.4 to 2742.8)
    3624.0 (3099.2 to 4237.7)
    1812.3 (1226.6 to 2677.6)
    2097.3 (1693.4 to 2597.6)
        Serotype 7F (n=209, 110, 150, 70, 96)
    2184.4 (1891.4 to 2522.8)
    1750.3 (1404.7 to 2181.0)
    3129.8 (2609.9 to 3753.3)
    4057.0 (3211.2 to 5125.6)
    2051.3 (1630.2 to 2581.0)
        Serotype 19A (n=204, 109, 158, 74, 93)
    1513.8 (1318.4 to 1738.1)
    2022.9 (1634.1 to 2504.3)
    2528.9 (2201.7 to 2904.9)
    3241.5 (2646.0 to 3971.0)
    1533.8 (1272.4 to 1848.9)
        Serotype 22F (n=206, 108, 143, 71, 99)
    1983.8 (1698.3 to 2317.4)
    1595.6 (1227.1 to 2074.6)
    4389.2 (3541.1 to 5440.3)
    2524.0 (1834.5 to 3472.5)
    1913.5 (1453.5 to 2519.0)
        Serotype 33F (n=188, 99, 131, 59, 88)
    4311.9 (3625.1 to 5128.9)
    3397.2 (2665.3 to 4330.0)
    8162.9 (6407.2 to 10399.7)
    8761.9 (6157.4 to 12468.1)
    4654.3 (3532.1 to 6133.1)
        Serotype 8 (n=208, 113, 161, 75, 98)
    1273.0 (1115.1 to 1453.3)
    345.8 (250.5 to 477.5)
    2320.1 (1987.3 to 2708.7)
    2723.2 (2197.4 to 3374.8)
    1486.8 (1230.5 to 1796.6)
        Serotype 9N (n=191, 111, 143, 58, 90)
    3805.1 (3324.0 to 4356.0)
    2176.5 (1809.6 to 2617.9)
    7214.4 (6062.9 to 8584.6)
    6482.5 (4908.9 to 8560.7)
    4054.5 (3389.4 to 4850.2)
        Serotype 10A n=209, 112, 155, 73, 96)
    1986.2 (1637.7 to 2408.9)
    467.5 (337.0 to 648.5)
    3976.8 (3360.7 to 4705.8)
    1797.6 (1136.2 to 2843.9)
    2564.0 (1959.1 to 3355.6)
        Serotype 11A (n=197, 100, 142, 71, 87)
    1998.5 (1696.9 to 2353.8)
    335.6 (228.9 to 491.8)
    2846.6 (2411.0 to 3360.8)
    1736.6 (1367.1 to 2206.1)
    2373.0 (1905.4 to 2955.4)
        Serotype 12F (n=212, 114, 160, 73, 99)
    981.8 (782.4 to 1232.1)
    80.5 (54.0 to 120.1)
    2252.6 (2120.5 to 3072.9)
    1402.5 (912.2 to 2156.4)
    1235.3 (948.3 to 1609.2)
        Serotype 15A (n=175, 93, 134, 63, 86)
    4184.9 (3548.3 to 4935.6)
    877.2 (616.2 to 1248.7)
    6185.2 (5179.3 to 7386.6)
    1668.2 (1234.4 to 2254.5)
    4328.6 (3378.7 to 5545.7)
        Serotype 15C (n= 206, 110, 152, 72, 89)
    2307.8 (1878.4 to 2835.4)
    539.6 (371.1 to 784.6)
    4334.4 (3563.8 to 5271.5)
    1470.4 (978.6 to 2209.3)
    2191.9 (1573.2 to 3053.9)
        Serotype 16F (n=187, 107, 146, 74, 89)
    3060.5 (2633.8 to 3556.3)
    392.3 (301.3 to 510.8)
    4626.5 (3861.8 to 5542.6)
    832.8 (604.3 to 1147.6)
    2477.0 (1887.2 to 3251.2)
        Serotype 17F (n=194, 108, 125, 67, 82)
    3599.8 (3134.5 to 4134.3)
    939.6 (693.7 to 1272.6)
    5963.8 (5036.6 to 7061.7)
    4367.3 (3372.5 to 5655.7)
    3836.7 (3063.4 to 4805.1)
        Serotype 20A (n=195, 110, 138, 72, 88)
    2847.4 (2433.3 to 3331.8)
    1058.9 (829.9 to 1351.1)
    6005.5 (4919.8 to 7330.8)
    3393.9 (2536.9 to 4540.5)
    2433.4 (1880.5 to 3148.9)
        Serotype 23A (n=202, 91, 156, 60, 86)
    2363.9 (1857.4 to 3008.5)
    310.2 (202.1 to 476.0)
    4253.4 (3417.6 to 5293.5)
    433.6 (247.5 to 759.5)
    3967.2 (2764.8 to 5692.7)
        Serotype 23B (n=197, 110, 160, 75, 97)
    673.2 (517.1 to 876.4)
    153.0 (98.7 to 237.1)
    1530.7 (1196.5 to 1958.3)
    203.9 (127.6 to 325.6)
    844.0 (608.2 to 1171.4)
        Serotype 24F (n=201, 97, 151, 63, 90)
    1822.6 (1411.6 to 2353.3)
    106.6 (69.7 to 162.9)
    2746.1 (2257.9 to 3339.9)
    48.5 (28.6 to 82.1)
    2041.5 (1500.8 to 2777.1)
        Serotype 31 (n=194, 108, 146, 68, 90)
    3018.4 (2473.6 to 3683.3)
    113.2 (74.5 to 172.1)
    4413.5 (3530.2 to 5517.7)
    171.8 (99.9 to 295.6)
    3285.5 (2485.0 to 4343.8)
        Serotype 35B (n=194, 107, 148, 76, 90)
    6703.1 (5732.7 to 7837.8)
    1019.1 (739.9 to 1403.7)
    8143.5 (6761.4 to 9808.1)
    1527.7 (1169.5 to 1995.5)
    5836.8 (4693.6 to 7258.6)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)

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    End point title
    		 Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
    End point description
    The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    30 Days post-vaccination
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    220
    117
    167
    81
    99
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 3 (n=220, 117, 167, 81, 99)
    0.87 (0.77 to 0.99)
    0.80 (0.65 to 0.97)
    0.89 (0.77 to 1.03)
    1.58 (1.25 to 2.00)
    0.85 (0.70 to 1.03)
        Serotype 6A (219, 117, 167, 81, 99)
    4.69 (3.72 to 5.90)
    7.69 (5.60 to 10.57)
    7.81 (6.30 to 9.68)
    5.24 (3.62 to 7.56)
    5.48 (4.27 to 7.03)
        Serotype 7F (219, 117, 167, 81, 99)
    5.71 (4.89 to 6.68)
    6.45 (5.08 to 8.19)
    5.65 (4.75 to 6.73)
    8.34 (6.57 to 10.59)
    5.07 (4.12 to 6.23)
        Serotype 19A (219, 117, 167, 81, 99)
    8.54 (7.33 to 9.95)
    11.97 (9.40 to 15.24)
    9.12 (7.70 to 10.81)
    12.41 (9.57 to 16.11)
    8.06 (6.50 to 9.98)
        Serotype 22F (n=219, 117, 167, 81, 99)
    4.41 (3.69 to 5.28)
    4.33 (3.37 to 5.56)
    5.38 (4.34 to 6.66)
    2.87 (2.12 to 3.87)
    3.08 (2.36 to 4.01)
        Serotype 33F (n=220, 117, 167, 81, 99)
    13.36 (11.22 to 15.91)
    12.72 (10.37 to 15.61)
    15.04 (12.31 to 18.37)
    13.92 (10.23 to 18.94)
    9.66 (7.53 to 12.40)
        Serotype 8 (n=220, 117, 167, 81, 99)
    9.58 (8.21 to 11.17)
    3.56 (2.74 to 4.62)
    11.29 (9.28 to 13.73)
    14.47 (10.86 to 19.27)
    7.48 (5.87 to 9.53)
        Serotype 9N (n=217, 117, 167, 81, 99)
    7.06 (5.92 to 8.43)
    3.59 (2.83 to 4.55)
    8.48 (6.89 to 10.44)
    7.32 (5.47 to 9.78)
    4.15 (3.23 to 5.34)
        Serotype 10A (n=220, 117, 167, 81, 99)
    9.86 (7.99 to 12.18)
    2.77 (2.12 to 3.63)
    18.21 (14.30 to 23.18)
    7.29 (4.94 to 10.74)
    10.03 (7.21 to 13.98)
        Serotype 11A (n=219, 117, 167, 81, 99)
    7.16 (6.09 to 8.42)
    2.06 (1.65 to 2.58)
    9.13 (7.44 to 11.22)
    3.95 (2.98 to 5.23)
    4.78 (3.79 to 6.03)
        Serotype 12F (n=220, 117, 167, 81, 99)
    1.46 (1.18 to 1.81)
    0.41 (0.30 to 0.55)
    1.91 (1.44 to 2.53)
    1.01 (0.65 to 1.56)
    0.96 (0.70 to 1.31)
        Serotype 15A (n=220, 117, 167, 81, 99)
    16.35 (13.45 to 19.88)
    1.56 (1.19 to 2.05)
    20.24 (15.92 to 25.75)
    2.15 (1.52 to 3.03)
    11.16 (7.91 to 15.75)
        Serotype 15C (n=219, 117, 166, 81, 99)
    11.08 (9.01 to 13.62)
    3.25 (2.37 to 4.45)
    16.67 (12.78 to 21.76)
    4.31 (2.91 to 6.38)
    6.51 (4.72 to 8.99)
        Serotype 16F (n=218, 117, 166, 81, 99)
    4.69 (3.75 to 5.87)
    0.37 (0.28 to 0.48)
    4.04 (3.19 to 5.10)
    0.30 (0.22 to 0.41)
    2.46 (1.78 to 3.41)
        Serotype 17F (n=219, 117, 167, 81, 99)
    13.20 (11.18 to 15.58)
    2.68 (2.08 to 3.46)
    14.96 (12.37 to 18.08)
    7.23 (5.26 to 9.92)
    9.92 (7.86 to 12.53)
        Serotype 20A (n=219, 117, 167, 81, 99)
    14.83 (12.37 to 17.77)
    4.93 (3.83 to 6.36)
    22.21 (17.77 to 27.75)
    10.73 (7.48 to 15.41)
    12.16 (8.99 to 16.46)
        Serotype 23A (n=219, 117, 166, 81, 99)
    5.38 (4.19 to 6.90)
    0.75 (0.55 to 1.02)
    6.03 (4.55 to 7.99)
    0.62 (0.43 to 0.90)
    4.25 (2.88 to 6.26)
        Serotype 23B (n=219, 117, 167, 81, 99)
    6.66 (5.53 to 8.03)
    2.61 (1.96 to 3.48)
    6.00 (4.91 to 7.33)
    2.31 (1.75 to 3.06)
    5.05 (3.90 to 6.54)
        Serotype 24F (n=219, 117, 167, 81, 99)
    10.05 (7.59 to 13.32)
    0.49 (0.39 to 0.61)
    7.48 (5.45 to 10.46)
    0.31 (0.23 to 0.42)
    6.12 (3.84 to 9.75)
        Serotype 31 (n=217, 117, 167, 81, 99)
    4.48 (3.66 to 5.48)
    0.37 (0.30 to 0.47)
    3.58 (2.87 to 4.46)
    0.32 (0.24 to 0.44)
    3.66 (2.64 to 5.08)
        Serotype 35B (n=218, 117, 167, 81, 99)
    26.31 (21.60 to 32.04)
    1.45 (1.18 to 1.78)
    24.55 (20.09 to 30.01)
    1.45 (1.17 to 1.80)
    18.15 (13.61 to 24.21)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)

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    End point title
    		 Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA)
    End point description
    Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and 30 days post-vaccination
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    212
    115
    164
    76
    98
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 3 (n=164, 91, 131, 68, 76)
    4.4 (3.7 to 5.3)
    4.0 (3.1 to 5.3)
    6.2 (5.0 to 7.6)
    7.5 (5.3 to 10.5)
    5.0 (3.6 to 7.0)
        Serotype 6A (n=171, 87, 136, 66, 89)
    6.2 (5.0 to 7.7)
    7.1 (4.9 to 10.3)
    4.2 (3.3 to 5.3)
    1.8 (1.4 to 2.4)
    5.5 (4.1 to 7.4)
        Serotype 7F (n=200, 102, 146, 69, 92)
    4.1 (3.3 to 5.1)
    3.9 (2.8 to 5.4)
    4.6 (3.6 to 5.9)
    4.2 (3.1 to 5.8)
    3.9 (2.9 to 5.3)
        Serotype 19A (n=194, 104, 149, 72, 90)
    2.4 (2.0 to 2.8)
    3.3 (2.5 to 4.4)
    2.8 (2.3 to 3.3)
    3.6 (2.7 to 4.7)
    2.5 (1.8 to 3.3)
        Serotype 22F (n=193, 102, 124, 64, 94)
    7.0 (5.5 to 9.0)
    7.1 (4.8 to 10.6)
    26.3 (17.7 to 39.2)
    14.8 (8.7 to 25.1)
    7.5 (4.9 to 11.4)
        Serotype 33F (n=177, 93, 125, 50, 85)
    2.2 (1.8 to 2.6)
    1.7 (1.3 to 2.4)
    6.3 (4.8 to 8.4)
    9.2 (5.6 to 15.3)
    2.7 (2.0 to 3.7)
        Serotype 8 (n=198, 108, 151, 71, 96)
    2.8 (2.4 to 3.4)
    0.9 (0.7 to 1.0)
    16.6 (12.2 to 22.7)
    18.6 (11.9 to 29.1)
    3.8 (2.7 to 5.3)
        Serotype 9N (n=186, 108, 136, 53, 87)
    2.3 (2.0 to 2.7)
    1.4 (1.1 to 1.7)
    5.9 (4.7 to 7.4)
    6.8 (4.7 to 9.8)
    3.5 (2.7 to 4.5)
        Serotype 10A (n=200, 111, 148, 71, 93)
    4.3 (3.5 to 5.4)
    1.0 (0.9 to 1.2)
    17.1 (12.7 to 23.0)
    11.8 (7.5 to 18.6)
    4.7 (3.4 to 6.5)
        Serotype 11A (n=186, 91, 131, 65, 83)
    6.5 (5.2 to 8.2)
    1.2 (0.9 to 1.7)
    21.0 (14.6 to 30.4)
    9.2 (5.9 to 14.4)
    9.5 (6.2 to 14.4)
        Serotype 12F (n=207, 112, 157, 72, 93)
    11.8 (9.0 to 15.4)
    1.1 (1.0 to 1.3)
    82.2 (62.9 to 107.4)
    41.9 (26.1 to 67.2)
    13.7 (9.0 to 20.8)
        Serotype 15A (n=142, 78, 110, 40, 62)
    5.6 (4.3 to 7.4)
    1.2 (0.9 to 1.5)
    9.0 (6.8 to 11.8)
    3.0 (2.0 to 4.5)
    7.2 (4.6 to 11.2)
        Serotype 15C (n=197, 108, 141, 68, 82)
    8.5 (6.7 to 10.9)
    1.3 (1.0 to 1.7)
    30.6 (22.5 to 41.5)
    12.7 (8.5 to 18.8)
    11.6 (8.1 to 16.4)
        Serotype 16F (n=172, 100, 132, 68, 86)
    7.1 (5.9 to 8.5)
    1.1 (0.9 to 1.3)
    9.8 (7.8 to 12.4)
    2.0 (1.5 to 2.7)
    7.2 (5.5 to 9.6)
        Serotype 17F (n=183, 101, 116, 64, 79)
    3.7 (3.0 to 4.5)
    0.9 (0.8 to 1.1)
    13.5 (9.5 to 19.2)
    8.1 (5.6 to 11.7)
    6.5 (4.6 to 9.3)
        Serotype 20A (n=184, 105, 129, 69, 81)
    3.7 (3.0 to 4.5)
    0.9 (0.8 to 1.0)
    12.2 (9.3 to 16.0)
    6.0 (4.4 to 8.3)
    4.4 (3.1 to 6.1)
        Serotype 23A (n=157, 76, 118, 38, 65)
    8.4 (6.2 to 11.6)
    1.4 (1.0 to 1.9)
    19.0 (13.5 to 26.9)
    2.5 (1.3 to 4.9)
    16.3 (10.3 to 25.7)
        Serotype 23B (n=191, 109, 155, 71, 94)
    21.4 (16.2 to 28.1)
    4.2 (2.9 to 6.0)
    35.5 (25.9 to 48.6)
    5.2 (3.5 to 7.6)
    26.1 (17.5 to 38.9)
        Serotype 24F (n=187, 91, 127, 61, 82)
    25.8 (19.5 to 34.0)
    1.0 (0.8 to 1.3)
    31.1 (22.8 to 42.6)
    0.9 (0.7 to 1.3)
    39.5 (27.4 to 56.9)
        Serotype 31 (n=179, 97, 134, 61, 84)
    16.7 (12.5 to 22.3)
    0.9 (0.7 to 1.2)
    35.6 (24.8 to 51.2)
    1.7 (1.1 to 2.6)
    30.5 (19.1 to 48.6)
        Serotype 35B (n=183, 106, 144, 71, 85)
    6.0 (4.8 to 7.4)
    1.0 (0.8 to 1.2)
    7.2 (5.6 to 9.2)
    1.4 (1.1 to 1.8)
    5.7 (4.2 to 7.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses

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    End point title
    		 Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses
    End point description
    Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and 30 days post-vaccination
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    212
    115
    164
    76
    98
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 3 (n=164, 91, 131, 68, 76)
    54.9 (46.9 to 62.6)
    54.9 (44.2 to 65.4)
    64.1 (55.3 to 72.3)
    66.2 (53.7 to 77.2)
    48.7 (37.0 to 60.4)
        Serotype 6A (n=171, 87, 136, 66, 89)
    57.9 (50.1 to 65.4)
    58.6 (47.6 to 69.1)
    46.3 (37.7 to 55.1)
    18.2 (9.8 to 29.6)
    56.2 (45.3 to 66.7)
        Serotype 7F (n=200, 102, 146, 69, 92)
    38.5 (31.7 to 45.6)
    43.1 (33.4 to 53.3)
    44.5 (36.3 to 53.0)
    49.3 (37.0 to 61.6)
    38.0 (28.1 to 48.8)
        Serotype 19A (n=194, 104, 149, 72, 90)
    28.4 (22.1 to 35.2)
    34.6 (25.6 to 44.6)
    33.6 (26.0 to 41.7)
    38.9 (27.6 to 51.1)
    30.0 (20.8 to 40.6)
        Serotype 22F (n=193, 102, 124, 64, 94)
    53.9 (46.6 to 61.1)
    54.9 (44.7 to 64.8)
    77.4 (69.0 to 84.4)
    65.6 (52.7 to 77.1)
    50.0 (39.5 to 60.5)
        Serotype 33F (n=177, 93, 125, 50, 85)
    19.8 (14.2 to 26.4)
    19.4 (11.9 to 28.9)
    52.0 (42.9 to 61.0)
    56.0 (41.3 to 70.0)
    29.4 (20.0 to 40.3)
        Serotype 8 (n=198, 108, 151, 71, 96)
    33.3 (26.8 to 40.4)
    2.8 (0.6 to 7.9)
    70.2 (62.2 to 77.4)
    74.6 (62.9 to 84.2)
    34.4 (25.0 to 44.8)
        Serotype 9N (n=186, 108, 136, 53, 87)
    22.0 (16.3 to 28.7)
    6.5 (2.6 to 12.9)
    57.4 (48.6 to 65.8)
    67.9 (53.7 to 80.1)
    39.1 (28.8 to 50.1)
        Serotype 10A (n=200, 111, 148, 71, 93)
    46.0 (38.9 to 53.2)
    2.7 (0.6 to 7.7)
    74.3 (66.5 to 81.1)
    67.6 (55.5 to 78.2)
    49.5 (38.9 to 60.0)
        Serotype 11A (n=186, 91, 131, 65, 83)
    53.8 (46.3 to 61.1)
    12.1 (6.2 to 20.6)
    73.3 (64.8 to 80.6)
    53.8 (41.0 to 66.3)
    59.0 (47.7 to 69.7)
        Serotype 12F (n=207, 112, 157, 72, 93)
    62.8 (55.8 to 69.4)
    6.3 (2.5 to 12.5)
    93.0 (87.8 to 96.5)
    81.9 (71.1 to 90.0)
    60.2 (49.5 to 70.2)
        Serotype 15A (n=142, 78, 110, 40, 62)
    53.5 (45.0 to 61.9)
    12.8 (6.3 to 22.3)
    70.9 (61.5 to 79.2)
    35.0 (20.6 to 51.7)
    59.7 (46.4 to 71.9)
        Serotype 15C (n=197, 108, 141, 68, 82)
    61.4 (54.2 to 68.3)
    10.2 (5.2 to 17.5)
    84.4 (77.3 to 90.0)
    72.1 (59.9 to 82.3)
    72.0 (60.9 to 81.3)
        Serotype 16F (n=172, 100, 132, 68, 86)
    68.0 (60.5 to 74.9)
    8.0 (3.5 to 15.2)
    70.5 (61.9 to 78.1)
    30.9 (20.2 to 43.3)
    70.9 (60.1 to 80.2)
        Serotype 17F (n=183, 101, 116, 64, 79)
    37.7 (30.7 to 45.2)
    2.0 (0.2 to 7.0)
    74.1 (65.2 to 81.8)
    62.5 (49.5 to 74.3)
    54.4 (42.8 to 65.7)
        Serotype 20A (n=184, 105, 129, 69, 81
    37.5 (30.5 to 44.9)
    2.9 (0.6 to 8.1)
    76.7 (68.5 to 83.7)
    60.9 (48.4 to 72.4)
    46.9 (35.7 to 58.3)
        Serotype 23A (n=157, 76, 118, 38, 65)
    59.9 (51.8 to 67.6)
    21.1 (12.5 to 31.9)
    73.7 (64.8 to 81.4)
    34.2 (19.6 to 51.4)
    80.0 (68.2 to 88.9)
        Serotype 23B (n=191, 109, 155, 71, 94)
    74.9 (68.1 to 80.9)
    40.4 (31.1 to 50.2)
    80.6 (73.5 to 86.5)
    43.7 (31.9 to 56.0)
    80.9 (71.4 to 88.2)
        Serotype 24F (n=187, 91, 127, 61, 82)
    80.2 (73.8 to 85.7)
    7.7 (3.1 to 15.2)
    81.9 (74.1 to 88.2)
    4.9 (1.0 to 13.7)
    89.0 (80.2 to 94.9)
        Serotype 31 (n=179, 97, 134, 61, 84)
    70.9 (63.7 to 77.5)
    8.2 (3.6 to 15.6)
    81.3 (73.7 to 87.5)
    18.0 (9.4 to 30.0)
    82.1 (72.3 to 89.6)
        Serotype 35B (n=183, 106, 144, 71, 85)
    55.2 (47.7 to 62.5)
    7.5 (3.3 to 14.3)
    65.3 (56.9 to 73.0)
    7.0 (2.3 to 15.7)
    57.6 (46.4 to 68.3)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise of Serotype-specific IgG

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    End point title
    		 Geometric Mean Fold Rise of Serotype-specific IgG
    End point description
    Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and 30 days post-vaccination
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    220
    117
    167
    81
    99
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 3 (n=220, 117, 167, 81, 99)
    3.6 (3.2 to 4.0)
    3.1 (2.6 to 3.7)
    3.7 (3.2 to 4.3)
    5.7 (4.3 to 7.4)
    2.9 (2.3 to 3.5)
        Serotype 6A (n=219, 117, 167, 81, 99)
    5.9 (5.0 to 7.1)
    8.0 (6.1 to 10.6)
    3.3 (2.7 to 4.0)
    2.5 (1.9 to 3.2)
    4.4 (3.4 to 5.7)
        Serotype 7F (n=219, 117, 167, 81, 99)
    3.3 (2.8 to 3.8)
    2.9 (2.3 to 3.5)
    3.2 (2.7 to 3.8)
    3.2 (2.6 to 3.9)
    3.2 (2.6 to 4.0)
        Serotype 19A (n=219, 117, 167, 81, 99)
    2.3 (2.0 to 2.7)
    3.4 (2.8 to 4.2)
    2.2 (1.9 to 2.5)
    3.0 (2.4 to 3.6)
    2.0 (1.7 to 2.4)
        Serotype 22F (n=219, 117, 167, 81, 99)
    4.2 (3.6 to 4.9)
    3.4 (2.8 to 4.2)
    14.3 (11.4 to 18.0)
    8.5 (6.2 to 11.6)
    3.5 (2.7 to 4.6)
        Serotype 33F (n=220, 117, 167, 81, 99)
    2.2 (1.9 to 2.5)
    1.8 (1.5 to 2.1)
    8.6 (7.1 to 10.5)
    10.5 (7.9 to 13.9)
    2.4 (1.9 to 3.0)
        Serotype 8 (n=220, 117, 167, 81, 99)
    2.7 (2.4 to 3.1)
    1.0 (0.9 to 1.1)
    12.1 (9.8 to 15.0)
    14.4 (10.3 to 20.0)
    2.3 (1.9 to 2.8)
        Serotype 9N (n=217, 117, 167, 81, 99)
    2.9 (2.4 to 3.4)
    1.4 (1.2 to 1.6)
    8.7 (7.1 to 10.6)
    9.1 (6.8 to 12.1)
    3.2 (2.6 to 3.9)
        Serotype 10A (n=220, 117, 167, 81, 99)
    4.4 (3.7 to 5.2)
    1.0 (0.9 to 1.0)
    18.9 (15.3 to 23.4)
    10.1 (7.6 to 13.4)
    4.2 (3.1 to 5.5)
        Serotype 11A (n=219, 117, 167, 81, 99)
    4.1 (3.6 to 4.7)
    1.0 (0.9 to 1.0)
    10.3 (8.5 to 12.6)
    5.6 (4.4 to 7.2)
    3.5 (2.7 to 4.3)
        Serotype 12F (n=220, 117, 167, 81, 99)
    4.2 (3.6 to 5.0)
    1.0 (0.9 to 1.1)
    14.2 (11.3 to 17.9)
    8.4 (5.8 to 12.0)
    3.5 (2.7 to 4.5)
        Serotype 15A (n=220, 117, 167, 81, 99)
    12.2 (10.1 to 14.7)
    1.0 (0.9 to 1.1)
    24.5 (19.7 to 30.3)
    2.4 (2.0 to 3.0)
    16.6 (12.0 to 22.9)
        Serotype 15C (n=219, 117, 166, 81, 99)
    5.8 (4.9 to 6.9)
    1.0 (0.9 to 1.2)
    18.8 (14.9 to 23.8)
    6.2 (4.8 to 8.2)
    6.4 (5.0 to 8.1)
        Serotype 16F (n=218, 117, 166, 81, 99)
    15.2 (12.7 to 18.2)
    1.1 (1.0 to 1.2)
    15.7 (12.9 to 19.0)
    1.6 (1.3 to 1.8)
    11.9 (9.2 to 15.4)
        Serotype 17F (n=219, 117, 167, 81, 99)
    4.7 (4.0 to 5.5)
    1.0 (0.9 to 1.1)
    17.4 (14.3 to 21.1)
    10.5 (7.8 to 14.1)
    3.8 (2.9 to 5.0)
        Serotype 20A (n=219, 117, 167, 81, 99)
    3.8 (3.3 to 4.4)
    1.0 (0.9 to 1.1)
    14.8 (12.2 to 17.9)
    8.5 (6.4 to 11.4)
    3.7 (2.9 to 4.8)
        Serotype 23A (n=219, 117, 167, 81, 99)
    13.5 (11.1 to 16.5)
    1.8 (1.5 to 2.2)
    18.9 (15.3 to 23.4)
    2.3 (1.9 to 2.7)
    13.1 (9.6 to 17.7)
        Serotype 23B (n=219, 117, 167, 81, 99)
    8.2 (6.7 to 10.0)
    2.7 (2.1 to 3.5)
    7.3 (6.0 to 8.9)
    2.3 (1.9 to 2.9)
    7.3 (5.4 to 9.7)
        Serotype 24F (n=219, 117, 167, 81, 99)
    26.9 (21.8 to 33.1)
    1.0 (0.9 to 1.1)
    21.7 (17.3 to 27.2)
    1.0 (0.9 to 1.1)
    24.4 (17.1 to 34.9)
        Serotype 31 (n=217, 117, 167, 81, 90)
    13.1 (11.0 to 15.6)
    1.1 (1.0 to 1.2)
    14.4 (11.9 to 17.3)
    1.5 (1.3 to 1.8)
    13.0 (9.9 to 17.0)
        Serotype 35B (n=218, 117, 167, 81, 99)
    16.8 (13.9 to 20.3)
    1.0 (0.9 to 1.0)
    15.6 (12.9 to 18.7)
    0.9 (0.9 to 1.0)
    15.7 (11.9 to 20.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response

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    End point title
    		 Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific IgG Response
    End point description
    Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a ≥4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented. All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
    End point type
    Secondary
    End point timeframe
    Day 1 (Baseline) and 30 days post-vaccination
    End point values
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Number of subjects analysed
    220
    117
    167
    81
    99
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 3 (n=220, 117, 167, 81, 99)
    42.7 (36.1 to 49.6)
    36.8 (28.0 to 46.2)
    40.7 (33.2 to 48.6)
    54.3 (42.9 to 65.4)
    35.4 (26.0 to 45.6)
        Serotype 6A (n=219, 117, 167, 81, 99)
    56.2 (49.3 to 62.8)
    65.0 (55.6 to 73.5)
    35.9 (28.7 to 43.7)
    27.2 (17.9 to 38.2)
    45.5 (35.4 to 55.8)
        Serotype 7F (n=219, 117, 167, 81, 99)
    34.7 (28.4 to 41.4)
    29.9 (21.8 to 39.1)
    37.7 (30.4 to 45.5)
    33.3 (23.2 to 44.7)
    37.4 (27.9 to 47.7)
        Serotype 19A (n=219, 117, 167, 81, 99)
    24.7 (19.1 to 30.9)
    37.6 (28.8 to 47.0)
    19.8 (14.0 to 26.6)
    33.3 (23.2 to 44.7)
    19.2 (12.0 to 28.3)
        Serotype 22F (n=219, 117, 167, 81, 99)
    39.3 (32.8 to 46.1)
    35.0 (26.5 to 44.4)
    78.4 (71.4 to 84.4)
    65.4 (54.0 to 75.7)
    43.4 (33.5 to 53.8)
        Serotype 33F (n=220, 117, 167, 81, 99)
    19.1 (14.1 to 24.9)
    12.8 (7.4 to 20.3)
    72.5 (65.0 to 79.1)
    75.3 (64.5 to 84.2)
    27.3 (18.8 to 37.1)
        Serotype 8 (n=220, 117, 167, 81, 99)
    29.5 (23.6 to 36.0)
    0.9 (0.0 to 4.7)
    78.4 (71.4 to 84.4)
    76.5 (65.8 to 85.2)
    26.3 (17.9 to 36.1)
        Serotype 9N (n=217, 117, 167, 81, 99)
    31.8 (25.7 to 38.4)
    7.7 (3.6 to 14.1)
    68.9 (61.2 to 75.8)
    72.8 (61.8 to 82.1)
    36.4 (26.9 to 46.6)
        Serotype 10A (n=220, 117, 167, 81, 99)
    45.5 (38.7 to 52.3)
    0.9 (0.0 to 4.7)
    82.6 (76.0 to 88.1)
    80.2 (69.9 to 88.3)
    46.5 (36.4 to 56.8)
        Serotype 11A (n=219, 117, 167, 81, 99)
    43.8 (37.2 to 50.7)
    0.0 (0.0 to 3.1)
    72.5 (65.0 to 79.1)
    63.0 (51.5 to 73.4)
    43.4 (33.5 to 53.8)
        Serotype 12F (n=220, 117, 167, 81, 99)
    44.5 (37.9 to 51.4)
    2.6 (0.5 to 7.3)
    75.4 (68.2 to 81.8)
    60.5 (49.0 to 71.2)
    39.4 (29.7 to 49.7)
        Serotype 15A (n=220, 117, 167, 81, 99)
    73.6 (67.3 to 79.3)
    0.9 (0.0 to 4.7)
    89.8 (84.2 to 94.0)
    28.4 (18.9 to 39.5)
    77.8 (68.3 to 85.5)
        Serotype 15C (n=219, 117, 166, 81, 99)
    57.5 (50.7 to 64.2)
    3.4 (0.9 to 8.5)
    80.1 (73.2 to 85.9)
    64.2 (52.8 to 74.6)
    66.7 (56.5 to 75.8)
        Serotype 16F (n=218, 117, 166, 81, 99)
    82.1 (76.4 to 87.0)
    2.6 (0.5 to 7.3)
    84.9 (78.6 to 90.0)
    13.6 (7.0 to 23.0)
    77.8 (68.3 to 85.5)
        Serotype 17F (n=219, 117, 167, 81, 99)
    48.9 (42.1 to 55.7)
    1.7 (0.2 to 6.0)
    83.8 (77.4 to 89.1)
    74.1 (63.1 to 83.2)
    44.4 (34.5 to 54.8)
        Serotype 20A (n=219, 117, 167, 81, 99)
    36.5 (30.1 to 43.3)
    0.9 (0.0 to 4.7)
    83.2 (76.7 to 88.6)
    69.1 (57.9 to 78.9)
    49.5 (39.3 to 59.7)
        Serotype 23A (n=219, 117, 166, 81, 99)
    77.6 (71.5 to 83.0)
    17.1 (10.8 to 25.2)
    86.7 (80.6 to 91.5)
    21.0 (12.7 to 31.5)
    77.8 (68.3 to 85.5)
        Serotype 23B (n=219, 117, 167, 81, 99)
    64.8 (58.1 to 71.2)
    26.5 (18.8 to 35.5)
    60.5 (52.6 to 67.9)
    21.0 (12.7 to 31.5)
    64.6 (54.4 to 74.0)
        Serotype 24F (n=219, 117, 167, 81, 99)
    85.4 (80.0 to 89.8)
    0.0 (0.0 to 3.1)
    88.0 (82.1 to 92.5)
    0.0 (0.0 to 4.5)
    83.8 (75.1 to 90.5)
        Serotype 31 (n=217, 117, 167, 81, 99)
    79.7 (73.8 to 84.9)
    2.6 (0.5 to 7.3)
    84.4 (78.0 to 89.6)
    11.1 (5.2 to 20.0)
    80.8 (71.7 to 88.0)
        Serotype 35B (n=218, 117, 167, 81, 99)
    83.9 (78.4 to 88.6)
    0.0 (0.0 to 3.1)
    82.6 (76.0 to 88.1)
    0.0 (0.0 to 4.5)
    84.8 (76.2 to 91.3)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to approximately 30 days post-vaccination for non-serious adverse events (AEs) and up to approximately 180 days for serious AEs and deaths.
    Adverse event reporting additional description
    The analysis population for deaths (all-causes) included all randomized participants (N=231, N=119, N=176, N=85, N=106). The analysis population for AEs included all randomized participants who received the study vaccination.
    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
    		 -

    Reporting group title
    Cohort 1: PCV15
    Reporting group description
    		 -

    Reporting group title
    Cohort 2: V116
    Reporting group description
    		 -

    Reporting group title
    Cohort 2: PPSV23
    Reporting group description
    		 -

    Reporting group title
    Cohort 3: V116
    Reporting group description
    		 -

    Serious adverse events
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 230 (0.87%)
    4 / 117 (3.42%)
    2 / 174 (1.15%)
    3 / 85 (3.53%)
    2 / 105 (1.90%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 117 (0.85%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (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
    Cardiac failure congestive
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 117 (0.00%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (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
    Cardiac failure
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 117 (0.85%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 117 (0.85%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (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
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 117 (0.00%)
    0 / 174 (0.00%)
    1 / 85 (1.18%)
    0 / 105 (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
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 117 (0.00%)
    1 / 174 (0.57%)
    0 / 85 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortoenteric fistula
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 117 (0.85%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (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
    Small intestinal perforation
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 117 (0.85%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (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
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 117 (0.85%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (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
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 117 (0.00%)
    0 / 174 (0.00%)
    1 / 85 (1.18%)
    0 / 105 (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
    Cholelithiasis
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 117 (0.00%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    1 / 105 (0.95%)
         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
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 117 (0.00%)
    1 / 174 (0.57%)
    1 / 85 (1.18%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Injection site cellulitis
         subjects affected / exposed
    1 / 230 (0.43%)
    0 / 117 (0.00%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
         subjects affected / exposed
    0 / 230 (0.00%)
    1 / 117 (0.85%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    0 / 105 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 230 (0.00%)
    0 / 117 (0.00%)
    0 / 174 (0.00%)
    0 / 85 (0.00%)
    1 / 105 (0.95%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: V116 Cohort 1: PCV15 Cohort 2: V116 Cohort 2: PPSV23 Cohort 3: V116
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 230 (46.52%)
    66 / 117 (56.41%)
    85 / 174 (48.85%)
    52 / 85 (61.18%)
    51 / 105 (48.57%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 230 (7.39%)
    11 / 117 (9.40%)
    18 / 174 (10.34%)
    10 / 85 (11.76%)
    9 / 105 (8.57%)
         occurrences all number
    17
    11
    19
    10
    9
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    33 / 230 (14.35%)
    20 / 117 (17.09%)
    33 / 174 (18.97%)
    12 / 85 (14.12%)
    23 / 105 (21.90%)
         occurrences all number
    33
    20
    34
    12
    23
    Injection site erythema
         subjects affected / exposed
    19 / 230 (8.26%)
    9 / 117 (7.69%)
    14 / 174 (8.05%)
    8 / 85 (9.41%)
    8 / 105 (7.62%)
         occurrences all number
    19
    9
    14
    8
    8
    Injection site pain
         subjects affected / exposed
    82 / 230 (35.65%)
    51 / 117 (43.59%)
    72 / 174 (41.38%)
    40 / 85 (47.06%)
    46 / 105 (43.81%)
         occurrences all number
    82
    51
    72
    40
    46
    Injection site swelling
         subjects affected / exposed
    20 / 230 (8.70%)
    10 / 117 (8.55%)
    8 / 174 (4.60%)
    14 / 85 (16.47%)
    11 / 105 (10.48%)
         occurrences all number
    20
    10
    8
    14
    11
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    17 / 230 (7.39%)
    5 / 117 (4.27%)
    17 / 174 (9.77%)
    9 / 85 (10.59%)
    9 / 105 (8.57%)
         occurrences all number
    17
    5
    17
    9
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Jul 2022
    Amendment 03: Primary reason for amendment was to revise cohort-specific enrollment restrictions.

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

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