Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Adults Living With HIV

    Summary
    EudraCT number
    		 2021-006710-36
    Trial protocol
    		 BE   FR  
    Global end of trial date
    25 Jan 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jun 2025
    First version publication date
    06 Jun 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    v116-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05393037
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme LLC
    Sponsor organisation address
    126 East Lincoln Avenue, P.O. Box 2000, Rahway, NJ, United States, 07065
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme LLC, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Jan 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Jul 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jan 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the safety, tolerability, and immunogenicity of a pneumococcal 21-valent conjugate vaccine (V116) in persons living with human immunodeficiency virus (HIV), for the prevention of pneumococcal disease caused by the serotypes in the vaccine.
    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
    Belgium: 38
    Country: Number of subjects enrolled
    Chile: 58
    Country: Number of subjects enrolled
    France: 38
    Country: Number of subjects enrolled
    South Africa: 68
    Country: Number of subjects enrolled
    Thailand: 32
    Country: Number of subjects enrolled
    United States: 79
    Worldwide total number of subjects
    313
    EEA total number of subjects
    76
    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)
    292
    From 65 to 84 years
    20
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 This study is conducted in two parts. Part A evaluated V116 and the comparator regimen of PCV15 followed by PPSV23. Part B evaluated safety and immunogenicity of PCV15 in participants who received V116 in Part A.

    Period 1
    Period 1 title
    Part A
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V116 + Placebo (Part A), PCV15 (Part B)
    Arm description
    		 Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the 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

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo solution matched to V116 in each 0.5 mL sterile solution

    Investigational medicinal product name
    PCV15
    Investigational medicinal product code
    Other name
    VAXNEUVANCE™
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    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
    		 PCV15 + PPSV23 (Part A)
    Arm description
    		 Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    PPSV23
    Investigational medicinal product code
    Other name
    PNEUMOVAX™23
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 23-valent 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

    Number of subjects in period 1
    		V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Started
    156
    157
    Vaccination 1- V116
    155
    0 [1]
    Vaccination 1- PCV15
    1 [2]
    156
    Vaccination 2- Placebo
    154
    0 [3]
    Vaccination 2-PCV15
    0 [4]
    1 [5]
    Vaccination 2-PPSV23
    0 [6]
    151 [7]
    Completed
    152
    152
    Not completed
    4
    5
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    2
    4
         Lost to follow-up
    1
    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: PCV15 + PPSV23 (Part A) participants could have been considered to complete the study with the receipt of Vaccination 2-PPSV23
    [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: V116 + Placebo (Part A), PCV15 (Part B) group participants, could have been considered to complete the study without the receipt of Vaccination 2-PPSV23.
    [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: PCV15 + PPSV23 (Part A) participants could have been considered to complete the study without the receipt of Vaccination 1- V116.
    [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: One participant in V116 + Placebo (Part A), PCV15 (Part B) group could have been considered to complete the study with the receipt of Vaccination 1- PCV 15.
    [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: Of the 155 participants who received V116 in Part A, 126 participants received PCV15 in Part B. All but 1 participant completed Part B.
    [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: V116 + Placebo (Part A), PCV15 (Part B) group participants, could have been considered to complete the study without the receipt of Vaccination 2-PPSV23.
    [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: V116 + Placebo (Part A), PCV15 (Part B) group participants could have been considered to complete the study without the receipt of vaccination 2- PCV 15.
    Period 2
    Period 2 title
    Part B
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 V116 + Placebo (Part A), PCV15 (Part B)
    Arm description
    		 Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.
    Arm type
    		 Experimental

    Investigational medicinal product name
    V116
    Investigational medicinal product code
    Other name
    Pneumococcal 21-valent Conjugate Vaccine
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the 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

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo solution matched to V116 in each 0.5 mL sterile solution

    Investigational medicinal product name
    PCV15
    Investigational medicinal product code
    Other name
    VAXNEUVANCE™
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    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

    Number of subjects in period 2 [8]
    		V116 + Placebo (Part A), PCV15 (Part B)
    Started
    126
    Completed
    125
    Not completed
    1
         Lost to follow-up
    1
    Notes
    [8] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: One participant in PCV15 + PPSV23 (Part A) group could have been considered to complete the study with the receipt of Vaccination 2- PCV 15.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    V116 + Placebo (Part A), PCV15 (Part B)
    Reporting group description
    		 Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.

    Reporting group title
    PCV15 + PPSV23 (Part A)
    Reporting group description
    		 Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.

    Reporting group values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A) Total
    Number of subjects
    		 156 157 313
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 147 145 292
        From 65-84 years
    		 8 12 20
        85 years and over
    		 1 0 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 44.0 ( 12.6 ) 46.7 ( 12.3 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 42 50 92
        Male
    		 114 107 221
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 1 2
        Asian
    		 21 12 33
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 62 63 125
        White
    		 70 79 149
        More than one race
    		 1 2 3
        Unknown or Not Reported
    		 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 32 44 76
        Not Hispanic or Latino
    		 124 112 236
        Unknown or Not Reported
    		 0 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    V116 + Placebo (Part A), PCV15 (Part B)
    Reporting group description
    		 Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.

    Reporting group title
    PCV15 + PPSV23 (Part A)
    Reporting group description
    		 Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.
    Reporting group title
    V116 + Placebo (Part A), PCV15 (Part B)
    Reporting group description
    		 Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A. In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116.

    Primary: Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A

    		 Close Top of page
    End point title
    		 Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A [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. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.
    End point type
    Primary
    End point timeframe
    Up to 5 days after each vaccination in Part A
    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: V116 + Placebo (Part A), PCV15 (Part B) group participants, could have been considered to complete the study without the receipt of Vaccination 2-PPSV23.
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    155
    155
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site erythema
    3.9 (1.4 to 8.2)
    11.0 (6.5 to 17.0)
        Injection site pain
    50.3 (42.2 to 58.4)
    82.6 (75.7 to 88.2)
        Injection site swelling
    7.1 (3.6 to 12.3)
    20.6 (14.6 to 27.9)
    No statistical analyses for this end point

    Primary: Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination in Part A

    		 Close Top of page
    End point title
    		 Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination in Part A [2]
    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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.
    End point type
    Primary
    End point timeframe
    Up to 5 days after each vaccination in Part A
    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: V116 + Placebo (Part A), PCV15 (Part B) group participants, could have been considered to complete the study without the receipt of Vaccination 2-PPSV23.
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    155
    155
    Units: Percentage of Participants
    number (confidence interval 95%)
        Fatigue
    34.2 (26.8 to 42.2)
    30.3 (23.2 to 38.2)
        Headache
    19.4 (13.5 to 26.5)
    21.9 (15.7 to 29.3)
        Myalgia
    15.5 (10.2 to 22.2)
    12.3 (7.5 to 18.5)
        Pyrexia
    3.2 (1.1 to 7.4)
    1.9 (0.4 to 5.6)
    No statistical analyses for this end point

    Primary: Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in Part A

    		 Close Top of page
    End point title
    		 Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in Part A [3]
    End point description
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. All participants who were randomized and received at least 1 dose of study intervention. Participants were included in the intervention group according to the study intervention actually received. Two participants received the incorrect study intervention that resulted in a regimen inconsistent with the 2 designated regimens planned in this study. Both participants were excluded from the safety analysis population.
    End point type
    Primary
    End point timeframe
    Up to 194 days in Part A
    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: V116 + Placebo (Part A), PCV15 (Part B) group participants, could have been considered to complete the study without the receipt of Vaccination 2-PPSV23.
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    155
    155
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 2.4)
    0.0 (0.0 to 2.4)
    No statistical analyses for this end point

    Primary: Serotype-specific Opsonophagocytic activity (OPA) geometric mean titers (GMT) postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116

    		 Close Top of page
    End point title
    		 Serotype-specific Opsonophagocytic activity (OPA) geometric mean titers (GMT) postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 [4]
    End point description
    Serotype-specific OPA to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to 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. Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
    End point type
    Primary
    End point timeframe
    Up to 114 days
    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: V116 + Placebo (Part A), PCV15 (Part B) group participants, could have been considered to complete the study without the receipt of Vaccination 2-PPSV23.
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    156
    156
    Units: Titers
    geometric mean (confidence interval 95%)
        Serotype 3 (Shared)
    170.7 (132.5 to 220.0)
    172.0 (138.4 to 213.7)
        Serotype 6A (Shared)
    3896.0 (2929.7 to 5181.1)
    3979.5 (3210.6 to 4932.5)
        Serotype 7F (Shared)
    3482.3 (2815.8 to 4306.6)
    3275.6 (2658.1 to 4036.6)
        Serotype 8 (Shared)
    1847.5 (1470.9 to 2320.6)
    2262.9 (1776.5 to 2882.5)
        Serotype 9N (Shared)
    5763.0 (4552.8 to 7294.7)
    5970.0 (4786.9 to 7445.6)
        Serotype 10A (Shared)
    3693.0 (2870.2 to 4751.5)
    3652.8 (2731.4 to 4885.1)
        Serotype 11A (Shared)
    3742.5 (3050.7 to 4591.1)
    1722.3 (1277.1 to 2322.7)
        Serotype 12F (Shared)
    2585.4 (1993.5 to 3353.0)
    2292.4 (1653.2 to 3178.8)
        Serotype 17F (Shared)
    8698.6 (7046.1 to 10738.5)
    5886.3 (4489.8 to 7717.1)
        Serotype 19A (Shared)
    2178.9 (1777.1 to 2671.7)
    2667.0 (2193.2 to 3243.1)
        Serotype 20A (Shared)
    7249.1 (5854.9 to 8975.4)
    5753.3 (4634.0 to 7143.0)
        Serotype 22F (Shared)
    3622.4 (2902.8 to 4520.4)
    3979.8 (3214.5 to 4927.1)
        Serotype 33F (Shared)
    14642.5 (11314.9 to 18948.6)
    11864.5 (9283.8 to 15162.5)
        Serotype 15A (Unique to V116)
    5859.0 (4684.9 to 7327.4)
    1970.5 (1555.1 to 2496.8)
        Serotype 15C (Unique to V116)
    5613.0 (4136.7 to 7616.3)
    2438.0 (1791.5 to 3317.7)
        Serotype 16F (Unique to V116)
    6703.0 (5494.0 to 8178.1)
    1839.0 (1474.3 to 2293.9)
        Serotype 23A (Unique to V116)
    5053.5 (3781.3 to 6753.5)
    1674.9 (1209.9 to 2318.7)
        Serotype 23B (Unique to V116)
    1593.8 (1182.7 to 2147.9)
    151.0 (98.1 to 232.6)
        Serotype 24B (Unique to V116)
    3725.6 (3161.1 to 4391.0)
    567.9 (375.4 to 859.1)
        Serotype 31 (Unique to V116)
    5699.4 (4435.1 to 7324.2)
    530.8 (364.2 to 773.7)
        Serotype 35B (Unique to V116)
    11306.2 (9364.7 to 13650.1)
    2977.7 (2425.5 to 3655.8)
    No statistical analyses for this end point

    Secondary: Serotype-specific Immunoglobulin G (IgG) geometric mean concentration (GMC) postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116

    		 Close Top of page
    End point title
    		 Serotype-specific Immunoglobulin G (IgG) geometric mean concentration (GMC) postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
    End point type
    Secondary
    End point timeframe
    Up to 114 days
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    156
    156
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 3 (Shared)
    0.50 (0.43 to 0.59)
    0.58 (0.49 to 0.67)
        Serotype 6A (Shared)
    3.79 (2.77 to 5.18)
    2.80 (2.02 to 3.89)
        Serotype 7F (Shared)
    2.95 (2.31 to 3.77)
    1.81 (1.49 to 2.21)
        Serotype 8 (Shared)
    7.05 (5.76 to 8.64)
    8.10 (6.66 to 9.85)
        Serotype 9N (Shared)
    5.02 (4.01 to 6.28)
    3.36 (2.73 to 4.14)
        Serotype 10A (Shared)
    7.15 (5.24 to 9.75)
    3.73 (2.78 to 5.00)
        Serotype 11A (Shared)
    4.40 (3.55 to 5.45)
    2.64 (2.13 to 3.27)
        Serotype 12F (Shared)
    1.10 (0.83 to 1.47)
    0.71 (0.51 to 0.99)
        Serotype 17F (Shared)
    10.34 (8.24 to 12.96)
    4.43 (3.49 to 5.61)
        Serotype 19A (Shared)
    5.96 (4.88 to 7.30)
    5.99 (4.83 to 7.43)
        Serotype 20A (Shared)
    7.08 (5.60 to 8.95)
    4.94 (3.81 to 6.41)
        Serotype 22F (Shared)
    3.70 (2.96 to 4.61)
    2.99 (2.40 to 3.72)
        Serotype 33F (Shared)
    7.55 (5.90 to 9.65)
    5.56 (4.41 to 7.01)
        Serotype 15A (Unique to V116)
    5.67 (4.37 to 7.36)
    1.02 (0.80 to 1.31)
        Serotype 15C (Unique to V116)
    6.92 (5.15 to 9.29)
    2.68 (2.07 to 3.49)
        Serotype 16F (Unique to V116)
    1.55 (1.23 to 1.95)
    0.21 (0.16 to 0.26)
        Serotype 23F (Unique to V116)
    2.54 (1.85 to 3.50)
    0.41 (0.30 to 0.55)
        Serotype 23B (Unique to V116)
    3.27 (2.51 to 4.25)
    0.99 (0.75 to 1.31)
        Serotype 24F (Unique to V116)
    1.80 (1.25 to 2.59)
    0.17 (0.13 to 0.21)
        Serotype 31 (Unique to V116)
    2.20 (1.78 to 2.72)
    0.25 (0.20 to 0.31)
        Serotype 35B (Unique to V116)
    10.26 (7.96 to 13.22)
    0.90 (0.73 to 1.10)
    No statistical analyses for this end point

    Secondary: Serotype-specific OPA geometric mean fold rises (GMFRs) postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116

    		 Close Top of page
    End point title
    		 Serotype-specific OPA geometric mean fold rises (GMFRs) postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
    End point description
    Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using a Multiplexed Opsonophagocytic Assay (MOPA). Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23. Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    156
    156
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 3 (Shared)
    5.5 (4.3 to 7.1)
    5.3 (4.3 to 6.7)
        Serotype 6A (Shared)
    14.3 (10.3 to 19.9)
    15.3 (11.3 to 20.7)
        Serotype 7F (Shared)
    12.3 (9.1 to 16.3)
    7.4 (5.4 to 10.3)
        Serotype 8 (Shared)
    11.9 (8.6 to 16.3)
    15.0 (10.4 to 21.8)
        Serotype 9N (Shared)
    6.7 (5.0 to 8.9)
    5.9 (4.5 to 7.7)
        Serotype 10A (Shared)
    9.4 (7.1 to 12.6)
    7.4 (5.4 to 10.2)
        Serotype 11A (Shared)
    9.2 (6.4 to 13.4)
    3.8 (2.7 to 5.3)
        Serotype 12F (Shared)
    57.3 (42.0 to 78.0)
    46.7 (31.4 to 69.4)
        Serotype 17F (Shared)
    15.1 (11.2 to 20.2)
    8.5 (6.4 to 11.5)
        Serotype 19A (Shared)
    5.0 (3.9 to 6.3)
    5.6 (4.4 to 7.2)
        Serotype 20A (Shared)
    7.1 (5.5 to 9.2)
    4.7 (3.7 to 6.0)
        Serotype 22F(Shared)
    19.2 (13.2 to 28.1)
    19.3 (12.7 to 29.4)
        Serotype 33F (Shared)
    7.5 (5.6 to 10.1)
    6.8 (5.2 to 9.1)
        Serotype 15A (Unique to V116)
    5.7 (4.2 to 7.7)
    1.4 (1.1 to 1.8)
        Serotype 15C (Unique to V116)
    27.8 (18.7 to 41.4)
    16.3 (10.9 to 24.3)
        Serotype 16F (Unique to V116)
    6.3 (4.8 to 8.2)
    1.7 (1.4 to 2.0)
        Serotype 23A (Unique to V116)
    9.0 (6.0 to 13.7)
    2.8 (1.7 to 4.8)
        Serotype 23B (Unique to V116)
    52.0 (35.7 to 75.6)
    7.2 (4.9 to 10.4)
        Serotype 24F (Unique to V116)
    5.8 (4.0 to 8.3)
    1.0 (0.8 to 1.3)
        Serotype 31 (Unique to V116)
    19.9 (13.8 to 28.6)
    1.5 (1.1 to 2.0)
        Serotype 35B (Unique to V116)
    5.4 (4.3 to 6.8)
    1.3 (1.1 to 1.5)
    No statistical analyses for this end point

    Secondary: Serotype-specific IgG GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116

    		 Close Top of page
    End point title
    		 Serotype-specific IgG GMFRs postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination with V116 and PCV15 + PPSV23. Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    156
    156
    Units: Ratio
    geometric mean (confidence interval 95%)
        Serotype 3 (Shared)
    3.7 (3.2 to 4.3)
    4.0 (3.4 to 4.6)
        Serotype 6A (Shared)
    11.4 (8.8 to 14.6)
    9.2 (7.1 to 11.8)
        Serotype 7F (Shared)
    9.1 (7.3 to 11.3)
    5.7 (4.7 to 6.8)
        Serotype 8 (Shared)
    8.1 (6.5 to 10.1)
    10.0 (7.9 to 12.8)
        Serotype 9N (Shared)
    10.4 (8.3 to 13.0)
    7.8 (6.3 to 9.6)
        Serotype 10A (Shared)
    12.2 (9.7 to 15.3)
    8.2 (6.7 to 10.0)
        Serotype 11A (Shared)
    6.6 (5.5 to 7.9)
    4.5 (3.8 to 5.3)
        Serotype 12F (Shared)
    9.7 (7.7 to 12.4)
    6.7 (5.1 to 8.8)
        Serotype 17F (Shared)
    13.8 (11.1 to 17.1)
    7.5 (6.2 to 9.1)
        Serotype 19A (Shared)
    3.8 (3.2 to 4.6)
    4.8 (4.1 to 5.6)
        Serotype 20A (Shared)
    7.3 (6.0 to 8.9)
    5.4 (4.5 to 6.5)
        Serotype 22F (Shared)
    13.7 (10.7 to 17.5)
    10.4 (8.4 to 13.0)
        Serotype 33F (Shared)
    8.1 (6.6 to 10.0)
    5.9 (4.9 to 7.1)
        Serotype 15A (unique to V116)
    16.1 (13.1 to 19.9)
    2.4 (2.1 to 2.8)
        Serotype 15C (unique to V116)
    16.6 (13.3 to 20.8)
    6.1 (5.0 to 7.5)
        Serotype 16F (unique to V116)
    8.8 (7.3 to 10.7)
    1.4 (1.3 to 1.6)
        Serotype 23A (unique to V116)
    15.8 (12.3 to 20.3)
    2.8 (2.3 to 3.4)
        Serotype 23B (unique to V116)
    10.0 (8.0 to 12.6)
    3.6 (2.9 to 4.4)
        Serotype 24F (unique to V116)
    10.9 (8.3 to 14.2)
    1.0 (0.9 to 1.1)
        Serotype 31 (unique to V116)
    11.6 (9.6 to 14.0)
    1.4 (1.3 to 1.6)
        Serotype 35B (unique to V116)
    11.8 (9.4 to 14.7)
    1.1 (1.0 to 1.1)
    No statistical analyses for this end point

    Secondary: Percentage of participants with a >=4-fold rise in OPA responses from baseline (Day 1) to postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116

    		 Close Top of page
    End point title
    		 Percentage of participants with a >=4-fold rise in OPA responses from baseline (Day 1) to postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
    End point description
    Activity for the serotypes contained in V116 and PCV15+PPSV23 (13 serotypes shared with PCV15 and PPSV23 and 8 serotypes unique to V116) was determined using MOPA. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination with V116 and PCV15 + PPSV23. Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    156
    156
    Units: Percentage of Participants
    number (confidence interval 95%)
        Serotype 3 (Shared)
    58.7 (49.4 to 67.6)
    61.9 (52.5 to 70.6)
        Serotype 6A (Shared)
    73.8 (65.0 to 81.3)
    80.2 (71.7 to 87.0)
        Serotype 7F (Shared)
    69.0 (60.3 to 76.8)
    59.2 (49.8 to 68.0)
        Serotype 8 (Shared)
    66.9 (58.3 to 74.7)
    70.1 (61.3 to 77.9)
        Serotype 9N (Shared)
    56.3 (47.2 to 65.2)
    57.7 (48.5 to 66.6)
        Serotype 10A (Shared)
    62.2 (53.2 to 70.7)
    60.5 (50.9 to 69.6)
        Serotype 11A (Shared)
    53.6 (44.5 to 62.6)
    43.6 (34.4 to 53.1)
        Serotype 12F (Shared)
    92.2 (86.1 to 96.2)
    83.3 (75.4 to 89.5)
        Serotype 17F (Shared)
    77.1 (68.9 to 84.0)
    64.7 (55.4 to 73.2)
        Serotype 19A (Shared)
    49.2 (40.4 to 58.1)
    55.9 (46.8 to 64.7)
        Serotype 20A (Shared)
    59.2 (50.3 to 67.8)
    49.2 (40.1 to 58.3)
        Serotype 22F (Shared)
    76.0 (67.4 to 83.3)
    71.7 (62.4 to 79.8)
        Serotype 33F (Shared)
    61.9 (52.3 to 70.9)
    58.8 (49.4 to 67.8)
        Serotype 15A (Unique to V116)
    59.3 (49.4 to 68.6)
    21.1 (14.0 to 29.7)
        Serotype 16F (Unique to V116)
    53.6 (44.5 to 62.6)
    16.8 (10.6 to 24.8)
        Serotype 23A (Unique to V116)
    57.9 (47.3 to 68.0)
    32.5 (22.2 to 44.1)
        Serotype 23B (Unique to V116)
    87.0 (79.7 to 92.4)
    50.0 (40.7 to 59.3)
        Serotype 24F (Unique to V116)
    53.8 (43.1 to 64.4)
    7.2 (2.4 to 16.1)
        Serotype 31 (Unique to V116)
    73.7 (65.3 to 80.9)
    16.5 (10.4 to 24.4)
        Serotype 35B (Unique to V116)
    55.6 (46.8 to 64.2)
    5.6 (2.3 to 11.2)
        Serotype 15C (Unique to V116)
    80.4 (71.8 to 87.3)
    71.0 (61.5 to 79.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants with a >=4-fold rise in IgG responses from baseline (Day 1) to postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116

    		 Close Top of page
    End point title
    		 Percentage of participants with a >=4-fold rise in IgG responses from baseline (Day 1) to postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
    End point description
    The GMC of IgG serotype-specific antibodies to the 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116 were quantitated from participants' sera by a multiplex ECL assay. The percentage of participants who had ≥4-fold rise in IgG concentration was calculated from baseline to postvaccination with V116 and PCV15 + PPSV23. Overall participants analyzed included all randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses. The number analyzed for each serotype is the subset of overall participants analyzed without protocol deviation such as failure to receive study vaccine, failure to receive correct clinical material as per randomization schedule, or receipt of a prohibited medication or prohibited vaccine prior to study vaccination.
    End point type
    Secondary
    End point timeframe
    Baseline, 30 days post vaccination day 1 (V116), and 30 days post vaccination week 8 (PCV15 + PPSV23)
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Number of subjects analysed
    156
    156
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 3 (Shared)
    42.3 (33.9 to 51.1)
    50.4 (41.6 to 59.2)
        Serotype 6A (Shared)
    70.8 (62.4 to 78.3)
    68.2 (59.5 to 76.0)
        Serotype 7F (Shared)
    70.1 (61.7 to 77.6)
    57.9 (49.0 to 66.4)
        Serotype 8 (Shared)
    66.4 (57.9 to 74.3)
    73.7 (65.3 to 80.9)
        Serotype 9N (Shared)
    75.2 (67.1 to 82.2)
    67.7 (59.0 to 75.5)
        Serotype 10A (Shared)
    76.6 (68.7 to 83.4)
    68.4 (59.8 to 76.2)
        Serotype 11A (Shared)
    66.4 (57.9 to 74.3)
    54.1 (45.3 to 62.8)
        Serotype 12F (Shared)
    67.9 (59.4 to 75.6)
    60.2 (51.3 to 68.5)
        Serotype 17F (Shared)
    83.9 (76.7 to 89.7)
    73.7 (65.3 to 80.9)
        Serotype 19A (Shared)
    43.8 (35.3 to 52.5)
    58.6 (49.8 to 67.1)
        Serotype 20A (Shared)
    67.2 (58.6 to 74.9)
    57.1 (48.3 to 65.7)
        Serotype 22F (Shared)
    76.6 (68.7 to 83.4)
    78.9 (71.0 to 85.5)
        Serotype 33F (Shared)
    67.9 (59.4 to 75.6)
    63.2 (54.4 to 71.4)
        Serotype 15A (Unique to V116)
    83.9 (76.7 to 89.7)
    21.8 (15.1 to 29.8)
        Serotype 15C (Unique to V116)
    82.5 (75.1 to 88.4)
    61.7 (52.8 to 69.9)
        Serotype 16F (Unique to V116)
    73.7 (65.5 to 80.9)
    9.0 (4.7 to 15.2)
        Serotype 23A (Unique to V116)
    82.5 (75.1 to 88.4)
    29.3 (21.8 to 37.8)
        Serotype 23B (Unique to V116)
    72.3 (64.0 to 79.6)
    37.6 (29.3 to 46.4)
        Serotype 24F (Unique to V116)
    70.1 (61.7 to 77.6)
    0.0 (0.0 to 2.7)
        Serotype 31 (Unique to V116)
    83.2 (75.9 to 89.0)
    6.8 (3.1 to 12.5)
        Serotype 35B (Unique to V116)
    75.9 (67.9 to 82.8)
    0.8 (0.0 to 4.1)
    No statistical analyses for this end point

    Secondary: Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B

    		 Close Top of page
    End point title
    		 Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B
    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. The percentage of participants with solicited systemic AEs was assessed following any vaccination. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. Percentage of participants with solicited systemic AEs from Day 1 of Part B through Day 5 postvaccination in Part B. All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after vaccination in Part B
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B)
    Number of subjects analysed
    126
    Units: Percentage of Participants
    number (confidence interval 95%)
        Fatigue
    22.2 (15.3 to 30.5)
        Headache
    14.3 (8.7 to 21.6)
        Myalgia
    11.1 (6.2 to 17.9)
        Pyrexia
    0.8 (0.0 to 4.3)
    No statistical analyses for this end point

    Secondary: Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B

    		 Close Top of page
    End point title
    		 Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B
    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. The percentage of participants with solicited injection-site AEs after any vaccination was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain. Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B. All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
    End point type
    Secondary
    End point timeframe
    Up to 5 days after vaccination in Part B
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B)
    Number of subjects analysed
    126
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site erythema
    3.2 (0.9 to 7.9)
        Injection site pain
    61.9 (52.8 to 70.4)
        Injection site swelling
    6.3 (2.8 to 12.1)
    No statistical analyses for this end point

    Secondary: Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B

    		 Close Top of page
    End point title
    		 Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B
    End point description
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following any vaccination, the percentage of serious adverse events was assessed. Percentage of participants with vaccine-related SAEs from Day 1 of Part B through the duration of participation in Part B. All participants who were randomized and received at least 1 dose of study intervention in part B. Participants were included in the intervention group according to the study intervention actually received.
    End point type
    Secondary
    End point timeframe
    Up to 44 days after vaccination in Part B
    End point values
    		 V116 + Placebo (Part A), PCV15 (Part B)
    Number of subjects analysed
    126
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.0 (0.0 to 2.9)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Part A - Non-serious adverse events (NSAEs): Up to 30 days after each vaccination; SAEs and ACM: Up to 194 days after the first vaccination. Part B - NSAEs: Up to 30 days after vaccination; SAEs and ACM: Up to 44 days after vaccination.
    Adverse event reporting additional description
    The ACM, SAE and AE population includes all randomized participants. Two participants received incorrect study intervention that resulted in a regimen inconsistent with the 2 planned regimens. Both participants were excluded from the safety analysis population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    V116 + Placebo (Part A)
    Reporting group description
    		 Participants received a single intramuscular (IM) dose of V116 on Day 1 and a single IM dose of placebo on Week 8 in Part A.

    Reporting group title
    V116 + Placebo (Part A), PCV15 (Part B)
    Reporting group description
    		 In Part B, a single IM dose of PCV15 was given approximately between 10 to 18 months after V116 in participant who received V116 in Part A.

    Reporting group title
    PCV15 + PPSV23 (Part A)
    Reporting group description
    		 Participants received a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8 in Part A of the study.

    Serious adverse events
    		 V116 + Placebo (Part A) V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 155 (2.58%)
    1 / 126 (0.79%)
    6 / 155 (3.87%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to meninges
         subjects affected / exposed
    0 / 155 (0.00%)
    0 / 126 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 155 (0.00%)
    0 / 126 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 126 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 126 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 126 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 155 (0.00%)
    0 / 126 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 155 (0.00%)
    1 / 126 (0.79%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 126 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 155 (0.65%)
    0 / 126 (0.00%)
    0 / 155 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 155 (0.00%)
    0 / 126 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    0 / 155 (0.00%)
    0 / 126 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 155 (0.00%)
    0 / 126 (0.00%)
    1 / 155 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V116 + Placebo (Part A) V116 + Placebo (Part A), PCV15 (Part B) PCV15 + PPSV23 (Part A)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    96 / 155 (61.94%)
    82 / 126 (65.08%)
    136 / 155 (87.74%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    38 / 155 (24.52%)
    19 / 126 (15.08%)
    31 / 155 (20.00%)
         occurrences all number
    48
    20
    35
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    6 / 155 (3.87%)
    4 / 126 (3.17%)
    17 / 155 (10.97%)
         occurrences all number
    8
    4
    19
    Fatigue
         subjects affected / exposed
    47 / 155 (30.32%)
    28 / 126 (22.22%)
    53 / 155 (34.19%)
         occurrences all number
    56
    28
    68
    Injection site pain
         subjects affected / exposed
    78 / 155 (50.32%)
    78 / 126 (61.90%)
    128 / 155 (82.58%)
         occurrences all number
    93
    78
    199
    Injection site swelling
         subjects affected / exposed
    11 / 155 (7.10%)
    8 / 126 (6.35%)
    32 / 155 (20.65%)
         occurrences all number
    13
    8
    36
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 155 (1.29%)
    1 / 126 (0.79%)
    9 / 155 (5.81%)
         occurrences all number
    2
    1
    9
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    20 / 155 (12.90%)
    14 / 126 (11.11%)
    24 / 155 (15.48%)
         occurrences all number
    22
    14
    29

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Jun 07 00:02:37 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA