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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Children Infected with Human Immunodeficiency Virus (HIV) (PNEU-WAY PED)

    Summary
    EudraCT number
    		 2019-000341-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2021
    First version publication date
    28 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V114-030
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03921424
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002215-PIP01-17
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 May 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 May 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a study of V114 in children infected with HIV. Participants were randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of PNEUMOVAX™23. The primary objectives of this study were to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13™ by each vaccination group. There were no formal hypotheses.
    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
    05 Nov 2019
    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
    Thailand: 127
    Country: Number of subjects enrolled
    South Africa: 191
    Country: Number of subjects enrolled
    Ukraine: 89
    Worldwide total number of subjects
    407
    EEA total number of subjects
    0
    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)
    122
    Adolescents (12-17 years)
    285
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study recruited 6-17 year old participants with HIV.

    Pre-assignment
    Screening details
    		 407 participants were randomized in a 1:1 ratio to receive either V114 or Prevnar 13™ on Day 1 and PNEUMOVAX™23 at Week 8.

    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
    Study was double-blinded with in-house blinding procedures.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 V114
    Arm description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PNEUMOVAX™23
    Investigational medicinal product code
    Other name
    23-valent pneumococcal polysaccharide vaccine (PPV23)
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

    Investigational medicinal product name
    V114
    Investigational medicinal product code
    Other name
    Pneumococcal 15-valent Conjugate Vaccine, VAXNEUVANCE™
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose

    Arm title
    		 Prevnar 13™
    Arm description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevnar 13™
    Investigational medicinal product code
    Other name
    13-valent pneumococcal conjugate vaccine (PCV13)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose

    Investigational medicinal product name
    PNEUMOVAX™23
    Investigational medicinal product code
    Other name
    PPV23
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

    Number of subjects in period 1
    		V114 Prevnar 13™
    Started
    203
    204
    Vaccination 1 - (Day 1)
    203
    204
    Vaccination 2 - (Week 8)
    203
    202
    Completed
    203
    201
    Not completed
    0
    3
         Withdrawal By Parent/Guardian
    -
    2
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Reporting group values
    		 V114 Prevnar 13™ Total
    Number of subjects
    		 203 204 407
    Age Categorical
    Units: Participants
        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)
    		 60 62 122
        Adolescents (12-17 years)
    		 143 142 285
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 12.7 ± 2.7 12.6 ± 3.0 -
    Gender Categorical
    Units: Participants
        Male
    		 107 105 212
        Female
    		 96 99 195
    Race
    Units: Subjects
        Asian
    		 62 66 128
        Black Or African American
    		 88 78 166
        Multiple
    		 12 9 21
        White
    		 40 49 89
        Missing
    		 1 2 3
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    		 0 1 1
        Not Hispanic Or Latino
    		 201 203 404
        Not Reported
    		 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Primary: Percentage of Participants with a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™

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    End point title
    		 Percentage of Participants with a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ [1]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Through 14 Days after Vaccination 1 (Up to Day 14)
    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 comparisons were performed for this end point.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    204
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site redness/erythema
    9.4 (5.7 to 14.2)
    5.9 (3.1 to 10.0)
        Injection site hard lump/induration
    10.3 (6.5 to 15.4)
    6.4 (3.4 to 10.7)
        Injection site tenderness/pain
    55.2 (48.1 to 62.1)
    53.9 (46.8 to 60.9)
        Injection site swelling
    28.6 (22.5 to 35.3)
    21.6 (16.1 to 27.9)
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™

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    End point title
    		 Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ [2]
    End point description
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. All randomized participants who received at least 1 dose of study vaccination were analyzed.
    End point type
    Primary
    End point timeframe
    Through 14 Days after Vaccination 1 (Up to Day 14)
    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 comparisons were performed for this end point.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    204
    Units: Percentage of Participants
    number (confidence interval 95%)
        Joint pain/arthralgia
    9.4 (5.7 to 14.2)
    10.3 (6.5 to 15.3)
        Tiredness/fatigue
    7.9 (4.6 to 12.5)
    8.3 (4.9 to 13.0)
        Headache
    14.8 (10.2 to 20.4)
    10.8 (6.9 to 15.9)
        Muscle pain/myalgia
    34.0 (27.5 to 41.0)
    25.5 (19.7 to 32.0)
        Hives or welts/urticaria
    0.5 (0.0 to 2.7)
    1.5 (0.3 to 4.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study

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    End point title
    		 Percentage of Participants with a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study [3]
    End point description
    An SAE is an AE that results in death, 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. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) through completion of study participation was reported. All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not analyzed for Vaccination 2.
    End point type
    Primary
    End point timeframe
    Through 6 Months after Vaccination 1 (Up to Day 194)
    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 comparisons were performed for this end point.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    204
    Units: Percentage of Participants
    number (confidence interval 95%)
        Vaccination 1 (n = 203, 204)
    0.0 (0.0 to 1.8)
    0.0 (0.0 to 1.8)
        Vaccination 2 (n = 203, 202)
    0.0 (0.0 to 1.8)
    0.0 (0.0 to 1.8)
    No statistical analyses for this end point

    Primary: Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™

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    End point title
    		 Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ [4]
    End point description
    The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. 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
    Day 30
    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 comparisons were performed for this end point.
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    204
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=194, 196)
    2.17 (1.89 to 2.48)
    3.26 (2.82 to 3.77)
        Serotype 3 (Shared) (n=194, 196)
    1.05 (0.93 to 1.19)
    0.84 (0.73 to 0.97)
        Serotype 4 (Shared) (n=194, 196)
    2.59 (2.23 to 3.00)
    4.27 (3.57 to 5.11)
        Serotype 5 (Shared) (n=194, 196)
    2.94 (2.44 to 3.54)
    2.78 (2.30 to 3.37)
        Serotype 6A (Shared) (n=194, 196)
    7.98 (6.30 to 10.11)
    7.56 (6.06 to 9.45)
        Serotype 6B (Shared) (n=194, 196)
    11.44 (9.07 to 14.43)
    6.92 (5.45 to 8.79)
        Serotype 7F (Shared) (n=194, 196)
    4.84 (4.10 to 5.71)
    5.00 (4.29 to 5.83)
        Serotype 9V (Shared) (n=194, 196)
    4.15 (3.56 to 4.85)
    4.78 (4.03 to 5.66)
        Serotype 14 (Shared) (n=194, 196)
    20.38 (16.39 to 25.35)
    18.29 (14.43 to 23.17)
        Serotype 18C (Shared) (n=194, 196)
    5.18 (4.32 to 6.20)
    5.15 (4.29 to 6.18)
        Serotype 19A (Shared) (n=194, 196)
    14.20 (11.81 to 17.07)
    14.78 (12.45 to 17.54)
        Serotype 19F (Shared) (n=194, 196)
    9.76 (8.03 to 11.85)
    8.61 (7.28 to 10.18)
        Serotype 23F (Shared) (n=194, 196)
    6.71 (5.42 to 8.31)
    6.35 (5.14 to 7.85)
        Serotype 22F (Unique to V114) (n=194, 193)
    9.28 (7.76 to 11.09)
    0.24 (0.20 to 0.29)
        Serotype 33F (Unique to V114) (n=194, 196)
    4.53 (3.80 to 5.39)
    0.29 (0.25 to 0.33)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23

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    End point title
    		 Percentage of Participants with a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
    End point description
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling. All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Through 14 Days after Vaccination 2 (Up to Day 84)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    202
    Units: Percentage of Participants
    number (confidence interval 95%)
        Injection site redness/erythema
    10.3 (6.5 to 15.4)
    12.4 (8.2 to 17.7)
        Injection site hard lump/induration
    18.2 (13.2 to 24.2)
    13.4 (9.0 to 18.8)
        Injection site tenderness/pain
    51.7 (44.6 to 58.8)
    55.0 (47.8 to 61.9)
        Injection site swelling
    47.3 (40.3 to 54.4)
    34.7 (28.1 to 41.7)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23

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    End point title
    		 Percentage of Participants with a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
    End point description
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria. All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Through 14 Days after Vaccination 2 (Up to Day 84)
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    202
    Units: Percentage of Participants
    number (confidence interval 95%)
        Joint pain/arthralgia
    12.8 (8.5 to 18.2)
    8.4 (5.0 to 13.1)
        Tiredness/fatigue
    12.3 (8.1 to 17.6)
    11.4 (7.4 to 16.6)
        Headache
    10.3 (6.5 to 15.4)
    9.4 (5.8 to 14.3)
        Muscle pain/myalgia
    43.3 (36.4 to 50.5)
    39.1 (32.3 to 46.2)
        Hives or welts/urticaria
    0.0 (0.0 to 1.8)
    0.5 (0.0 to 2.7)
    No statistical analyses for this end point

    Secondary: Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™

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    End point title
    		 Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
    End point description
    The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. 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 30
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    204
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=164, 160)
    353.4 (278.4 to 448.7)
    398.3 (313.5 to 506.1)
        Serotype 3 (Shared) (n=163, 158)
    330.0 (284.4 to 383.0)
    301.5 (255.5 to 355.7)
        Serotype 4 (Shared) (n=164, 159)
    6078.3 (5106.1 to 7235.4)
    9172.8 (7582.8 to 11096.1)
        Serotype 5 (Shared) (n=164, 160)
    847.6 (671.1 to 1070.4)
    642.1 (490.9 to 839.9)
        Serotype 6A (Shared) (n=163, 159)
    14274.6 (12014.1 to 16960.4)
    11915.4 (10160.9 to 13973.0)
        Serotype 6B (Shared) (n=164, 160)
    17636.5 (14728.7 to 21118.3)
    15052.9 (12719.6 to 17814.2)
        Serotype 7F (Shared) (n=164, 160)
    17574.4 (15234.2 to 20274.0)
    18519.3 (16010.9 to 21420.8)
        Serotype 9V (Shared) (n=164, 160)
    4800.0 (4201.0 to 5484.4)
    5879.7 (4853.9 to 7122.2)
        Serotype 14 (Shared) (n=164, 160)
    18444.3 (15257.3 to 22297.0)
    17920.8 (14874.4 to 21591.2)
        Serotype 18C (Shared) (n=163, 160)
    4556.2 (3794.1 to 5471.5)
    3543.0 (2919.6 to 4299.5)
        Serotype 19A (Shared) (n=164, 160)
    8176.4 (6778.3 to 9862.8)
    8690.2 (7382.3 to 10229.8)
        Serotype 19F (Shared) (n=164, 159)
    3711.8 (3178.0 to 4335.2)
    3277.6 (2833.1 to 3791.8)
        Serotype 23F (Shared) (n=162, 160)
    11693.1 (9483.8 to 14417.1)
    11933.8 (9597.5 to 14838.8)
        Serotype 22F (Unique to V114) (n=164, 142)
    10791.3 (9157.2 to 12716.9)
    503.1 (330.1 to 766.8)
        Serotype 33F (Unique to V114) (n=162, 159)
    36357.0 (31146.2 to 42439.6)
    5520.6 (4659.5 to 6540.9)
    No statistical analyses for this end point

    Secondary: Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23

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    End point title
    		 Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23
    End point description
    The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. 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. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    202
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=164, 162)
    326.4 (267.0 to 399.0)
    337.0 (272.3 to 417.1)
        Serotype 3 (Shared) (n=164, 161)
    327.2 (278.9 to 383.9)
    384.8 (333.0 to 444.6)
        Serotype 4 (Shared) (n=164, 162)
    5445.7 (4663.7 to 6358.8)
    7526.8 (6309.7 to 8978.7)
        Serotype 5 (Shared) (n=165, 162)
    985.6 (813.6 to 1193.8)
    939.5 (737.3 to 1197.3)
        Serotype 6A (Shared) (n=164, 162)
    10208.7 (8703.8 to 11973.7)
    10699.8 (9010.5 to 12705.7)
        Serotype 6B (Shared) (n=164, 162)
    13774.8 (11661.6 to 16271.0)
    12745.8 (10887.3 to 14921.6)
        Serotype 7F (Shared) (n=165, 162)
    17415.9 (15091.4 to 20098.5)
    19140.5 (16778.5 to 21835.0)
        Serotype 9V (Shared) (n=165, 161)
    5135.9 (4328.2 to 6094.3)
    6152.2 (5219.6 to 7251.4)
        Serotype 14 (Shared) (n=165, 161)
    17207.5 (14074.5 to 21037.9)
    16461.2 (13695.1 to 19785.9)
        Serotype 18C (Shared) (n=165, 161)
    3635.1 (3103.0 to 4258.5)
    3369.0 (2844.0 to 3990.9)
        Serotype 19A (Shared) (n=164, 162)
    7613.7 (6414.6 to 9036.9)
    8838.0 (7592.6 to 10287.6)
        Serotype 19F (Shared) (n=165, 162)
    3694.8 (3212.9 to 4248.9)
    3904.4 (3382.3 to 4507.1)
        Serotype 23F (Shared) (n=163, 161)
    10216.7 (8465.7 to 12329.8)
    10086.0 (8334.0 to 12206.2)
        Serotype 22F (Unique to V114) (n=165, 162)
    8756.1 (7419.0 to 10334.1)
    6958.0 (5941.5 to 8148.5)
        Serotype 33F (Unique to V114) (n=163, 162)
    34173.6 (29554.9 to 39514.0)
    30651.0 (26240.5 to 35802.8)
    No statistical analyses for this end point

    Secondary: Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23

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    End point title
    		 Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23
    End point description
    The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. 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. Two participants in the Prevnar 13™ group did not receive PNEUMOVAX™23 and therefore were not included in the analysis for this end point.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 V114 Prevnar 13™
    Number of subjects analysed
    203
    202
    Units: μg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 (Shared) (n=192, 183)
    2.58 (2.31 to 2.88)
    3.33 (2.95 to 3.75)
        Serotype 3 (Shared) (n=192, 183)
    1.10 (0.97 to 1.24)
    1.08 (0.94 to 1.24)
        Serotype 4 (Shared) (n=192, 182)
    2.36 (2.08 to 2.69)
    3.61 (3.09 to 4.23)
        Serotype 5 (Shared) (n=192, 183)
    3.01 (2.58 to 3.52)
    3.24 (2.75 to 3.82)
        Serotype 6A (Shared) (n=192, 183)
    4.67 (3.74 to 5.84)
    4.91 (3.94 to 6.11)
        Serotype 6B (Shared) (n=192, 183)
    7.12 (5.75 to 8.81)
    4.96 (3.96 to 6.22)
        Serotype 7F (Shared) (n=192, 183)
    4.10 (3.55 to 4.72)
    4.27 (3.71 to 4.92)
        Serotype 9V (Shared) (n=192, 183)
    3.69 (3.20 to 4.25)
    4.52 (3.89 to 5.24)
        Serotype 14 (Shared) (n=192, 183)
    18.88 (15.43 to 23.09)
    19.89 (16.00 to 24.72)
        Serotype 18C (Shared) (n=192, 183)
    3.75 (3.18 to 4.43)
    4.11 (3.48 to 4.85)
        Serotype 19A (Shared) (n=192, 183)
    11.23 (9.48 to 13.31)
    12.19 (10.38 to 14.32)
        Serotype 19F (Shared) (n=192, 183)
    8.56 (7.26 to 10.08)
    7.98 (6.83 to 9.33)
        Serotype 23F (Shared) (n=192, 183)
    4.40 (3.63 to 5.34)
    4.83 (3.96 to 5.88)
        Serotype 22F (Unique to V114) (n=192, 183)
    8.18 (7.10 to 9.42)
    10.32 (8.67 to 12.29)
        Serotype 33F (Unique to V114) (n=192, 183)
    3.76 (3.23 to 4.38)
    6.18 (5.23 to 7.30)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and deaths (all-causes): Through 6 months after Vaccination 1 (Up to Day 194).
    Adverse event reporting additional description
    The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination. All randomized participants received treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    V114
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Reporting group title
    Prevnar 13™
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Reporting group title
    V114 (Post-PNEUMOVAX™23)
    Reporting group description
    		 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Reporting group title
    Prevnar 13™ (Post-PNEUMOVAX™23)
    Reporting group description
    		 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and were to receive a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2).

    Serious adverse events
    		 V114 Prevnar 13™ V114 (Post-PNEUMOVAX™23) Prevnar 13™ (Post-PNEUMOVAX™23)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 203 (0.49%)
    1 / 204 (0.49%)
    2 / 203 (0.99%)
    2 / 202 (0.99%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hodgkin's disease
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 204 (0.00%)
    1 / 203 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Serous retinal detachment
         subjects affected / exposed
    0 / 203 (0.00%)
    1 / 204 (0.49%)
    0 / 203 (0.00%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 204 (0.00%)
    1 / 203 (0.49%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Abnormal uterine bleeding
         subjects affected / exposed
    1 / 203 (0.49%)
    0 / 204 (0.00%)
    0 / 203 (0.00%)
    0 / 202 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 204 (0.00%)
    0 / 203 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diarrhoea infectious
         subjects affected / exposed
    0 / 203 (0.00%)
    0 / 204 (0.00%)
    0 / 203 (0.00%)
    1 / 202 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 V114 Prevnar 13™ V114 (Post-PNEUMOVAX™23) Prevnar 13™ (Post-PNEUMOVAX™23)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    158 / 203 (77.83%)
    138 / 204 (67.65%)
    152 / 203 (74.88%)
    154 / 202 (76.24%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    30 / 203 (14.78%)
    22 / 204 (10.78%)
    21 / 203 (10.34%)
    19 / 202 (9.41%)
         occurrences all number
    34
    28
    25
    22
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    16 / 203 (7.88%)
    17 / 204 (8.33%)
    25 / 203 (12.32%)
    23 / 202 (11.39%)
         occurrences all number
    16
    19
    30
    23
    Injection site erythema
         subjects affected / exposed
    19 / 203 (9.36%)
    12 / 204 (5.88%)
    21 / 203 (10.34%)
    25 / 202 (12.38%)
         occurrences all number
    20
    13
    21
    25
    Injection site induration
         subjects affected / exposed
    21 / 203 (10.34%)
    13 / 204 (6.37%)
    37 / 203 (18.23%)
    27 / 202 (13.37%)
         occurrences all number
    22
    13
    37
    27
    Injection site pain
         subjects affected / exposed
    112 / 203 (55.17%)
    110 / 204 (53.92%)
    105 / 203 (51.72%)
    111 / 202 (54.95%)
         occurrences all number
    122
    117
    110
    117
    Injection site swelling
         subjects affected / exposed
    58 / 203 (28.57%)
    44 / 204 (21.57%)
    96 / 203 (47.29%)
    70 / 202 (34.65%)
         occurrences all number
    59
    49
    97
    70
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    19 / 203 (9.36%)
    21 / 204 (10.29%)
    26 / 203 (12.81%)
    17 / 202 (8.42%)
         occurrences all number
    20
    24
    26
    17
    Myalgia
         subjects affected / exposed
    69 / 203 (33.99%)
    52 / 204 (25.49%)
    88 / 203 (43.35%)
    79 / 202 (39.11%)
         occurrences all number
    72
    56
    91
    80

    More information

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    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
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