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    Clinical Trial Results:
    A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, from the Russian Population

    Summary
    EudraCT number
    		 2015-001656-29
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    17 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    V110-018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01734239
    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)
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Oct 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine if Pneumovax™ 23 (V110) is safe and immunogenic in participants from the Russian population who are 50 years of age and older or 2 to 49 years of age and at increased risk for pneumococcal disease.
    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
    03 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Russian Federation: 102
    Worldwide total number of subjects
    102
    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)
    18
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    61
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study enrolled participants >=50 years of age and participants 2 to 49 years of age who have increased risk for pneumococcal disease. Additional inclusion and exclusion criteria applied.

    Pre-assignment
    Screening details
    		 A total of 102 participants were screened and enrolled.

    Period 1
    Period 1 title
    Vaccination and Follow-up (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pneumovax™ 23
    Arm description
    		 Participants between 2 and 49 years of age with increased risk for pneumococcal disease received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1. Follow-up was to Day 28.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pneumovax™ 23
    Investigational medicinal product code
    Other name
    V110
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1. Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F.

    Number of subjects in period 1
    		Pneumovax™ 23
    Started
    102
    Completed
    102

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pneumovax™ 23
    Reporting group description
    		 Participants between 2 and 49 years of age with increased risk for pneumococcal disease received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1. Follow-up was to Day 28.

    Reporting group values
    		 Pneumovax™ 23 Total
    Number of subjects
    		 102 102
    Age categorical
    Units: Subjects
        2 to 49 years
    		 52 52
        >=50 years
    		 50 50
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.4 ± 23.1 -
    Gender categorical
    Units: Subjects
        Female
    		 37 37
        Male
    		 65 65

    End points

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    End points reporting groups
    Reporting group title
    Pneumovax™ 23
    Reporting group description
    		 Participants between 2 and 49 years of age with increased risk for pneumococcal disease received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1. Follow-up was to Day 28.

    Primary: Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine

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    End point title
    		 Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes Contained in the Vaccine [1]
    End point description
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. Per protocol, pneumococcal serotypes 1, 6B, 14, 19F, and 23F were assessed. The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range.
    End point type
    Primary
    End point timeframe
    Prevaccination and Day 28 after vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal hypotheses were tested in this study.
    End point values
    		 Pneumovax™ 23
    Number of subjects analysed
    100
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Serotype 1 prevaccination
    0.2 (0.2 to 0.3)
        Serotype 1 Day 28 postvaccination
    3.2 (2.5 to 4.2)
        Serotype 6B prevaccination
    0.6 (0.4 to 0.7)
        Serotype 6B Day 28 postvaccination
    3.7 (2.8 to 5)
        Serotype 14 prevaccination
    2.1 (1.6 to 2.9)
        Serotype 14 Day 28 postvaccination
    20.4 (15.3 to 27.3)
        Serotype 19F prevaccination
    1.5 (1.2 to 1.9)
        Serotype 19F Day 28 postvaccination
    11.3 (8.8 to 14.3)
        Serotype 23F prevaccination
    0.8 (0.6 to 1.1)
        Serotype 23F Day 28 postvaccination
    6.5 (4.9 to 8.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants with >=2-fold Increase from Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine

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    End point title
    		 Percentage of Participants with >=2-fold Increase from Prevaccination to Postvaccination in Antibodies to Pneumococcal Serotypes Contained in the Vaccine [2]
    End point description
    Serum antibodies to pneumococcal serotypes were measured by enzyme-linked immunosorbent assays. A >=2-fold increase in serum antibody is a marker for serologic response to pneumococcal vaccination in adults. Per protocol, pneumococcal serotypes 1, 6B, 14, 19F, and 23F were assessed. The per protocol immunogenicity population included all enrolled participants except 2 who were excluded because blood samples were collected outside the allowable day range.
    End point type
    Primary
    End point timeframe
    Day 28 postvaccination
    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 formal hypotheses were tested in this study.
    End point values
    		 Pneumovax™ 23
    Number of subjects analysed
    100
    Units: Percentage of participants
    number (confidence interval 95%)
        Serotype 1
    92 (84.8 to 96.5)
        Serotype 6B
    83 (74.2 to 89.8)
        Serotype 14
    89 (81.2 to 94.4)
        Serotype 19F
    81 (71.9 to 88.2)
        Serotype 23F
    84 (75.3 to 90.6)
    No statistical analyses for this end point

    Primary: Number of Participants with Elevated Body Temperature (>=37.6 °C Axillary/ >=38.0 °C Oral or Equivalent)

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    End point title
    		 Number of Participants with Elevated Body Temperature (>=37.6 °C Axillary/ >=38.0 °C Oral or Equivalent) [3]
    End point description
    The All Subjects as Treated population included all enrolled participants.
    End point type
    Primary
    End point timeframe
    Up to 5 days postvaccination
    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 formal hypotheses were tested in this study.
    End point values
    		 Pneumovax™ 23
    Number of subjects analysed
    102
    Units: Number of participants
    1
    No statistical analyses for this end point

    Primary: Number of Participants Reporting an Injection-site or Systemic Adverse Experience that was Reported by >=4 Participants

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    End point title
    		 Number of Participants Reporting an Injection-site or Systemic Adverse Experience that was Reported by >=4 Participants [4]
    End point description
    An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor’s product, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the sponsor’s product, is also an AE. Injection-site or systemic AEs that occurred in >=4 participants were reported for this endpoint. The All Subjects as Treated population included all enrolled participants.
    End point type
    Primary
    End point timeframe
    Up to Day 14 postvaccination
    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 formal hypotheses were tested in this study.
    End point values
    		 Pneumovax™ 23
    Number of subjects analysed
    102
    Units: Number of participants
    21
    No statistical analyses for this end point

    Primary: Number of Participants Reporting Serious Adverse Experiences

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    End point title
    		 Number of Participants Reporting Serious Adverse Experiences [5]
    End point description
    A serious adverse event is an AE that 1) results in death, 2) is life threatening, 3) results in a persistent or significant disability or incapacity, 4) results in or prolongs an existing inpatient hospitalization, 5) is a congenital anomaly or birth defect, 6) is a cancer, 7) is an overdose, or 8) is another important medical event which, based on appropriate medical judgment, may jeopardize the participant and may require medical or surgical intervention. The All Subjects as Treated population included all enrolled participants.
    End point type
    Primary
    End point timeframe
    Up to Day 28 postvaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal hypotheses were tested in this study.
    End point values
    		 Pneumovax™ 23
    Number of subjects analysed
    102
    Units: Number of participants
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse experiences were collected through Day 14 postvaccination; serious adverse experiences were collected through Day 28 postvaccination.
    Adverse event reporting additional description
    Participants received a single, 0.5-mL intramuscular injection of Pneumovax™ 23 on Day 1. Follow-up was to Day 28.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Pneumovax™ 23: All Participants
    Reporting group description
    		 -

    Serious adverse events
    		 Pneumovax™ 23: All Participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 102 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pneumovax™ 23: All Participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 102 (13.73%)
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    14 / 102 (13.73%)
         occurrences all number
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2013
    Protocol Amendment V110-018-01 included the following changes: 1) added urinalysis, complete blood count (CBC) and blood chemistry laboratory test procedures prior to vaccination at Visit 1 (Day 1) and at Visit 2 (Day 28) for all subjects, 2) created a new protocol section to add the urinalysis procedure prior to vaccination at Visit 1 (Day 1) and at Visit 2 (Day 28) for all subjects, 3) changed Section title from “Serum Collection” to “Blood Sample Collection”, added text to state that 2 mL whole blood will be collected to perform CBC prior to vaccination at Visit 1 (Day 1) and at Visit 2 (Day 28) for all subjects, added text to state that 2 mL serum will be collected to perform blood chemistry prior to vaccination at Visit 1 (Day 1) and at Visit 2 (Day 28) for all subjects, and 4) added text to state that results of the urinalysis, CBC and blood chemistry prior to vaccination at Visit 1 (Day 1) and at Visit 2 (Day 28) will be summarized.

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

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

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