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    Clinical Trial Results:
    A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®

    Summary
    EudraCT number
    2020-000126-26
    Trial protocol
    FI  
    Global end of trial date
    08 Mar 2021

    Results information
    Results version number
    v1
    This version publication date
    18 Aug 2021
    First version publication date
    18 Aug 2021
    Other versions
    v2

    Trial information

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    Trial identification
    Sponsor protocol code
    V419-013
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04490499
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, 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
    08 Mar 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing will be performed.
    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
    02 Sep 2020
    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
    Finland: 207
    Worldwide total number of subjects
    207
    EEA total number of subjects
    207
    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)
    207
    Adolescents (12-17 years)
    0
    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
    -

    Pre-assignment
    Screening details
    Approximately 200 planned to be enrolled and 207 were enrolled.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    HBVAXPRO™
    Arm description
    Healthy children vaccinated approximately 9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).
    Arm type
    Experimental

    Investigational medicinal product name
    Hepatitis B virus (HBV) vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single 0.5 mL intramuscular dose

    Number of subjects in period 1
    HBVAXPRO™
    Started
    207
    Vaccinated
    205
    Completed
    205
    Not completed
    2
         Withdrawal By Subject
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    HBVAXPRO™
    Reporting group description
    Healthy children vaccinated approximately 9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).

    Reporting group values
    HBVAXPRO™ Total
    Number of subjects
    207 207
    Age Categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    8.4 ± 0.5 -
    Gender Categorical
    Units: Subjects
        Female
    97 97
        Male
    110 110
    Race
    Units: Subjects
        Multiple
    2 2
        White
    205 205
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    2 2
        Not Hispanic or Latino
    205 205

    End points

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    End points reporting groups
    Reporting group title
    HBVAXPRO™
    Reporting group description
    Healthy children vaccinated approximately 9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).

    Primary: Percentage of Participants with a Protective Hepatitis B Surface Antibody Level of ≥10 milli International Units/mL (mIU/mL) at 30 Days Post-Challenge with HBVAXPRO™

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    End point title
    Percentage of Participants with a Protective Hepatitis B Surface Antibody Level of ≥10 milli International Units/mL (mIU/mL) at 30 Days Post-Challenge with HBVAXPRO™ [1]
    End point description
    Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge. The analysis population consisted of all enrolled participants without deviations from the protocol (i.e., did not receive study vaccine, use of prohibited medicine/vaccine, or blood sample collected outside of analysis window) that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Primary
    End point timeframe
    Day 30
    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: This is a single arm study, and subjects were enrolled in the same vaccination group. Also, this is an estimation study, and no formal hypothesis testing was performed.
    End point values
    HBVAXPRO™
    Number of subjects analysed
    202
    Units: Percentage of Participants
        number (confidence interval 95%)
    99.5 (97.3 to 100.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen

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    End point title
    Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
    End point description
    Participant serum samples will be assessed with an ECi assay for anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ in mIU/mL. The analysis population consisted of all enrolled participants without deviations from the protocol (i.e., did not receive study vaccine, use of prohibited medicine/vaccine, or blood sample collected outside of analysis window) that may substantially affect the results of the immunogenicity endpoint.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 30
    End point values
    HBVAXPRO™
    Number of subjects analysed
    205
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Day 1 Pre-challenge (n=205)
    9.63 (7.88 to 11.76)
        Day 30 Post-challenge (n=202)
    685.84 (605.67 to 776.63)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to Day 30
    Adverse event reporting additional description
    The analysis population included all participants who received study vaccine and had safety follow-up data after the vaccination. The all cause mortality analysis population included all enrolled participants. Per protocol, reported non-serious adverse events only include non-serious adverse events that lead to study discontinuation.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    HBVAXPRO™
    Reporting group description
    Healthy children vaccinated approximately 9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).

    Serious adverse events
    HBVAXPRO™
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 205 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    HBVAXPRO™
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 205 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: In the vaccinated participant population, no adverse events (AEs) resulting in discontinuation from study were reported.

    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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