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    Summary
    EudraCT Number:2006-000764-85
    Sponsor's Protocol Code Number:V501-024-00
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2006-000764-85
    A.3Full title of the trial
    A Open-label, Randomized, Multicenter Study of the Safety, Tolerability, and
    Immunogenicity of GARDASIL™ Given Concomitantly with REPEVAX™ in Healthy
    Adolescents 11-17 Years of Age.
    A.4.1Sponsor's protocol code numberV501-024-00
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme BV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGARDASIL (Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine
    D.3.2Product code V501
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeV 501
    D.3.9.3Other descriptive nameGardasil
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameREPEVAX
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameRepevax
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of Human Papillomavirus Infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To demonstrate that a first dose of REPEVAX™ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pastuer, Swiftwater, PA U.S.A.) can be administered concomitantly with the first dose of GARDASIL™† without impairing the antibody response to HPV types 6, 11, 16, and 18, compared to the administration of GARDASIL™ alone.

    2. To demonstrate that the first dose of GARDASIL™ can be administered concomitantly with a first dose of REPEVAX™ without impairing the antibody response to diphtheria, tetanus, pertussis and poliomyelitis, compared to the administration of REPEVAX™ alone.

    3. To demonstrate that concomitant administration of the first dose of GARDASIL™ with REPEVAX™ will be generally well tolerated compared to when the first dose of
    GARDASIL™ is given separately from REPEVAX™.
    E.2.2Secondary objectives of the trial
    To demonstrate that GARDASIL™ made in the final manufacturing facility (FMF) induces similar (noninferior) antibody responses to HPV 6, 11, 16 and 18 compared to GARDASIL™ made in the current manufacturing facility (CMF).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    a. Healthy adolescent boys and girls age 11 to 17 years.

    b. Must agree to provide study personnel with a primary telephone number as
    well as an alternate telephone number for follow-up purposes.

    c. Must agree to refrain from sexual activity throughout the course of the study
    (including vaginal and anal penetration and any genital contact).

    d. Subject must have been previously immunized against diphtheria, tetanus, and
    pertussis (not in the last 5 years).
    E.4Principal exclusion criteria
    a. Individuals concurrently enrolled in clinical studies of investigational agents.

    b. History of known prior vaccination with an HPV vaccine.

    c. Receipt of inactivated vaccines within 14 days prior to enrollment or receipt
    of live virus vaccines within 21 days prior to enrollment.

    d. Has had coitarche or plans to become sexually active through the course of the
    study.

    e. Temperature ≥100°F or ≥37.8°C (oral) within 24 hours prior to the first
    injection

    f. Pregnant now (as determined by a urine pregnancy test sensitive to 25 IU
    HCG).

    g. Individuals allergic to any of the vaccine components of GARDASIL™ or
    REPEVAX™ or residues carried over from manufacture (such as
    formaldehyde, streptomycin, neomycin, and polymoxin B). Individuals who
    have experienced anaphylactic or other allergic reactions to a previous dose of
    tetanus or diptheria or a component pertussis combination vaccine.
    Individuals allergic to aluminum, yeast, phenoxyethanol, or BENZONASE™
    (nuclease, Nycomed [used to remove residual nucleic acids from this and
    other vaccines]).

    i. Individuals who have received any immune globulin preparation (including
    RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived products within
    the 6 months prior to the first injection, or plan to receive any through the
    completion of the study.

    j. Individuals with a history of splenectomy, known immune disorders (e.g.,
    systemic lupus erythematosus, rheumatoid arthritis), or receiving
    immunosuppressives (e.g., substances or treatments known to diminish
    immune response such as radiation therapy, administration of antimetabolites,
    antilymphocytic sera, systemic corticosteroids). Individuals who have
    received periodic treatments with immunosuppressives, defined as at least
    3 courses of systemic corticosteroids each lasting at least 1 week in duration
    for the year prior to enrollment, will be excluded. Subjects using topical,
    inhaled or nasal steroids will be eligible for vaccination.

    k. Individuals with known hemophilia, thrombocytopenia or any coagulation
    disorder that would contraindicate intramuscular injections.

    l. Any condition which in the opinion of the investigator might interfere with the
    evaluation of the study objectives.

    m. Individuals who are immunocompromised or have been diagnosed as having
    HIV infection.

    n. History of recent (within 1 year from the date of enrollment) or ongoing
    alcohol or other drug abuse. Alcohol abusers are defined as those who drink
    despite recurrent social, interpersonal, and legal problems as a result of
    alcohol use.

    o. Inability to give consent/assent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary immunogenicity endpoints for evaluating antibody response to
    GARDASIL™ are geometric mean titers (GMTs) to HPV 6, 11, 16, and 18 at
    Week 4 Postdose 3 and the percentages of subjects who seroconvert for each
    HPV type (6, 11, 16, and 18) by Week 4 Postdose 3. (Seroconversion is
    defined as changing serostatus from seronegative at baseline to seropositive
    by Week 4 Postdose 3, where any subject with a cLIA titer at or above the
    serostatus cutoff for a given HPV type is considered seropositive for that type.
    Previously, the anti-HPV serum cLIA cutoffs for determining serostatus were
    20, 16, 20, and 24 mMU/mL for HPV types 6, 11, 16, and 18, respectively.
    Due to a change in the cLIA assay, these serostatus cutoffs will be updated at
    a later time.)
    The primary immunogenicity endpoints for evaluating antibody response to
    the diphtheria and tetanus components of REPEVAX™ are the proportions of
    subjects who achieve titers of at least 0.1IU/mL one month postvaccination of
    REPEVAX™. The primary immunogenicity endpoints for evaluating
    antibody response to the polio component of REPEVAX™ are the proportions
    of subjects who achieve detectable serum neutralizing antibodies at a ≥1:8
    dilution one month postvaccination of REPEVAX™. The primary
    immunogenicity endpoints for pertussis are the GMTs to anti-PT, anti-FHA,
    anti-PRN and anti-FIM one month postvaccination of REPEVAX™.
    The primary endpoints for evaluation of GARDASIL™ and their
    corresponding noninferiority margins have been chosen based on interactions
    with regulatory agencies (including U.S. FDA) on previous studies. The
    primary endpoints for evaluation of REPEVAX™ and their corresponding
    noninferiority margins have been chosen to be consistent with the pivotal
    licensure studies for that vaccine
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogencity, concomitant use
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Patient Out
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-05-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 800
    F.4.2.2In the whole clinical trial 800
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    see protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
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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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