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    Summary
    EudraCT Number:2009-016218-26
    Sponsor's Protocol Code Number:V503-007
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-16
    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 ConcernedAustria - BASG
    A.2EudraCT number2009-016218-26
    A.3Full title of the trial
    A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds)
    A.4.1Sponsor's protocol code numberV503-007
    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 Corp., a subsidiary of Merck & Co.
    B.1.3.4CountryUnited States
    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 No
    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 nameNonavalent HPV VLP Vaccine
    D.3.2Product code V503
    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 codeV503
    D.3.9.3Other descriptive name[Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58 Vaccine, Recombinant]
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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 No
    D.3.11.8Extractive medicinal product No
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Repevax
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameDIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT) AND POLIOMYELITIS (INACTIVATED) VACCINE (ADSORBED, REDUCED ANTIGEN(S) CONTENT)
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,5
    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 No
    D.3.11.8Extractive medicinal product No
    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.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 cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, Pap test abnormalities, and persistent infection caused by Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.2Term Human papilloma virus infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety Objective:
    Tolerability of the concomitant administration of a first dose of the 9-valent HPV L1 VLP vaccine with REPEVAX™ in preadolescent and adolescent boys and girls11-15 years of age.
    Immunogenicity Objectives:
    1) To demonstrate that a first dose of the 9-valent HPV L1 VLP vaccine administered concomitantly with REPEVAX™ induces non-inferior anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 Geometric Mean Titers (GMTs) in preadolescent and adolescent boys and girls 11 to 15 years of age compared to the administration of the 9-valent HPV L1 VLP vaccine separately.
    2) To demonstrate that REPEVAX™ administered concomitantly with a first dose of the 9-valent HPV L1 VLP vaccine induces non-inferior immune responses to diphtheria, tetanus, poliovirus types 1,2,and 3, and pertussis in preadolescent and boys and girls 11 to 15 years of age compared to the administration of REPEVAX™ separately.
    E.2.2Secondary objectives of the trial
    To demonstrate that a first dose of the 9-valent HPV L1 VLP vaccine administered concomitantly with REPEVAX™ induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is male or female, between the ages of 11 years and 0 days and 15 years and 364 days on the day of enrollment.
    2. Subject is judged to be in good physical health on the basis of medical history and physical examination.
    3. Parent/legal guardian and subject fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent/assent.
    4. Parent/legal guardian is able to read, understand, and complete the vaccination report card.
    5. Subject and parent/legal guardian agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
    6. Subject must not yet have had coitarche and does not plan on becoming sexually active through the course of the study.
    7. Subject must have previously received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5 year interval to a prior vaccination containing any one of these vaccine antigens.
    E.4Principal exclusion criteria
    1. Subject has a known allergy to any vaccine component of the 9-valent HPV L1 VLP vaccine, REPEVAX™ or residues carried over from manufacture (such as formaldehyde, glutaraldehyde, streptomycin, neomycin, and polymoxin B). Individuals allergic to aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). Subject experienced an allergy to a previous dose of tetanus, diphtheria, poliovirus (inactivated and/or oral poliovirus) or a component pertussis combination (acellular and whole cell) vaccine.
    2. Subject has had a severe reaction affecting the brain (e.g. evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine.
    3. Subject has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus (inactivated and/or oral poliovirus) or a component pertussis combination (acellular and whole cell) vaccine.
    4. Subject ever had Guillain-Barré syndrome (temporary loss of movement and feeling in all or part of the body) or brachial neuritis (loss of movement, pain and numbness of the arm and the shoulder) following a previous dose of a tetanus containing vaccine.
    5. Subject has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™.
    6. Subject has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
    7. Subject has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections.
    8. Subject is concurrently enrolled in clinical studies of investigational agents.
    9. (Female subjects only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL β-hCG).
    10. Subject is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition.
    11. Subject has had a splenectomy.
    12. Subject is receiving or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), TNF-α antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a subject will be excluded if he/she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week in duration in the year prior to enrollment. Subjects using inhaled, nasal, topical, or ocular steroids are considered eligible for the study.
    13. Subject has received any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product within the 3 months prior to the Day 1 vaccination, or plans to receive any such product during the study.
    14. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
    15. Subject has received a tetanus, diphtheria, pertussis, or poliovirus (inactivated and/or oral poliovirus) vaccination administered within the last 5 years.
    16. Subject has a history of a positive test for HPV.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity:
    The primary immunogenicity endpoints for evaluating antibody response to 9-valent HPV L1 VLP vaccine are geometric mean titers (GMTs) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Week 4 Postdose 3.
    The primary immunogenicity endpoints for evaluating antibody response to the diphtheria and tetanus components of REPEVAX™ are the proportions of subjects who achieve antibody titers of at least 0.1 IU/mL one month postvaccination of REPEVAX™, where this is assessed by the Micrometabolic Inhibition Test for diphtheria and by EIA for tetanus. The primary immunogenicity endpoints for pertussis are the GMTs to anti-PT, anti-FHA, anti-FIM and anti-PRN 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™.
    Safety:
    Safety assessment will focus on the injection site adverse experiences for 9-valent HPV L1 VLP vaccine and REPEVAX™ (Day 1 to 5 post vaccination), elevated temperatures (Day 1 to Day 5 post vaccination), and systemic adverse experiences (Day 1 to Day 15 post vaccination) at Day 1, and Month 1 visits as reported on the Vaccination Report Card. To provide a common period of follow-up in both groups, all subjects will complete the VRC after the Month 1 visit, even though the concomitant group will not have been vaccinated at that visit. In addition, serious adverse experiences will be collected for the duration of the study. Injection site adverse experiences and temperatures are further collected Day 1 to Day 5 post Month 2 and Month 6 vaccinations, and systemic adverse experiences are collected Day 1 to Day 15 post Month 2 and Month 6 vaccinations.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    concomitant administration vs. non-concomitant adminstration
    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.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    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 2010-02-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 900
    F.4.2.2In the whole clinical trial 1040
    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 Decision2010-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-16
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