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    Summary
    EudraCT Number:2015-004212-37
    Sponsor's Protocol Code Number:V501-200
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-10-18
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2015-004212-37
    A.3Full title of the trial
    A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity trial of V501 in Japanese boys
    A.3.2Name or abbreviated title of the trial where available
    Safety and Immunogenicity trial of V501 in Japanese boys
    A.4.1Sponsor's protocol code numberV501-200
    A.7Trial is part of a Paediatric Investigation Plan No
    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., Inc.
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMSD K.K.
    B.5.2Functional name of contact pointShinya Murata
    B.5.3 Address:
    B.5.3.1Street Address1-13-12 Kudan-kita
    B.5.3.2Town/ cityChiyoda-ku, Tokyo
    B.5.3.3Post code102-8667
    B.5.3.4CountryJapan
    B.5.4Telephone number+81362721639
    B.5.6E-mailshinya.murata@merck.com
    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 Yes
    D.2.1.1.1Trade name GARDASIL™/SILGARD™
    D.2.1.1.2Name of the Marketing Authorisation holderMSD VACCINS
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameQuadrivalent HPV (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 No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 6 L1 protein
    D.3.9.3Other descriptive nameHPV 6 TYPE L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25327
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 11 L1 protein
    D.3.9.3Other descriptive nameHPV TYPE 11 L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25330
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 16 L1 protein
    D.3.9.3Other descriptive nameHPV TYPE 16 L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25329
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 18 L1 protein
    D.3.9.3Other descriptive nameHPV TYPE 18 L1 PROTEIN ADS. ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PROD. IN S. CEREVISIAE CANADE3C-5 (STRAIN 1895) BY RECOM. DNA TECHNOL.]
    D.3.9.4EV Substance CodeSUB25328
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 condyloma acuminata and anal cancers and related precancers caused by Human Papillomavirus (HPV) 6, 11, 16 and 18
    E.1.1.1Medical condition in easily understood language
    Prevention of HPV related cancers in men
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071147
    E.1.2Term Human papilloma virus immunization
    E.1.2System Organ Class 100000004865
    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 administration of V501 induces high seroconversion rates for the vaccine HPV types (6, 11, 16 and 18) at 4 weeks post dose 3 in 9- to 15-year-old Japanese boys.
    (2) To demonstrate that a 3-dose regimen of V501 to 9- to 15-year-old Japanese boys is well tolerated.
    E.2.2Secondary objectives of the trial
    (1) To demonstrate that administration of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, 11, 16 and 18 at 4 weeks post dose 3 in Japanese boys aged 9- to 15-year-old compared with those in Japanese men aged 16- to 26-year-old in Phase III study (Protocol 122) for V501 at 4 weeks post dose 3.
    (2) To describe the persistence of the serum antibody titers for the vaccine HPV types 24 months following the third dose of V501.
    (3) To estimate the immune response for the vaccine HPV types (6, 11, 16 and 18) at 4 weeks post dose 3 using GMTs.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose
    of the correct drug at the correct time.
    E.3Principal inclusion criteria
    1. Be a healthy, Japanese male between the age of 9 years and 0 days and 15 years and 364 days on the day of the first study vaccination.
    2. Have a legal representative who provides written informed consent for the trial on the subject’s behalf. The legal representative may also provide consent for Future Biomedical Research on the subject’s behalf. However, the subject may participate in the main trial without participating in Future Biomedical Research.
    3. Have a legal representative who is able to read, understand, and complete the vaccine report card.
    4. Agree to provide study personnel with a primary telephone number as well as an alternate telephone number/email address for follow-up purpose.
    5. Show no temperature ≥37.5˚C (oral) within 24 hours prior to vaccinations. If the subject does not meet this criterion, the Day 1 visit will be rescheduled for a time when this criterion can be met.
    6. Must not yet have had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7.
    E.4Principal exclusion criteria
    1. Is concurrently enrolled in clinical studies of investigational agents
    2. Has history of known prior vaccination with an HPV vaccine or plans to receive the HPV vaccine outside of the study.
    3. Has receipt of inactivated vaccines within 14 days prior to enrollment or receipt of live virus vaccines within 28 days prior to enrollment. If the subject meets this criterion, the Day 1 visit will be rescheduled for a time when this criterion is not met.
    4. Has history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
    5. Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]).
    6. Has received any immune globulin or blood derived products within the 6 months prior to the first injection, or plan to receive any through Month 7 of the study.
    7. Has history of splenectomy or 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 auto immune condition.
    8. Is receiving, or has received in the year prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-α antagonists, monocolonal antibody therapies (including rituximab), intravenous gamma globulin, antilymphocyte sera, or other therapy known to interfere with the immune response.
    With regard to systemic corticosteroids, a subject will be excluded if he 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, or topical corticosteroids are considered eligible for the study.
    9. Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
    10. Has history of recent (within the last 12 months) or ongoing alcohol or drug abuse. Alcohol and drug abusers are defined as those who drink or use drugs despite recurrent social, interpersonal, and legal problems as results of alcohol or drug use.
    11. Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the subject’s participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
    12. Is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
    13. Has a history of genital warts or a positive test for HPV.
    14. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
    E.5 End points
    E.5.1Primary end point(s)
    Primary immunogenicity endpoint will be seroconversion rate for the vaccine HPV types (6, 11, 16 and 18).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 4 weeks post dose 3
    E.5.2Secondary end point(s)
    Key secondary endpoint includes cLIA geometric mean titers (GMTs) for the vaccine HPV type (6, 11, 16 and 18).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 4 weeks post dose 3
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity and tolerability
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Japan
    E.8.7Trial has a data monitoring committee No
    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
    The subject participation portion of the overall trial ends when the last subject completes the last study - related phone call or visit, discontinues from the trial or is lost to follow -up (i.e., the subject is unable to be contacted by the investigator). For purposes of analysis and reporting, the overall trial ends when the Sponsor receives the last serology assay result or subject data from the last study-related phone call or visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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.1.1.5.1Number of subjects for this age range: 45
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 55
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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