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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-000112-42
    Sponsor's Protocol Code Number:V501-028
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-01-11
    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 number2017-000112-42
    A.3Full title of the trial
    A Phase II Double-Blind Comparative Study of V501 in Females Aged 9 to 17 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Japan Adolescent Study of V501 in Females Aged 9 to 17 Years
    A.3.2Name or abbreviated title of the trial where available
    A Phase II Double-Blind Comparative Study of V501 in Females Aged 9 to 17 Years
    A.4.1Sponsor's protocol code numberV501-028
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00411749
    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 SponsorBanyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co., Inc, Kenilworth, New Jersey
    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 supportBanyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co., Inc, Kenilworth, New Jersey
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBanyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co., Inc, Kenilworth, New Jersey, U.S.A
    B.5.2Functional name of contact pointShinya Murata
    B.5.3 Address:
    B.5.3.1Street AddressKitanomaru Square, 1-13-12
    B.5.3.2Town/ cityKudan-kita, Chiyoda-ku, Tokyo
    B.5.3.3Post code103-8667
    B.5.3.4CountryJapan
    B.5.4Telephone number+813-6272-1639
    B.5.5Fax number+813-6238-9117
    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
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    vaccination against HPV infection/related disease
    E.1.1.1Medical condition in easily understood language
    vaccination against HPV infection/related disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    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
    Part I

    1) IMMUNOGENICITY
    To evaluate the serum antibody titers to the vaccine HPV types at 1 month Postdose 3 in the subjects recieved the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine compared with placebo.
    2) SAFETY
    To demonstrate that a 3-dose regimen of V501 is generally safe and well tolerated.

    Part II

    1) IMMUNOGENICITY
    To describe the persistence of the serum antibody titers for the vaccine HPV types (Types 6, 11, 16, 18) during 2 years of study period after 3-dose regimen of V501.
    E.2.2Secondary objectives of the trial
    Part I

    1) IMMUNOGENICITY
    To compare the serum antibody titers to the vaccine HPV types (Types 6, 11, 16, 18) at 1 month Postdose 3 in the V501 group with the data of a Japanese phase II double-blind comparative study in females aged 18 to 26 years (PN027).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subjects who satisfy all the criteria below at Visit 1 will be enrolled in the study.
    1) Preadolescent and adolescent girls between the ages 9 years and 17 years.
    2) Must not yet have had coitarche and does not plan on becoming sexually active through the course of the study.
    3) Temperature (oral) measured at the test before the initial injection of the investigational product is <37.5C.
    4) Subject from whom written informed consent form is obtained from the guardian (legal representative) before the start of study (assent should be obtained from the subject whenever possible)
    E.4Principal exclusion criteria
    The subject who violates any of the criteria below at Visit 1 will be excluded from the study.
    1) Concurrent participation in any other trial within 1 month of the start of this study
    2) Positive to the pregnancy test (by a urinary pregnancy test with HCG sensitivity adjusted to 25 IU) at the initial visit of this study. Also a person who wish to become pregnant during the period from the start of investigational vaccination to 7 months after vaccination or a breastfeeding subject.
    3) History of known prior vaccination with a HPV vaccine
    4) Receipt of inactivated vaccines within 14 days before the start of this study or receipt of live virus vaccines within 28 days before the start of this study.
    5) History of serious allergic reaction (e.g., swelling of the mouth and throat, difficulty of breathing, hypotension, or shock) by drug administration.
    6) Allergic to the ingredients of vaccine containing aluminum or to yeast
    7) Treatment with immunoglobulin or any blood-derived products during the 6 months before the start of this study or scheduled treatment with any such product during the study period
    8) Individuals with history of splenectomy, known immune disorder (e.g., systemic erythematosus, rheumatic disease), receiving immunosuppressives (e.g., substances or treatment known to diminish immune response such as radiation therapy, administration of antimetabolite, antilymphocytic sera, oral or parenteral systemic corticosteroid). 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. Those who have received topical (e.g., inhaled or intranasal) corticosteroid therapy may be enrolled.
    9) Thrombocytopenia or coagulopathy that contradicts intramuscular injection
    10) Diagnosed immunodeficiency or HIV infection
    11) Presence or history of alcohol or drug abuse. Alcohol abuse is defined as the failure to abstain from taking alcohol despite repetition of alcohol-related social, interpersonal, and legal troubles.
    12) Any other condition that disqualifies the individual for the study in the opinion of the investigator/subinvestigator
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity endpoints
    Serum antibody titer of each HPV type (HPV 6, HPV 11, HPV 16, and HPV 18)contained in vaccines

    Safety endpoints
    Vital signs (temperature (oral), sitting blood pressure, and pulse rate), laboratory values, injection site reactions, and adverse events
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Immunogenicity: Serum will be collected at Visits 1, 2, 3, 5, 6, and 7. Analysis will occur after Period I and again after Period II
    2. Safety: Analysis will occur after Period I
    a. Vital signs will be measured at Visit 1, 2, 4 or at the time of discontinuation.
    b. Injection site reactions will be observed at Visit 1 2, 4.
    c. Laboratory values: The following examinations will be performed at visit 1, 2, 5 or at the time of discontinuation before visit 5. Hematology: WBC, RBC, hemoglobin, hematocrit, and platelet countBlood Chemistry: Total protein, total bilirubin, AST (GOT), ALT (GPT), BUN, and serum creatinineUrinalysis: Sugars, proteins, and urobilinogen
    d. Adverse events: during the study treatment (including placebo) or during the follow-up period.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 Yes
    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
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    unblinded in Period II
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    LVLS
    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 months9
    E.8.9.2In all countries concerned by the trial days7
    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: 107
    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: 55
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 52
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 2017-01-11. 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 107
    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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