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    Summary
    EudraCT Number:2013-001314-15
    Sponsor's Protocol Code Number:V503-010
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-03-22
    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 number2013-001314-15
    A.3Full title of the trial
    A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, administered in Preadolescents and Adolescents (9 to 14 year olds) with a Comparison to Young Women (16 to 26 year olds)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III Study of 2 doses of V503 in 9 to 14 year-olds Compared to Young Women
    A.4.1Sponsor's protocol code numberV503-010
    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 organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    B.5.2Functional name of contact pointAmanda Jane Vettori
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305-7696
    B.5.5Fax number+1267305-6529
    B.5.6E-mailAmanda_Vettori@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®9
    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.3.4Pharmaceutical 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 VACCINE [TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58] (RECOMBINANT, ADSORBED)
    D.3.9.3Other descriptive nameHUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58] (RECOMBINANT, ADSORBED)
    D.3.9.4EV Substance CodeSUB130921
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 60
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This study is to study the tolerability and immunogenicity of V503, specific conditions (efficacy endpoints) are not being investigated in this study.
    E.1.1.1Medical condition in easily understood language
    Specific conditions are not being investigated in this study.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    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 administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 & Month 6 induces non-inferior GMTs for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, & anti-HPV 58 in 9 to 14 year old girls compared to 16 to 26 year old young women receiving 3 doses.
    2)To demonstrate administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 & Month 6 induces non-inferior GMTs for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, & anti-HPV 58 in 9 to 14 year old boys compared to 16 to 26 year old young women receiving 3 doses.
    3)To demonstrate administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 12 induces non-inferior GMTs for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18, anti-HPV 31, anti-HPV 33, anti-HPV 45, anti-HPV 52, & anti-HPV 58 in 9 to 14 year old boys & girls compared to 16 to 26 year old women receiving 3 doses.
    E.2.2Secondary objectives of the trial
    1) Objective: To demonstrate that the administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 6 induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in 9 to 14 year old girls compared to 16 to 26 year old young adult women.
    2) Objective: To demonstrate that the administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 6 induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in 9 to 14 year old boys compared to 16 to 26 year old young adult women.
    3) Objective: To demonstrate that the administration of a 2-dose 9-valent HPV L1 VLP vaccine at Day 1 and Month 12 induces non-inferior immune responses with respect to seroconversion percentages to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in 9 to 14 year old boys and girls compared to 16 to 26 year old young adult women.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Boys and Girls Age 9 to 14 Years
    1. Subject is male or female, between the ages of 9 years and 14 years on the day of enrollment.
    2. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
    3. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    4. Subject must not yet have had coitarche and does not plan on becoming sexually active during the vaccination period (Day 1 through Month 7 or Day 1 through Month 13).
    Inclusion Criteria: Women Age 16 to 26 Years
    For items with an asterisk (*), if the subject does not meet these inclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria can be met.
    5. Subject is female, between the ages of 16 and 26 years on the day of enrollment.
    6. Subject is judged to be in good physical health on the basis of medical history, physical examination, and laboratory results.
    7. Subject (or, for minor subjects, parent/legal guardian and subject) fully understands study procedures, alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
    8. Subject has never had Pap testing or has only had normal Pap test results.
    9. Subject has a lifetime history of 0 to 4 male and/or female sexual partners at the time
    of enrollment.
    10. *Since the first day of the subject’s last menstrual period through Day 1, the subject has not had sex with males or has had sex with males and used effective contraception with no failures (an example of a failure is a male condom that ruptures during sexual intercourse).
    E.4Principal exclusion criteria
    1. Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For the purpose of this exclusion criterion, an allergy tovaccine components is defined as an allergic reaction that met the criteria for serious adverse experiences.
    2. 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.
    3. Subject has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
    4. Subject is concurrently enrolled in clinical studies of investigational agents.
    5. (Females only) - Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL β-hCG).
    6. (Young Adult Women only - 16 to 26 years of age) - Subject is expecting to donate eggs during Day 1 through Month 7 of the study.
    7. 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.
    8. Subject has had a splenectomy.
    9. Subject is receiving or has received in the year prior to enrollment certain immunosuppressive therapies.
    10. 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 Day 1 through Month 7 or Day 1 through Month 13 of the study.
    11. *Subject has received non-replicating (inactivated) vaccines within 14 days prior to the Day 1 vaccination or has received replicating (live) vaccines within 21 days prior to the Day 1 vaccination.
    12. Subject has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical trial and has received either active agent or placebo.
    13. *Subject has had a fever (defined as an oral temperature of ≥100°F or ≥37.8°C) within the 24-hour period prior to the Day 1 vaccination.
    14. Subject is unable to give consent/assent.
    15. Subject has a history of a positive test for HPV.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints
    The primary immunogenicity endpoints are HPV-9 cLIA geometric mean titers (GMTs) to HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 at 4 weeks post last dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As stated above
    E.5.2Secondary end point(s)
    Immunogenicity Endpoints
    The secondary immunogenicity endpoints are the HPV-9 cLIA seroconversion percentages to each of HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 by 4 weeks post last dose. Seroconversion is defined as changing serostatus from seronegative to seropositive, by 4 weeks post last dose. A subject with a HPV-9 cLIA titer at or above the serostatus cutoff for a given HPV type is considered seropositive for that type.

    Safety Endpoints
    Safety assessment will focus on the serious adverse experiences which will be collected for
    the duration of the study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As stated above
    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
    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.8.3 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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Canada
    Chile
    Colombia
    Israel
    Korea, Democratic People's Republic of
    Mexico
    South Africa
    Thailand
    Turkey
    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 years3
    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: 1260
    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: 600
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 660
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 240
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 1500
    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)
    Not applicable
    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: Israel
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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
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