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    Summary
    EudraCT Number:2009-015500-26
    Sponsor's Protocol Code Number:V503-006
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-06-03
    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 number2009-015500-26
    A.3Full title of the trial
    A Phase III Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™
    A.4.1Sponsor's protocol code numberV503-006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01047345
    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 pointAlain Luxembourg
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive- P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, NJ
    B.5.3.3Post code 08889-0100
    B.5.3.4CountryUnited States
    B.5.6E-mailalain_luxembourg@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 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.3.4Pharmaceutical 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 9-valent Vaccine (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
    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
    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.
    E.1.1.1Medical condition in easily understood language
    Prevention of human papillomavirus (HPV) infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.2Term Human papilloma virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    V503-006-01 Base Study
    Objective: To evaluate the tolerability of the 9vHPVvaccine in adolescent girls and young women 12 to 26 years of age who have previously received a 3-dose regimen of GARDASIL.

    Safety Objective (V503-006-02 Study Extension)
    Objective: To describe the incidence of serious adverse experiences in adolescent girls and young women 12 to 26 years of age who received 9vHPV vaccine subsequent to receiving a 3-dose regimen of GARDASIL™.
    E.2.2Secondary objectives of the trial
    V503-006-01 Base Study
    Objective: To demonstrate that the 9vHPV vaccine is immunogenic with respect to HPV Types 31, 33, 45, 52, and 58 in adolescent girls and young women 12 to 26 years of age who have previously received a 3-dose regimen of GARDASIL

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Base study
    1. Participants Age 12 to 15 Years:
    -Participant is in good health
    - Parent/legal guardian and participant agree to provide study personnel with a primary telephone number for follow-up
    - Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
    - Participant has not received any other HPV vaccine
    - Participant is not yet sexually active
    2. Participants Age 16 to 26 Years:
    - Participant is in good health
    - Participant agrees to provide a primary telephone number for follow-up
    - Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and the last dose of GARDASIL™ was at least 1 year from study day 1
    - Participant has not received any other HPV vaccine
    - Participant has never had Papanicolaou (Pap) testing or has only had normal results
    - Participant has a history of 0 to 4 lifetime sexual partners at enrollment

    Study Extension
    To be enrolled and receive the first study vaccination, subjects should meet all inclusion criteria. For items with an asterisk (*), if the subject does not meet these inclusion criteria, the first V503-006-02 vaccination visit may be rescheduled for a time when these criteria can be met.
    1. Subject was enrolled in the V503-006-01 base study between 12 and 26 years of age and was randomized to the placebo cohort.
    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/assent.
    4. Parent/legal guardian and subject agree to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
    5. *Since the first day of the subject’s last menstrual period through Day 1 (Visit 5 of V503-006-2 extension), the subject has not had sex with males or has had sex with males and used effective contraception with no failures.
    E.4Principal exclusion criteria
    Base study
    1. All participants:
    -Participant has a history of severe allergic reaction that required medical intervention
    -Participant has any disorder that would contraindicate intramuscular injections
    -Participant is pregnant
    -Participant is immunocompromised or has an autoimmune condition
    -Participant has had a splenectomy
    -Participant has received any immune globulin product or blood-derived product
    -Participant has participated in a HPV vaccine clinical trial
    -Participants Age 16 to 26 Only:
    -Participant expects to donate eggs during the study
    -Participant has a history of abnormal cervical biopsy result
    -Participant has a history of HPV-related external genital lesions, external genital cancer, HPV-related vaginal lesions, or vaginal cancer


    Study Extension
    To be enrolled and receive the first study vaccination, subjects should not meet any exclusion criteria. For items with an asterisk (*), if the subject meets the exclusion criteria, the Day 1 visit may be rescheduled for a time when these criteria are not met.
    1. Subject has a known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™.
    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. Subject is pregnant (as determined by a serum pregnancy test or urine pregnancy test that is sensitive to 25 mIU/mL β-hCG).
    6. 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.
    7. Subject has had a splenectomy.
    8. Subject is receiving or has received in the year prior to enrollment the immunosuppressive therapies defined in the protocol.
    9. Subject has received any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product within the 3 months prior to the first V503-006-02 vaccination visit.
    10. *Subject has received non-replicating (inactivated) vaccines within 14 days prior to the first V503-006-02 vaccination visit or has received replicating (live) vaccines within 21 days prior to the first V503-006-02 vaccination visit.
    11. *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 first V503-006-02 vaccination visit.
    12. Subject 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.
    13. Subject is unable to give consent/assent.
    14. Subject is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
    15. Subject is, at the time of signing informed consent/assent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug abuse or dependence.

    E.5 End points
    E.5.1Primary end point(s)
    1.Percentage of Participants Who Experience an Injection-site Adverse Event (AE) - Base Study
    2.Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) - Base Study
    3.Percentage of Participants Who Experience a Systemic AE - Base Study
    4.Percentage of Participants Who Experience a Serious Adverse Event (SAE) Within 15 Days of Any Vaccination - Base Study
    5.Percentage of Participants Who Experience a Vaccine-related SAE Any Time During Study- Base Study
    6.Percentage of Participants Who Experience a Severe Injection-site AE - Base Study
    7. Percentage of Participants Who Experience an SAE-Extension Study
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.up to 5 days after any vaccination - Base Study
    2.up to 5 days after any vaccination - Base Study
    3.up to 14 days after any vaccination - Base Study
    4.up to 14 days after any vaccination - Base Study
    5.up to 7 months - Base Study
    6.up to 5 days after any vaccination - Base Study
    7. up to Month 7 - Extension Study
    E.5.2Secondary end point(s)
    Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine - Base Study
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks post-vaccination 3 (Month 7; End of Base Study)
    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
    Tolerability and 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 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
    open-label extension
    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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    Canada
    Colombia
    Hong Kong
    Mexico
    Puerto Rico
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    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: 331
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 331
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 593
    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 No
    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 924
    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: United States
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