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    Summary
    EudraCT Number:2019-003236-23
    Sponsor's Protocol Code Number:V503-049
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-08
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2019-003236-23
    A.3Full title of the trial
    A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the prevention of oral persistent infection with HPV Types 16, 18, 31, 33, 45, 52, or 58 in adult males, 20 to 45 years of age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, immunogenicity, and safety of the 9vHPV vaccine in adult males 20 to 45 years of age
    A.3.2Name or abbreviated title of the trial where available
    Efficacy, immunogenicity, and safety of the 9vHPV vaccine in adult males 20 to 45 years of age
    A.4.1Sponsor's protocol code numberV503-049
    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 pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive P.O. Box 100
    B.5.3.2Town/ cityWhitehouse Station, New Jersey
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.5Fax number+1267305 6431
    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 (9vHPV vaccine)
    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.3.9.2Current sponsor codeV503
    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 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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Oral persistent infection caused by any of the human papillomavirus types 16, 18, 31, 33, 45, 52, and 58
    E.1.1.1Medical condition in easily understood language
    Oral Persistent 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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10006524
    E.1.2Term Buccal cavity papilloma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To demonstrate that a 3-dose regimen of the 9-valent human papillomavirus vaccine (9vHPV) vaccine will reduce the incidence of human papillomavirus (HPV)16/18/31/33/45/52/58-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age
    E.2.2Secondary objectives of the trial
    - To demonstrate that a 3-dose regimen of the 9-valent human papillomavirus vaccine (9vHPV) vaccine will reduce the incidence of human papillomavirus (HPV) 6/11-related oral persistent infection 6 months (± 1-month window) or longer compared with placebo in males 20 to 45 years of age.
    - To summarize antibody responses (Geometric Mean Titer [GMT] and seroconversion percentages) to each of human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52, and 58 at Month 7
    - To evaluate the safety and tolerability of the 9-valent human papillomavirus vaccine (9vHPV) vaccine when administered to males 20 to 45 years of age
    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 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.Is healthy and is judged to be in good physical health based on medical history and physical examination
    2.Is male, from 20 years to 45 years of age inclusive, at the time of signing the informed consent
    3.Provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
    4.Agrees to provide study personnel with a primary telephone number as well as an alternate means of contact, if available (such as an alternate telephone number or email) for follow-up purposes
    5.Can read, understand, and complete the eVRC
    6.Has had at least 1 lifetime sexual partner
    E.4Principal exclusion criteria
    1.Has a history of HPV-related anal lesion (anal intraepithelial neoplasia or anal cancer) or HPV-related head and neck cancer
    2.Has a history of or clinical evidence at the Day 1 external genital examination of HPV-related external lesion (condyloma acuminata, penile intraepithelial neoplasia or penile cancer)
    3.Has clinical evidence at the Day 1 external genital examination of gross genital lesion suggesting sexually transmitted disease
    4.Has a fever (defined as oral temperature ≥100.0°F or ≥37.8°C) within the 24-hour period prior to the Day 1 visit*
    5.Has a history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
    6.Is allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]). For this exclusion criterion, an allergy to vaccine components is defined as an allergic reaction that met the criteria for severe AEs or SAEs
    7.Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
    8.Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
    9.Has a history of splenectomy
    10.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 participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate by judgement of investigator
    11.Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems because of alcohol use
    12.Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (AravaTM), TNF-α antagonists, monoclonal antibody therapies (including rituximab [Rituxan™]), IVIG, antilymphocyte sera, or other therapy known to interfere with the immune response. Regarding systemic corticosteroids, a participant will be excluded if he is currently receiving steroid therapy, has recently (defined as within 2 weeks of Day 1 vaccination) received such therapy, or has received 2 or more courses of high-dose corticosteroids (≥20 mg/day of prednisone [or equivalent] orally or parenterally) lasting at least 1 week in duration in the year prior to Day 1 vaccination. Participants using inhaled, nasal, or topical steroids are considered eligible for the study.
    13.Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product (including RhoGAM™ [Ortho-Clinical Diagnostics]) or blood-derived product other than IVIG
    14.Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 21 days prior to Day 1 vaccination*
    15.Is concurrently enrolled in other clinical studies of investigational agents
    16.Has previously received a marketed HPV vaccine, or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo)
    17.Has engaged in sexual activity 48 hours prior to Day 1 (this may result in the detection of viral DNA that has been deposited in the oral cavity and is not the result of ongoing infection)*
    Sexual activity is defined as:
    -Penile penetrative vaginal intercourse with female partner
    -Penile penetrative or receptive anal intercourse with male or female partner
    -Oral sex involving any contact between participant’s mouth with a female partner’s vagina or genital area or male partner’s penis or genital area
    18.Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled
    19.Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study
    *: For items denoted with an asterisk, if the exclusion criterion is met, then the Day 1 visit may be rescheduled for a time when the criterion is not met.
    E.5 End points
    E.5.1Primary end point(s)
    1.Incidence of Human Papillomavirus (HPV)16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Up to Month 42
    E.5.2Secondary end point(s)
    1.Incidence of Human Papillomavirus (HPV) 6/11-related 6-month Persistent Oral Infection
    2.Geometric Mean Titers to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies
    3.Percentage of Participants who Seroconvert to Human Papillomavirus (HPV) Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
    4.Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)
    5.Percentage of Participants with Elevated Temperature (Fever)
    6.Percentage of Participants who Report at Least 1 Systemic Adverse Event
    7.Percentage of Participants who Experience at Least 1 Serious Adverse Event (SAE)
    8.Percentage of Participants who Experience at Least 1 Serious Vaccine-Related Adverse Event
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.Up to Month 42
    2.1 month postdose 3 (Month 7)
    3.1 month postdose 3 (Month 7)
    4.Up to 5 days after any vaccination
    5.Up to 5 days after any vaccination
    6.Up to 15 days after any vaccination
    7.Up to 15 days after any vaccination
    8.Up to Month 42
    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
    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 No
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    Colombia
    Czech Republic
    France
    Germany
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Peru
    Spain
    Taiwan
    Thailand
    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
    The overall study ends when the last participant completes the last study-related telephone-call or visit, withdraws from the study, or is lost to follow-up (ie, the participant is unable to be contacted by the investigator).For purposes of analysis and reporting, the overall study ends when the Sponsor receives the last laboratory result or at the time of final contact with the last participant, whichever comes last.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6000
    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.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1620
    F.4.2.2In the whole clinical trial 6000
    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)
    After the study is completed, recipients of placebo will be offered vaccination with the 9vHPV vaccine in an extension study as allowed by relevant local regulations and authorities.
    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 Decision2020-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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