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    Summary
    EudraCT Number:2004-002945-10
    Sponsor's Protocol Code Number:V501-020
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-11-18
    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
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-002945-10
    A.3Full title of the trial
    A Study to Evaluate the Efficacy of Quadrivalent HPV (Types 6, 11, 16, and 18) L1 Virus-Like Particle (VLP) in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related Anogenital Warts, and the Incidence of HPV 6-, 11-, 16-, and 18-Related Genital Infection in 16- to 23-Year-Old Men
    A.3.2Name or abbreviated title of the trial where available
    HPV Vaccine Efficacy Study in Young Men
    A.4.1Sponsor's protocol code numberV501-020
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSuomen MSD OY
    B.1.3.4CountryFinland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameHuman Papillomavirus (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 Information not present in EudraCT
    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 Recombinant Vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 11 Recombinant Vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 16 Recombinant Vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Papillomavirus Type 18 Recombinant Vaccine
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Human Papillomavirus Infections
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10063001
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Safety Objective:
    To demonstrate that a 3-dose regimen of quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when administered at 0, 2, and 6 months, is generally well tolerated in 16- to 23-year-old men.

    Primary Efficacy Objective:
    To demonstrate that quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when given in a 3-dose regimen, reduces the incidence of HPV 6-, 11-, 16- or 18-related anogenital warts in 16- to 23-year-old men who are naïve to the relevant HPV type, compared with placebo.

    MSM Substudy Efficacy Objective:
    To investigate the impact of administration of a 3-dose regimen of quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine on the combined incidence of HPV 6-, 11-, 16-, or 18-related Anal Intraepithelial Neoplasia (AIN) or Anal Cancer in MSM subjects who are naïve to the relevant HPV type.
    E.2.2Secondary objectives of the trial
    Secondary Efficacy Objectives: (1) To demonstrate that quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when given in a 3-dose regimen, reduces the incidence of persistent HPV 6, 11, 16, or 18 infection in 16- to 23-year-old men who are naïve to the relevant HPV type, compared with placebo (refer to Section I.F.1. for the definition of persistent infection). (2) To demonstrate that quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine, when given in a 3-dose regimen, reduces the incidence of HPV 6, 11, 16, or 18 detection at one or more visits, in 16- to 23-year-old men who are naïve to the relevant HPV type, compared with placebo.

    Immunogenicity Objective: To evaluate the vaccine-induced serum anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 responses in 16- to 23-year-old men.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Candidate subjects must meet ALL of the following:
    a. Healthy, males between the ages 16 years and 0 days and 23 years and 364 days.
    b. No clinical evidence of gross genital lesion suggesting sexually-transmitted disease, and no clinically present anogenital warts.
    c. No temperature ≥100°F or ≥37.8°C (oral) within 24 hours prior to vaccinations (vaccinations can be scheduled at a later date when the temperature falls into normal range).
    d. Must agree to refrain from sexual activity (including vaginal and anal penetration and any genital contact) for 2 calendar days prior to any scheduled visit that includes sample collection, to avoid detection of viral DNA which has been deposited in the male genital area during sexual intercourse and is not the result of ongoing infection.
    e. Individuals who have experienced sexual debut but have had no more than 5 lifetime sexual partners. For protocol purposes, a female sexual partner is defined as a woman with whom the subject has engaged in vaginal intercourse. For protocol purposes, a male sexual partner is defined as a man with whom the subject engaged in insertive or receptive anal intercourse.
    f. Must agree to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes.
    g-1) Additional inclusion criteria for heterosexual male subjects
    Subjects must be a heterosexual male, who has had exclusively female sexual partners.
    g-2) Additional inclusion criteria for MSM subjects
    Subjects must have engaged in either insertive or receptive anal intercourse with another male sexual partner within the past year.
    E.4Principal exclusion criteria
    Candidate subjects who manifest ANY of the following exclusion criteria at the time of randomization will NOT be eligible for the study:
    a. Individuals concurrently enrolled in clinical studies of investigational agents or studies involving collection of genital specimens.
    b. History of known prior vaccination with an HPV vaccine.
    c. Receipt of inactivated vaccines within 14 days prior to enrollment or receipt of live virus vaccines within 21 days prior to enrollment.
    d. Individuals who have history of anogenital warts, or who have clinically present anogenital warts at Day 1.
    e. History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
    f. Individuals allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed [used to remove residual nucleic acids from this and other vaccines]).
    g. Individuals who have 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.
    h. Individuals with history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish the immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of oral corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled or nasal) will be eligible for vaccination.
    i. Individuals who are immunocompromised or have been diagnosed as having Human Immunodeficiency Virus (HIV) infection.
    j. Individuals with known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
    k. 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.
    l. Any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
    m. Any plan to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled.
    n. Individuals with fewer than one or >5 lifetime sexual partners.
    o.Inability to give informed consent/assent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is HPV 6-, 11-, 16-, 18-related anogenital warts. This endpoint will occur if there is:
    –Pathology Panel consensus diagnosis of anogenital warts; AND
    –Detection of HPV 6, 11, 16, or 18 DNA by Thinsection PCR in an adjacent section of the same external anogenital lesion biopsy block.
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 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 Yes
    E.8.2.3Other No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Last Patient Out
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 365
    F.4.2.2In the whole clinical trial 2700
    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)
    Refer to protocol
    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 Decision2005-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-22
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