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    Summary
    EudraCT Number:2016-002455-20
    Sponsor's Protocol Code Number:P150957
    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:2016-12-14
    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 number2016-002455-20
    A.3Full title of the trial
    Efficacy study of the quadrivalent Human Papilloma Virus (HPV) vaccine to prevent recurrence of External Genital Warts (EGW) in patients who were cured in the first place
    Étude de l’efficacité de la vaccination anti-PVH (Papilloma Virus Humain) quadrivalente sur la prévention secondaire de la récidive des condylomes ano-génitaux externes chez des patients cliniquement guéris en premier lieu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    CONDYVAC
    A.4.1Sponsor's protocol code numberP150957
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailmireille.toy-miou@aphp.fr
    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 SMC
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameGardasil
    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 INNGardasil
    D.3.9.3Other descriptive nameGardasil
    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 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 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
    Patients whose EGW have just disappeared after initial success of classic treatment
    Patients ayant eu des condylomes ano-génitaux (CAG) externes mais cliniquement guéris
    E.1.1.1Medical condition in easily understood language
    NA
    NA
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10059313
    E.1.2Term Anogenital warts
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate if the HPV vaccine, as compared to placebo, reduces the relapse rate of external genital warts over a 12 month-period after their first injection.
    L'objectif principal est d'évaluer si l'administration du vaccin anti-PVH versus placebo, chez des patients ayant eu des condylomes ano-génitaux (CAG) externes mais cliniquement guéris, permet de réduire le taux de récidives de CAG externes au cours d'une période de 12 mois suivant la première injection du vaccin.
    E.2.2Secondary objectives of the trial
    - To assess the improvement of the quality of life of the patients
    - To investigate the clinical tolerance to three doses of HPV vaccine.
    - évaluer l'amélioration de la qualité de vie des patients.
    - évaluer la tolérance clinique des 3 injections de vaccin anti-PVH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients aged 18 years and older ;
    - Patients who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements ;
    - Patients with a confirmed clinical diagnosis for previous external anogenital warts ;
    - Patient completely cured (no clinically visible lesions) for over two weeks and less than a month prior to inclusion visit (V1, M0) after initial success of classic treatment;
    - Women of childbearing potential must have a negative pregnancy test and an effective contraception from selection visit (V0) and up to the end of the vaccination period of 6 months;
    - Males must have an effective protection with condoms in order to limit the risk of recontamination from selection visit (V0) and up to the end of the vaccination period of 6 months ;
    - Patients affiliated to a social security regimen;
    - Patients able to participate during the 12 months of the study.
    - Patients âgés de 18 ans et plus;
    - Patients qui, après que l'on leur a expliqués la nature de l'étude et avant toute procédure spécifique au protocole, ont donné leur consentement écrit selon des dispositions réglementaires ;
    - Patients ayant un diagnostic clinique confirmé de verrues anogenital externes (condylomes) ;
    - Patients complètement guéris (pas des lésions cliniquement visibles) depuis plus de deux semaines et depuis moins d'un mois avant la visite d'inclusion (M0) après un traitement initial classique réussi ;
    - Femmes en âge de procréer doivent avoir un test de grossesse négatif et une contraception efficace de la visite de sélection (V0) et jusqu'à la fin de la période de vaccination de 6 mois ;
    - Hommes doivent avoir une protection efficace avec des préservatifs afin de limiter le risque de recontamination de la visite de sélection (V0) et jusqu'à la fin de la période de vaccination de 6 mois;
    - Patients affiliés à un régime de sécurité sociale;
    - Patients capables de participer à l'étude pendant les 12 mois ;
    E.4Principal exclusion criteria
    - Patient with diagnosis of internal anogenital warts (intra rectal , intra vaginal, intra urethral) at the selection visit
    - Patients with positive HIV, HCV or HBV (Ag HBS) tests;
    - Patients whose regular partner(s) have an active uncontrolled clinical EGW disease;
    - Patients who received the HPV Vaccine at any time before enrolment to the study;
    - Patients with any serious chronic or progressive disease according to the judgment of the investigator;
    - Patients with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic immunosuppressant medication (more than 14 days) (i.e. prednisone, or equivalent >=10 mg/day) within :
    o the 28 days preceding the first vaccination at the inclusion visit V1 in case of corticosteroids administration
    o the 3 months preceding the first vaccination at the inclusion visit V1 in case of administration of cyclophosphamide, anti-TNF-alpha, intravenous immunoglobulins, abatacep, corticosteroids as a bolus injection
    o the 6 months preceding the first vaccination at the inclusion visit V1 in case of anti CD 20 administration
    or in chemotherapy treatment within the past 180 days (6 months).Topical or inhaled uses of steroid including intranasal are allowed;
    - Patients with history of known allergies/hypersensitivity to any component of study vaccine ;
    - Patients who have any malignancy or lymphoproliferative disorder ;
    - Patients with thrombocytopenia or coagulation disorder contre-indicating intramusculary injections ;
    - Women who are pregnant or are breast-feeding, or are of childbearing age and do not use or do not plan to use acceptable birth control measures, during the first 6 months of the study ;
    - Male who do not use or do not plan to use condoms, during the first 6 months of the study ;
    - Patients under a measure of legal protection or unable to consent ;
    - Patients participating in any clinical trial with another investigational product 28 days prior to first study visit or intent on participating in another clinical study at any time during the conduct of this study.
    - Patients ayant un diagnostic de verrues ano-genitales internes (intra rectal, intra vaginal, intra urétral) à la visite de sélection ;
    - Patients ayant des résultats de tests montrant une sérologie VIH, HCV ou HBV (Ag HBS) positive ;
    - Des patients dont le(s) partenaire(s) régulier(s) a/ont des verrues ano-genitales externes (condylomes) non contrôlées actives;
    - Patients ayant dejà été vaccinés contre le PVH avant la participation à cette l'étude;
    - Patients ayant une maladie chronique ou progressive grave selon le jugement de l'investigateur ;
    - Patients ayant une maladie auto-immune ou toute autre atteinte/altération connue ou suspectée du système immunitaire, ou sous traitement immunosuppresseur, y compris des corticostéroïdes systémiques (ex : prednisone ou équivalent >= 10 mg/jour) dans :
    - les 28 jours précédant la visite d'inclusion pour les corticoïdes
    - les 3 mois précédant la visite d'inclusion pour les cyclophosphamides, anti-TNF-alpha, immunoglobulines intraveineuses, abatacep et les corticostéroïdes pris en bolus
    - les 6 mois précédant la visite d'inclusion pour l'administration anti-CD 20
    ou sous traitement de chimiothérapie dans les 6 derniers mois. L'utilisation topique ou par inhalation de stéroïdes, y compris par voie intra-nasale est autorisée.
    - Patients ayant des antécédents d'allergies / d'hypersensibilité connues à l'un des constituants du vaccin d'étude;
    - Patients ayant un cancer ou un syndrome lymphoprolifératif ;
    - Patients ayant une thrombocytopénie ou un trouble de l'hémostase contre-indiquant les injections intramusculaires ;
    - Femmes enceintes, allaitantes, ou en âge de procréer et n'utilisant pas ou ne prévoyant pas d'utiliser des moyens de contraception acceptables pendant les 6 premiers mois de l'étude;
    - Hommes n'utilisant pas ou ne prévoyant pas d'utiliser des préservatifs pendant les 6 premiers mois de l'étude;
    - Patients sous mesure de protection juridique ou incapable de de formuler son consentement ;
    - Patients participant à une autre recherche biomédicale dans les 28 jours précédant l'inclusion ou ayant l'intention de participer à une autre recherche biomédicale pendant l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the Relapse-free "survival". Relapse will have to be clinically confirmed.
    Le nombre de patients n'ayant eu aucune récidive de CAG externes durant l'étude. Les récidives de CAG externes doivent être confirmées sur le plan clinique par un médecin spécialiste des MST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    E.5.2Secondary end point(s)
    - Disease relief score as evaluated by patients on CECA and DLQI self-administered questionnaires over the treatment and follow-up periods
    2. The clinical tolerance to HPV vaccine will be evaluated by assessment of the percentage of patients with local and/or systemic reactions during the study
    - L'amélioration des scores, obtenus aux questionnaires CECA et DLQI complétés par les patients, toute au long de l'étude.
    - Le pourcentage de patients ayant présenté une réaction locale et/ou systémique au vaccin anti-PVH durant toute la durée de l'étude.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mois
    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 No
    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 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 No
    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 concerned18
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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.4.1In the member state300
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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