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    Summary
    EudraCT Number:2011-006002-27
    Sponsor's Protocol Code Number:CHUBX2011/18
    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:2012-01-05
    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 number2011-006002-27
    A.3Full title of the trial
    Multicentre trial evaluating the immunogenicity of HPV vaccination in girls on immunosuppressive therapy.
    Essai clinique multicentrique évaluant la réponse immunologique de la vaccination contre l’infection par les papillomavirus humains (HPV) 6, 11, 16, 18 chez des jeunes filles recevant un traitement immunosuppresseur
    A.3.2Name or abbreviated title of the trial where available
    PRIMAVERA
    PRIMAVERA
    A.4.1Sponsor's protocol code numberCHUBX2011/18
    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 SponsorCHU de Bordeaux
    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 supportPHRC Nationnal 2011
    B.4.2CountryFrance
    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 Yes
    D.2.1.1.1Trade name GARDASIL
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
    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 in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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
    Infection by HPV 6, 11, 16, 18
    Infection par les papillomavirus humains (HPV) 6, 11, 16, 18
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    To evaluate the persistence of immunological response to tetravalent HPV vaccine at 18 months after first dose of vaccine
    Évaluer la réponse immunologique au vaccin anti-HPV tétravalent 18 mois après le début de la vaccination.
    E.2.2Secondary objectives of the trial
    - To study immunologic response at M7, M18, and M36
    - To study anti-HPV T cell response at M7 and M18
    - To describe frequency and distributions of HPV genotypes in the genital tractus
    - To evaluate the occurrence of clinical lesions (genital warts, cervical lesions)
    - To describe the frequency of adverse events
    - étudier la réponse immunologique à 7, 18, et 36 mois
    - décrire la réponse cellulaire T anti-HPV à M7 et M18
    - décrire la fréquence et la distribution de l’infection génitale par HPV
    - évaluer la survenue de lésions cliniques (condylomes, lésions cervicales)
    - évaluer la tolérance de la vaccination de M0 à M36.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female gender
    - Age ≥ 9 years
    - Solid organ transplantation: kidney, liver, heart, lung, intestinal or combined transplant; or systemic lupus erythematosus or other systemic immune disease
    - Transplantation or diagnosis of lupus since more than 6 months
    - Immunosuppressant treatment by anti-metabolites or calcineurin inhibitors, with or without associated corticosteroids
    - Minimum required period of 3 months considered as stable after transplantation or without relapse of lupus according to physician evaluation
    - In case of sexual activity (assessed by auto-declaration): onset less than one year before inclusion
    - Written informed consent signed by the investigator and the legal representatives of the patient, and assent by the patient
    - sexe féminin
    - âge supérieur ou égal à 9 ans
    - transplantation d’organe solide : rénale, hépatique, cardiaque, pulmonaire ou combinée ; ou lupus érythémateux disséminé ou autres maladie immune systémique
    - délai minimum de 6 mois après transplantation ou après diagnostic de lupus
    - traitement immunosuppresseur de type anti-métabolite ou anti-calcineurine avec ou sans corticothérapie associée
    - période minimale de stabilité : période de 3 mois considérée comme stable par le clinicien en post greffe ou sans poussée évolutive de la maladie selon l’évaluation du clinicien en cas de lupus
    - en cas d’activité sexuelle auto déclarée : début depuis moins d’un an
    - consentement libre, éclairé et écrit, signé par les deux représentants de l’autorité parentale, la patiente et l’investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par l’étude)
    E.4Principal exclusion criteria
    - Male gender
    - Pregnancy
    - Age < 9 years or > 18 years
    - Previous HPV vaccination
    - Immunosuppressive treatment by anti-TNF (adalimumab, etanercept, infliximab) or monoclonal antibodies (rituximab, anakinra, abatacept) during the last 3 months
    - Active malignancy
    - Active opportunistic infection
    - HIV infection
    - Concurrent clinical trial
    - sexe masculin
    - âge inférieur à 9 ans ou supérieur à 18 ans
    - vaccination anti-HPV préalable
    - pathologie tumorale active
    - infection opportuniste active
    - infection par le VIH
    - grossesse en cours
    - traitement immunosuppresseur de type anti-TNF (adalimumab, etanercept, infliximab) ou anticorps monoclonal (rituximab, anakinra, abatacept…) datant de moins de 3 mois
    - participation à un autre essai clinique
    E.5 End points
    E.5.1Primary end point(s)
    Seroconversion rate for HPV 16 and 18 at M18
    Proportion de séroconversion HPV dans les génotypes 16 et 18 à M18. La séroconversion sera définie en fonction d’un seuil de séropositivité des anticorps estimé à partir d’un seuil témoin de référence.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 month after first injection
    18 mois la première injection de vaccin
    E.5.2Secondary end point(s)
    Geometric means of anti-HPV 16 and 18 antibody titers at M7, M18, and M36, respectively.
    Proportion of patients with a good cell response at M7 and M18
    Number, type and time of occurrence of HPV genotypes 6, 11, 16, 18 in the genital tractus
    Proportion of patients with genital warts or cervical lesions (if relevant)
    Number, type and time of occurrence of adverse events of any grade between D0 and M36
    Les principaux critères de jugement secondaires sont les moyennes géométriques des titres d’anticorps anti-HPV 16 et 18 à M7, M18, et M36.
    Les autres critères de jugement secondaires sont :
    - la proportion de patientes avec une bonne réponse cellulaire T.
    - la fréquence et la distribution des génotypes 6, 11,16, 18
    - la fréquence des lésions génitales externes ou, en cas d’activité sexuelle déclarée, cervicales
    - le nombre, la nature et le délai de survenue des effets indésirables (quel que soit leur grade) de J0 à M36
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned13
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months48
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months48
    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: 35
    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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-01-05. Yes
    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 state35
    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 Decision2012-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-31
    P. End of Trial
    P.End of Trial StatusOngoing
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