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    Summary
    EudraCT Number:2009-009602-10
    Sponsor's Protocol Code Number:P070164
    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:2009-04-03
    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 number2009-009602-10
    A.3Full title of the trial
    MICIVAX : Essai randomisé contrôlé contre placebo évaluant l’efficacité et la tolérance de la vaccination anti-grippale chez des patients traités par immunosuppresseurs pour une Maladie Inflammatoire Chronique Intestinale (MICI)
    A.4.1Sponsor's protocol code numberP070164
    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 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 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 Yes
    D.2.1.1.1Trade name Vaxigrip®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    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 nameVaxigrip®
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvirus grippal fragmenté et inactivé contenant des antigènes analogues aux souches suivantes voir RCP.
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MICI
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10021972
    E.1.2Term Maladie Inflammatoire Chronique Intestinale
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l'efficacité clinique de la vaccination anti-grippale dans une population de patients traitée par immunosuppresseurs pour une Maladie Inflammatoire Chronique Intestinale (MICI)
    E.2.2Secondary objectives of the trial
    -Evaluer et comparer le nombre de grippes confirmées virologiquement.
    -Evaluation de la morbidité et de la mortalité de la population de l'étude pendant la période épidémique
    -Evaluer la tolérance locale et générale de la vaccination.
    -Evaluer l'efficacité de la vaccination anti-grippale selon qu'elle est réalisée 1 fois ou lors de 2 années consécutives.
    -Rechercher les facteurs déterminants la réponse vaccinale anti-grippale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients ayant donné leur consentement de façon libre et éclairée.
    -Patient âgés de 18 à 64 ans
    -Patients suivis pour une maladie inflammatoire chronique intestinale (maladie de Chron, rectocolite hémorragique ou colite déterminée), et traités depuis au moins 3 mois par une traitement immunosuppresseurs, parmi lequel:
    Thiopurine (azathipurine, 6-mercaptopurine)
    Corticothérapie seule si cortcoïde supérieur ou égale à 10mg/jour équivalent prednisolone , ou corticothérapie quelle que soit la dose en cas d'association à un autre immunosuppresseur.
    Anti -TNF alpha
    Methotrexate
    Ciclosporine
    -Patients acceptant de participer à l'étude pendant toute sa durée et acceptant les procédures liées à l'étude ( carnet d'auto surveillance post-vaccinal, auto questionnaires, prélèvement nasal et suvi téléphonique)
    E.4Principal exclusion criteria
    ¢ Patients ayant une indication à la vaccination antigrippale d'après le calendrier vaccinal 2008 (avis du HCSP du 14 et 19 mars 2008), à l'exception du traitement immunosuppresseur pris dans le cadre de la MICI :
    " Personnes atteintes d'une des pathologies suivantes :
    - affection broncho-pulmonaire chronique ;
    - cardiopathie congénitale mal tolérée ; insuffisance cardiaque grave ; valvulopathie grave,
    - néphropathie chronique grave ; syndrome néphrotique pur et primitif ;
    - drépanocytose homozygotes et double hétérozygote S/C, thalassodrépanocytose,
    - diabète ne pouvant être équilibré par le régime seul,
    - déficit immunitaire cellulaire, autre que celui induit par les traitements immunosuppresseurs ou corticoïdes relatifs à la MICI
    " Personnes à risque d'exposition en milieu professionnel
    " Personne de l'entourage d'un nourrisson de moins de 6 mois présentant des facteurs de risque de grippe grave
    " Personnes séjournant dans un établissement de santé de moyen ou long séjour
    ¢ Patients ayant été vacciné contre la grippe dans les 6 mois précédant l'inclusion.
    ¢ Patients ayant présenté une allergie connue à l'un des composants du vaccin de l'étude ou une réaction d'hypersensibilité à la vaccination antigrippale
    ¢ Patients développant une maladie fébrile (au moins 37°5 C mesurée par voie orale) ou une infection aiguë dans la semaine précédant la vaccination.
    ¢ Patients en poussé de la maladie MICI le jour de la vaccination (score d'Harvey-Brasdshaw d'au moins 6 pour la maladie de Crohn ou score clinique de Mayo d'au moins 4 pour la RCH et la colite indéterminée)
    ¢ Test de grossesse urinaire B-HCG positif avant chaque vaccination de l'étude
    ¢ Patients ayant un antécédent connu de neuropathie évolutive ou de Guillain-Barré.
    ¢ Patients ayant une infection connue par le VIH et/ou par le VHB (antigène HBs positif) et/ou par le VHC.
    ¢ Patients présentant à l'inclusion une autre cause de déficit immunitaire sévère :
    " Déficit immunitaire congénital
    " Cancer ou hémopathie maligne évolutive
    " Chimiothérapie ou radiothérapie en cours
    " Cirrhose décompensée (Child-Plugh B ou C)
    " Transplantation d'organe ou greffe de moelle osseuse sous immunosuppresseurs
    ¢ Perfusions d'immunoglobulines, de produits dérivés du sang ou d'anticorps monoclonaux (à l'exception des anti-TNF) dans les 3 mois précédant la vaccination
    ¢ Patients institutionnalisé ou privé de liberté administrative ou judiciaire
    Non affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit)
    E.5 End points
    E.5.1Primary end point(s)
    Le critère principal d'évaluation sera le nombre de syndrôme gippaux ( température orale supérieure à 37.7°C , plus toux ou mal de gorge) survenus pendant la période épidémique plus ou moins une semaine telle que définie par le réseau Sentinelles ( INSERMU707). le syndrôme grippal correspond à la définition du CDC pour "illness-like influenza" ou ILI (cf protocole)
    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 Yes
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Plan factoriel 2x2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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 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.1.3Elderly (>=65 years) No
    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 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 2009-04-03. 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 state1400
    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 Decision2009-03-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-18
    P. End of Trial
    P.End of Trial StatusOngoing
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