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    Summary
    EudraCT Number:2014-001538-28
    Sponsor's Protocol Code Number:P130930
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-06-26
    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 number2014-001538-28
    A.3Full title of the trial
    Recherche de l’excrétion du virus vaccinal de la rougeole dans le lait de femmes vaccinées en postpartum par un vaccin trivalent Rougeole-Rubéole-Oreillons(RRO)
    A.3.2Name or abbreviated title of the trial where available
    BREMEAVAC
    A.4.1Sponsor's protocol code numberP130930
    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 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 PRIORIX
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    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 namePRIORIX
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNvirus vivants atténués Rougeole-Oreillons-Rubéole
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Femmes enceintes rubéole négative et rougeole négative
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10070264
    E.1.2Term Measles virus test positive
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Détection de l'excrétion de la souche vaccinale du virus de la rougeole dans le lait de femmes allaitantes ayant des sérologies rougeole et rubéole négatives, après vaccination en postpartum par un vaccin trivalent Rougeole-Oreillons-Rubéole (ROR)
    E.2.2Secondary objectives of the trial
    1/ Evaluer l'impact clinique de la vaccination ROR sur l'enfant allaité.
    2/ Evaluer l'impact immunologique de la vaccination ROR sur l'enfant allaité.
    3/ Détecter l'excrétion de la souche vaccinale du virus de la rougeole dans les urines des femmes allaitantes
    En cas de détection de l'excrétion de la souche vaccinale du virus de la rougeole dans le lait:
    4/ Quantification de la souche vaccinale du virus de la rougeole dans le lait maternel
    5/ Evaluation de l'infectiosité de la souche vaccinale du virus de la rougeole dans le lait maternel
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Mère:
    1.Femme enceinte
    2.Âgée de >ou = 18 ans et nées après 1980
    3.Planifiant d'allaiter son enfant pendant au moins 8 semaines (l'allaitement mixte est autorisé)
    4.Ayant eu une sérologie rubéole négative durant sa grossesse
    5.Sérologie rougeole négative basée sur le résultat d'une analyse réalisée dans le laboratoire de routine de l'hôpital
    6.Affiliée à un régime de sécurité social

    Enfant:
    1.Formulaire de consentement éclairé signé par la ou les personnes détenant l'autorité parentale.
    2.Nouveau-né né à terme (>ou =37SA)
    E.4Principal exclusion criteria
    Mère:
    1.Femme ayant une grossesse multiple
    2.Femme planifiant de tomber enceinte dans le mois suivant la 2ième vaccination
    3.Femme ayant une infection VIH connue ou suspectée
    4.Femme ayant une immunodéficience connue ou suspectée
    5.Femme ayant des antécédents familiaux de déficit immunitaire héréditaire
    6.Femme ne maîtrisant pas assez la lecture et la compréhension de la langue française pour être capable de consentir de participer à l'étude.
    7.Femme incapable de suivre les procédures de l'étude et de respecter les visites durant toute la période de l'étude.
    8.Femme ayant une contre-indication pour la vaccination ROR :
    o Problème héréditaire rare d'intolérance au fructose
    o Femme ayant des antécédents d'hypersensibilité aux substances actives ou à un des excipients composant le vaccin.
    o Administration de gammaglobuline humaine dans les trois dernier mois
    o Transfusion sanguine dans les trois derniers mois
    o Maladie fébrile sévère aiguë dans les 7 jours précédant l'injection.
    9.Femme sous corticostéroïde systémique (prednisone ou équivalent ?10 mg/jour) dans les 15 jours précédant ou planifiant de prendre des corticostéroïdes (i.e. prednisone ou équivalent ?10 mg/jour) pendant les 15 jours suivant la vaccination.
    10.Femme sous traitement immunosuppresseur (excepté le Rhophylac®) durant les trois mois précédant la vaccination ou planifiant de suivre un traitement immunosuppresseur dans les 15 jours suivant la vaccination.
    11.Femme participant à un essai clinique avec un autre produit expérimental dans les 28 jours précédant la visite V0, ou ayant l'intention de participer à un autre essai clinique avec un autre produit expérimental à tout moment au cours de la réalisation de cette étude.
    12.Tout autre raison qui, selon l'investigateur, pourrait interférer avec l'évaluation des objectifs de l'étude.

    Enfant:
    1.Prélèvement sanguin contre-indiqué ou ne pouvant être réalisé
    2.Enfant ayant des antécédents familiaux de déficit immunitaire héréditaire
    3.Enfant ayant une immunodéficience connue ou suspectée
    4.Tout autre raison qui, selon l'investigateur, pourrait interférer avec l'évaluation des objectifs de l'étude.
    E.5 End points
    E.5.1Primary end point(s)
    Nombre de sujets ayant une RT-PCR positive pour la souche vaccinale du virus de la rougeole dans au moins un échantillon de lait maternel. recueilli à J7, J11 et J14. La RT-PCR sera considérée positive, si la mesure dépasse la limite de détection de 10 copies de génome de la souche vaccinale du virus de la rougeole par réaction.
    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 No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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 months0
    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 Yes
    F.1.1Number of subjects for this age range: 70
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 70
    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 No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state250
    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 Decision2015-02-02
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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