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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2014-001538-28
    Sponsor's Protocol Code Number:P130930
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-03
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-001538-28
    A.3Full title of the trial
    Search for the measles vaccine virus excretion in breast milk of breastfeeding women after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine
    Recherche de l’excrétion du virus vaccinal de la rougeole dans le lait de femmes vaccinées en postpartum par un vaccin trivalent Rougeole-Oreillons-Rubéole (ROR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To look for the measles vaccine in breast milk of breastfeading women, vaccinated after delivery by measles-mumps-rubella (MMR) vaccine
    Recherche du vaccin de la rougeole dans le lait de femmes allaitantes, vaccinées après l'accouchement par un vaccin Rougeole-Oreillons-Rubéole (ROR)
    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
    Pregnant women, rubella negatives and measles negatives
    Femmes enceintes rubéole négative et rougeole négative
    E.1.1.1Medical condition in easily understood language
    Pregnant women, rubella negatives and measles negatives
    Femmes enceintes rubéole négative et rougeole négative
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    Detection of measles vaccine strain excretion in breast milk of breastfeeding women, with negative rubella and measles serologies, after postpartum vaccination with a combined measles-mumps-rubella (MMR) vaccine
    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/ Evaluate the clinical impact of MMR vaccination in breastfeeding infant.
    2/ Evaluate the immunological impact of MMR vaccination in breastfeeding infant.
    3/ Detection of measles vaccine strain excretion in urine of breastfeeding women

    In case of detection of measles vaccine virus strain excretion in breast milk:
    4/ Quantification of the measles vaccine virus strain in breast milk
    5/ Evaluate the infectious activity of the measles vaccine virus in breast milk
    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
    Women:
    1. Pregnant woman
    2. Age ≥ 18 years
    3. Planning to breastfeed her infant (mixed feeding is allowed)
    4. Having a negative serology for rubella during pregnancy
    5. Negative serology for measles based on the result from local laboratory
    6. Affiliated to a social security regimen (applicable only for France)

    Infants:
    1. Informed consent form signed by the person(s) holding parental authority.
    2. Born after 36LPM (≥36LPM)
    Mère:
    1.Femme enceinte
    2.Âgée de >ou = 18 ans
    3.Planifiant d'allaiter son enfant (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 (applicable seulement pour la France)

    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
    Women:
    1. Woman having a multiple pregnancy
    2. Woman planning to get pregnant in the month following the 2nd vaccination
    3. Woman with known or suspected HIV infection
    4. Woman with known or suspected immunodeficiency
    5. Woman with family history of hereditary immune deficiency
    6. Woman not mastering enough the reading / understanding of the French language to be able to consent to participate to the study
    7. Woman incapable to follow the procedures of the study and to respect study visits for the whole period of the study.
    8. Woman with contraindication for MMR vaccination:
    o Scarce hereditary problems of fructose intolerance
    o Woman with history of hypersensitivity to the active substances or to any of the excipients of the vaccine
    o Administration of human gammaglobulins in the past 3 to 11 months depending on the dose of human globulins administered (except for Rhophylac®)
    o Blood transfusion in the past 3 months
    o Acute severe febrile illness within 7 days prior to injection
    9. Woman under systemic corticosteroids (prednisone, or equivalent ≥10 mg/day) within the previous 15 days or planning to use corticosteroids (i.e. prednisone, or equivalent ≥10 mg/day) during the 15 days following vaccination
    10. Woman under immunosuppressive therapy within the previous 3 months before vaccination or planning to use immunosuppressive therapy during the 15 days following vaccination
    11. Woman participating in any clinical trial with another investigational product 28 days prior to visit V0 or intent to participate in another clinical study with another investigational product at any time during the conduct of this study
    12. Any other reason which, according to the investigator, may interfere with the evaluation of the study objectives
    13. Woman with documented history of measles vaccination (1 or 2 doses) and/or history of documented measles

    Infants:
    1. Blood draw is contraindicated or cannot be performed
    2. Infant with family history of hereditary immune deficiency and/or suspected or confirmed immunodeficiency
    3. Any other reason which, according to the investigator, may interfere with the evaluation of the study objectives

    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 gammaglobulines humaines dans les 3 à 11 derniers mois selon la dose de globulines humaines administrée (excepté pour Rhophylac)
    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 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.
    13. Femmes ayant des antécédents documentés de vaccination rougeole (1 ou 2 doses) et/ou antécédent de rougeole documenté

    Enfant:
    1.Prélèvement sanguin contre-indiqué ou ne pouvant être réalisé
    2.Enfant ayant des antécédents familiaux de déficit immunitaire héréditaire et/ou une immunodéficience connue ou suspectée
    3.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)
    Number of subject with positive RT-PCR for measles vaccine virus strain in breast milk for at least one sample from day 7, 11 and 14. RT PCR will be considered positive if the measurements exceed the limit of detection of 10 copies of genome per reaction
    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.5.1.1Timepoint(s) of evaluation of this end point
    V0 (first day of vaccine administration), V0 + 7 days, V0 + 11 days, V0 + 14 days
    E.5.2Secondary end point(s)
    1/
    a) Number of infant with reported clinical symptoms of measles:
    - at week 8 (V1)
    - from data reported in the infant diary card between visit V0 and visit V1.
    b) Number of woman with reported clinical symptoms of measles.
    2/ Number of infant with positive measles serology (IgM) at week 8 (V1).
    3/ Number of woman with positive RT-PCR for measles vaccine virus strain in urine, in at least one of the following samples: day 7, 11 and 14.

    In case of detection of measles vaccine virus strain excretion in breast milk :
    4/ Measles vaccine strain will be quantitatively measured in breast milk by RT PCR.
    5/ Measles vaccine virus strain multiplication will be measured in cell culture : all samples in which a RT-PCR signal is detected will be submitted to an in vitro infectivity assay. A result is considered as positive when at least one positive fluorescent cell is detected.
    E.5.2.1Timepoint(s) of evaluation of this end point
    V0 (first day of vaccine administration), V0 + 7 days, V0 + 11 days, V0 + 14 days, V0 + 8 weeks
    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
    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 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.1.2.1Number of subjects for this age range: 70
    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
    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 Decision2015-12-24
    N.Ethics Committee Opinion of the trial applicationWithdrawn
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-03
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