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    Summary
    EudraCT Number:2011-006268-27
    Sponsor's Protocol Code Number:2011/199/HP
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-12
    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 number2011-006268-27
    A.3Full title of the trial
    Evaluation of the Immune Response against Neisseria meningitidis B:14,P1-7,16 in subjects inoculated by MenBVac (R) vaccine.
    Evaluation de la réponse immunitaire contre la souche de Neisseria Meningitidis B:14,P1.7,16 chez les sujets vaccinés par MenBVac®.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MenBVac vaccination efficiency
    Efficacité de la vaccination par MenBVac
    A.3.2Name or abbreviated title of the trial where available
    MenBVac clinical trial extension
    Extension de l'étude MenBVac
    A.4.1Sponsor's protocol code number2011/199/HP
    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 - Hôpitaux de Rouen
    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 supportDirection Générale de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU - Hôpitaux de Rouen
    B.5.2Functional name of contact pointClinical Research Associate
    B.5.3 Address:
    B.5.3.1Street Address1 rue de Germont
    B.5.3.2Town/ cityROUEN
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.5Fax number+33232888287
    B.5.6E-mailSecretariat.DRC@chu-rouen.fr
    D. IMP Identification
    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
    Immunogenic Study, in french children living in the region of Normandy, France, after vaccination for B:14,P1-7,16 bacterial strain.
    Etude d'immunogéneïcité menée chez des enfants de la zone de Dieppe, afin de connaître la persistance à plus long terme des anticorps contre la souche B:14,P1-7,16.
    E.1.1.1Medical condition in easily understood language
    Vaccination efficiency
    Efficacité vaccinale
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10027203
    E.1.2Term Meningeal bacterial infections
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of French children living in the region of Normandy, France, after vaccination for B:14,P1-7,16, with hSBA level > 4, 2 years and 6 months after inoculation.
    L'objectif est de mesurer le pourcentage d'enfants présentant un titre hSBA >= 4, 2ans et demi après le début de vaccination.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Enfants ayant participés à l'étude MenBvac (2007/004/HP – n°EudraCT 2007-000298-49) ; 2) Enfant ayant terminé leur schéma vaccinal (2+1+1) en mai 2008 ;3) Consentement éclairé delivré par le(s) titulaire(s) de l'autorité parentale.
    E.4Principal exclusion criteria
    1) Absence de consentement éclairé delivré par le(s) titulaire(s) de l'autorité parentale ; 2) Impossibilité de réaliser le prélèvement sanguin ; 3) Enfant sous tutelle ou curatelle.
    E.5 End points
    E.5.1Primary end point(s)
    hSBA level
    Titrage du hSBA
    E.5.1.1Timepoint(s) of evaluation of this end point
    January 2012
    Janvier 2012
    E.5.2Secondary end point(s)
    none
    aucun
    E.5.2.1Timepoint(s) of evaluation of this end point
    none
    aucun
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 No
    E.8.1.2Open No
    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 No
    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 months
    E.8.9.1In the Member State concerned days
    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: 235
    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.1.1.5.1Number of subjects for this age range: 235
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    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 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 state235
    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)
    not applicable
    non applicable
    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 Decision2012-01-03
    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 StatusCompleted
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