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    Summary
    EudraCT Number:2013-003078-28
    Sponsor's Protocol Code Number:IIV-273
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-08-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-003078-28
    A.3Full title of the trial
    Immunological effect of early extra MMR immunization in infants between 6 and 12 months of age in an outbreak setting
    Immunologisch effect van een vroege extra BMR vaccinatie in zuigelingen tussen 6 en 12 maanden oud tijdens een uitbraak
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunological effect of early extra MMR immunization
    Immunologisch effect van een vroege extra BMR vaccinatie
    A.3.2Name or abbreviated title of the trial where available
    Immunological effect of early extra MMR immunization (EMI)
    Immunologisch effect van een vroege extra BMR vaccinatie (EMI)
    A.4.1Sponsor's protocol code numberIIV-273
    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 SponsorRIVM
    B.1.3.4CountryNetherlands
    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 supportMinistry of VWS
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRIVM
    B.5.2Functional name of contact pointEMI study information
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 1
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720 BA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031302743299
    B.5.6E-mailBMR-nul-EMI@rivm.nl
    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 M-M-RVAXPRO
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD, SNC
    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 Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    Subcutaneous use
    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 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 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.IMP: 2
    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 NeisVac-C
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Ltd
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 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 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
    healthy volunteer
    (immunological response to early extra measles immunization)
    gezonde vrijwilliger (immuun response op vroege extra mazelen vaccinatie)
    E.1.1.1Medical condition in easily understood language
    Measles immunization
    Mazelen vaccinatie
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 assess the effect of an early extra measles immunization between 6 and 12 months of age on the development of humoral and cell-mediated immunity against measles following routine MMR immunization at 14 months of age.
    Effect bepalen van vroege extra mazelen vaccinatie (gegeven tussen 6-12 maanden leeftijd) op humorale en cellulaire immuun response tegen mazelen volgend op de routine BMR vaccinatie gegeven op 14 maanden leeftijd
    E.2.2Secondary objectives of the trial
    Determine effect of early extra measles immunization on the immunogenicity against other infant vaccines of the NIP

    Determine the influence of maternal measles antibodies on the infants’ immune response to measles immunization

    Determine the rate of measles (neutralizing) antibody decline between 6 weeks and 1 year after routine MMR immunization at 14 months of age
    Bepalen van effect van vroege extra mazelen vaccinatie op de immuniteit van de andere kindervaccinaties in het Rijksvaccinatie Programma

    Bepalen van de invloed van maternale mazelen antistoffen op de immuunreactie van het kind op de mazelen vaccinatie

    Bepalen van de snelheid van afname van (neutraliserende) mazelen antistoffen tussen 6 weken en 1 jaar na de routine BMR-1 vaccinatie op 14 maanden leeftijd
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1: infants receiving (or having received) MMR-0 between 6-12 months of age and who are about to receive the MMR-1 at 14 months of age

    Group 2: infants not receiving MMR-0 and who are about to receive the MMR-1 at 14 months of age
    Groep 1: kinderen die BMR-0 ontvangen of gaan ontvangen tussen de leeftijd van 6-12 maanden en die BMR-1 gaan ontvangen op 14 maanden leeftijd

    Groep 2: kinderen die geen BMR-0 ontvangen en die wel de BMR-1 gaan ontvangen op 14 maanden leeftijd
    E.4Principal exclusion criteria
    Encountered measles infection earlier in life

    Receiving immunosuppressive medication

    Presence of a serious disease that requires medical care that can interfere with the results of the study

    Known or expected allergy/hypersensitivity against one of the vaccine ingredients

    Known or suspected immunological disorder

    Bleeding disorders
    Doorgemaakte mazelen infectie

    Ontvangen van immuunsuppresieve medicatie

    Aanwezigheid van een ernstige ziekte die medische zorg vereist die de resultaten van de studie kan beinvloeden

    Bekende of vermoedd allergie of overgevoeligheid tegen een van de vaccin componenten

    bekende of vermoede immunologische ziekte

    bloedingsziekte
    E.5 End points
    E.5.1Primary end point(s)
    Measles specific B- and T-cell immunogenicity

    Measles specific serum IgG antibody concentrations, avidity (Luminex), and functional antibody characteristics with plaque neutralisation (PRN)
    Mazelen specifieke B- en T-cell

    Mazelen specifieke serum IgG antistof concentraties, aviditeit (Luminex) en functionele antistoffen met plaque neutralisatie (PRN)
    E.5.1.1Timepoint(s) of evaluation of this end point
    immediately before and 7-9 days, 6 weeks and one year post MMR-1
    direct voor en 7-9 dagen, 6 weken en 1 jaar na BMR-1
    E.5.2Secondary end point(s)
    Serum IgG antibody concentrations against other vaccines of the NIP (mumps, rubella, MenC, diphtheria, tetanus, pertussis antigens (Ptx, FHA and PRN), Hib, HepB, and pneumococcal serotypes present in PCV10 (Luminex)

    Measles, mumps and rubella antibody concentrations in DBS collected at 6 days of age, to monitor the concentrations of maternal antibodies delivered at birth (and to predict the concentrations at the time of MMR-0)
    Serum IgG antistof concentraties tegen andere RVP vaccines (bof, rode hond, MenC, difterie, tetanus, kinkhoest (Ptx, FHA en PRN), Hib, HepB en pneumokokken serotypen in PCV10 (Luminex)

    Mazelen, bof en rode hond antistof concentraties in droge bloed spots op de hielprik kaartjes die zijn verzameld op de leeftijd van 6 dagen, om de concentraties van maternale antistoffen die bij geboorte zijn meegegeven te bepalen (en om de concentraties op het tijdstip van BMR-0 te voorspellen)
    E.5.2.1Timepoint(s) of evaluation of this end point
    immediately before and 7-9 days, 6 weeks and one year post MMR-1
    direct voor en 7-9 dagen, 6 weken en 1 jaar na BMR-1
    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 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 Yes
    E.6.13.1Other scope of the trial description
    immune response to early extra measles vaccination
    immuun reactie op vroege extra mazelen vaccinatie
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    kinderen die geen vroege extra BMR-0 vaccinatie hebben gehad
    children who have not received the extra early MMR-0 immunization
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    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
    LVLS
    Laatste bezoek laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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: 100
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 100
    F.1.1.5Children (2-11years) No
    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 state100
    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
    Geen
    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 Decision2013-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-22
    P. End of Trial
    P.End of Trial StatusOngoing
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