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    Summary
    EudraCT Number:2016-001104-36
    Sponsor's Protocol Code Number:IIV-291
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-23
    Trial results View 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 number2016-001104-36
    A.3Full title of the trial
    Immunogenicity and safety study of a third measles mumps rubella (MMR-3) vaccine dose in healthy young adults in The Netherlands
    Onderzoek naar de immunogeniciteit en veiligheid van een derde vaccinatie met het bof, mazelen, rubella combinatievaccin (BMR-3) bij gezonde jongvolwassenen in Nederland
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MMR-3 research; The effect of a third vaccination with the mumps, measles and rubella combination vaccine on the immunity against the mumps virus in healthy young adults.
    BMR-3 onderzoek: Het effect van een derde vaccinatie met het bof, mazelen en rodehond combinatievaccin op de afweer tegen het bofvirus bij gezonde jongvolwassenen
    A.3.2Name or abbreviated title of the trial where available
    Third MMR vaccine dose in young adults (acronym: MMR-3)
    Derde BMR-3 vaccinatie in jongvolwassenen (BMR-3)
    A.4.1Sponsor's protocol code numberIIV-291
    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 supportRIVM
    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 pointClinical Expertise Centre
    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.5.6E-mailmensgebonden-onderzoek@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
    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
    immunological response to an extra mumps immunization (in healthy volunteers)
    immunologische reactie op een extra bof vaccinatie (in gezonde vrijwilligers)
    E.1.1.1Medical condition in easily understood language
    Mumps immunization
    Bof 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 third dose of MMR in young adults 18-25 years of age on the development of mumps-specific serum VN antibody titers (against vaccine- and currently circulating wild-type mumps virus strains (genotype G)) and mumps-specific serum antibody IgG titers (including antibody avidity), 10 days, 4 weeks , 1 year and 3 years following vaccination
    Bepalen van het effect van een derde BMR vaccinatie in jong volwassenen 18-25 jaar op de ontwikkeling van bof specifieke virus neutralisatie antistof titers (tegen vaccin en huidig circulerende wild type bof virus stammen (genotype G)) en bof specifieke serum antistof IgG titers (inclusief antistof aviditeit), 10 dagen, 4 weken, 1 jaar en 3 jaar na vaccinatie.
    E.2.2Secondary objectives of the trial
    To assess the local and systemic tolerance of a third dose of MMR.
    To assess the short- and long-term (4 weeks and 1 year) mumps-specific IgA and IgG (in saliva) following a third dose of MMR.
    To explore the short- and long-term (4 weeks and 1 year) mumps-specific cell-mediated responses, i.e. presence and frequency of mumps-specific memory and effector T- and B-cells following a third dose of MMR.
    To assess the short- and long-term (10 days, 4 weeks, 1 year and 3 years) IgG response against measles and rubella (components of the MMR vaccine) following a third dose of MMR.
    Bepalen van lokale en systemische tolerantie van een derde dosis van BMR.
    Bepalen van korte en lange termijn (4 weken en 1 jaar) bof specifieke IgA en IgG (in speeksel) na een derde dosis BMR.
    Onderzoeken van de korte en lange termijn bof specifieke cel gemedieerde reactie, zoals, aanwezigheid en frequentie van bof-specifieke geheugen en effector T- en B-cellen, volgend op een derde BMR vaccinatie.
    Bepalen van korte en lange termijn (10 dagen, 4 weken, 1 jaar en 3 jaar) IgG reactie tegen mazelen en rode hond (componenten van het BMR vaccine) na een derde BMR vaccinatie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy young adult 18-25 years of age.
    Previously been immunized with two doses of the MMR vaccine according to the Dutch NIP (MMR-1 at ~14 months and MMR-2 at ~9 years).
    Gezonde jong volwassene 18-25 jaar oud.
    In het verleden gevaccineerd met 2 dosis BMR vaccin volgens het Nederlandse Rijksvaccinatie Programma (BMR op ~14 maanden en ~9 jaar).
    E.4Principal exclusion criteria
    Medical conditions that will severely affect immunological responses to vaccinations, such as, but not limited to, cancer or an immune disorder.
    Vaccination should be postponed during any illness with fever >38.5°C until the fever has disappeared.
    Vaccination with any vaccine during the first two weeks before and four weeks after MMR-3.
    An additional MMR vaccination during the study.
    Coagulation disorder and/or anticoagulant medication.
    Be or have been under immunosuppressive medical treatment, like cytostatics, high-dose corticosteroids, immune globulins, blood or plasma transfusions that might interfere with the results of the study (within the previous 3 months).
    Have or previously had clinical symptoms of mumps virus infection.
    Have or previously had cases of mumps disease within your Household.
    Had experienced a previous severe adverse reaction to any vaccine.
    Being pregnant; Furthermore, pregnancy should be avoided for 1 month following vaccination.
    Breast-feeding women.
    Medische aandoening die de immunologische reactie op vaccinatie ernstig beïnvloed, zoals, maar niet exclusief, kanker of een immuun ziekte.
    Vaccinatie moet uitgesteld worden tijdens een ziekte met koorts >38.5°C, totdat de koorts is verdwenen.
    Vaccinatie met ieder vaccin tijdens de 2 weken voor en 4 weken na BMR-3.
    Extra BMR vaccinatie tijdens de studie.
    Bloedingsziekte en/of antistolling medicatie.
    Immuniteit onderdrukkende medicatie, zoals cytostatica, hoge dosis corticosteroïden, immuunglobuline, bloed of plasma transfusies die de resultaten van de studie kunnen beïnvloeden (nu en in de laatste 3 maanden).
    Klinische symptomen van bof (nu of in het verleden).
    Bof infecties in het huishouden (nu of in het verleden).
    In het verleden doorgemaakte ernstige reactie op een vaccin.
    Zwangerschap; ook moet zwangerschap worden vermeden in de maand na vaccinatie.
    Borstvoeding geven.
    E.5 End points
    E.5.1Primary end point(s)
    1. Mumps-specific VN antibody titers (against the vaccine and currently circulating mumps virus strains) and IgG antibody titers (including antibody avidity) measured in serum samples following a third vaccine dose of MMR in healthy young adults (18-25 years).
    1. Bof specifieke virus neutraliserende antistof titers (tegen vaccin en huidig circulerende bof virus stammen) en IgG antistof titers (inclusief antistof aviditeit) gemeten in serum monsters na de derde BMR vaccinatie in gezonde jong volwassenen (18-25 jaar).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. prior to and 10 days, 4 weeks , 1 year and 3 years following a third vaccine dose of MMR.
    1. net voor, 10 dagen, 4 weken, 1 jaar en 3 jaar na de derde BMR vaccinatie.
    E.5.2Secondary end point(s)
    2. Frequency and intensity of the local and systemic tolerance.
    3. Mumps-specific IgA and IgG (saliva*) following a third vaccine dose of MMR.
    4. The presence and frequency of mumps-specific memory and effector T- and B-cells in peripheral blood following MMR-3, in a voluntary subset of the participants.
    5. Serum IgG response against measles and rubella (components of the MMR vaccine) following a third vaccine dose of MMR.
    2. Frequentie en intensiteit van lokale en systemische reacties.
    3. Bof specifieke IgA en IgG (speeksel*) na een derde BMR vaccinatie.
    4. Aanwezigheid en frequentie van bof specifieke geheugen en effector T en B cellen in perifeer bloed na BMR-3 in een vrijwillige subset van de deelnemers.
    5. Serum IgG reactie tegen mazelen en rode hond (componenten van de BMR vaccinatie) na BMR-3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2. 0-14 days post vaccination.
    3. Prior to and 10 days, 4 weeks and 1 year following a third vaccine dose of MMR.
    4. Prior to, 4 weeks and 1 year following a third vaccine dose of MMR.
    5. Prior to and 10 days, 4 weeks, 1 year en 3 years following a third vaccine dose of MMR.
    *Saliva not collected at 10 days following immunisation
    2. 0-14 dagen na vaccinatie.
    3. net voor en 10 dagen, 4 weken en 1 jaar na BMR-3 vaccinatie.
    4. net voor, 4 weken en 1 jaar na BMR-3 vaccinatie.
    5. net voor en 10 dagen, 4 weken, 1 jaar en 3 jaar na BMR-3 vaccinatie.
    *Speeksel is niet verzameld op 10 dagen na vaccinatie.
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 visite laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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.1.2.1Number of subjects for this age range: 150
    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 state150
    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 Decision2016-05-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-03-25
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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