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    The EU Clinical Trials Register currently displays   35419   clinical trials with a EudraCT protocol, of which   5814   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2007-002468-88
    Sponsor's Protocol Code Number:MRV02C
    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:2007-07-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-002468-88
    A.3Full title of the trial
    An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of a 2-dose regimen of ProQuad® manufactured with rHA administered to healthy children from 9 months of age
    A.4.1Sponsor's protocol code numberMRV02C
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur MSD SNC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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 nameProQuad® manufactured with rHA
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameMeasles virus1 Enders’ Edmonston strain (live attenuated)
    D.3.10 Strength
    D.3.10.1Concentration unit log10 TCID50 log10 tissue culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameMumps virus1 Jeryl Lynn™ (Level B) strain (live attenuated)
    D.3.10 Strength
    D.3.10.1Concentration unit log10 TCID50 log10 tissue culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameRubella virus2 Wistar RA 27or 3 strain (live attenuated)
    D.3.10 Strength
    D.3.10.1Concentration unit log10 TCID50 log10 tissue culture infective dose 50
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameVaricella virus3 Oka / Merck strain (live attenuated)
    D.3.10 Strength
    D.3.10.1Concentration unit log10 PFU log10 plaque forming unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.99
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Measles, mumps, rubella and varicella vaccine administered to healthy children from 9 months of age
    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
    The first primary objective is to demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy childrenof 11 months of age at the time of Dose 1 is as immunogenic as in healthy children of 12 months of age at the time of Dose 1, in terms of antibody response rates to measles, mumps, rubella and varicella at Day 42 following Dose 2.
    The second primary objective, only if the first primary objective is reached, is similar to the first one at 9 months of age.
    To demonstrate that a 2-dose regimen of ProQuad® rHA administered at a 3-month interval to healthy children of 11 months of age and 9 months of age at the time of Dose 1 is well tolerated compared to healthy children of 12 months of age at the time of Dose 1.
    E.2.2Secondary objectives of the trial
    To describe the antibody titres to measles, mumps, rubella and varicella at Day 42 following Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.

    To evaluate the safety profile of Dose 1 and Dose 2 of ProQuad® rHA administered to healthy children from 9 months of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy subject of either gender
    2. Subject 9 months of age [from the 9th month birthday to 1 day prior to the 10th month birthday, preferably the 2 first weeks after the 9th month birthday]
    3. Negative clinical history of measles, mumps, rubella, varicella or zoster
    4. Informed consent form signed by both parents or legal representative according to the local regulations
    5. Parent(s) or legal representative able to attend all scheduled visits with the subject and to understand and comply with the study procedures (i.e. able to read and write)
    6. Both parent(s) or legal representative over 18 years of age
    7. Subject affiliated to a health social security system.
    E.4Principal exclusion criteria
    1. Febrile illness in the previous 3 days (rectal temperature ³38.0°C) (a)
    2. Prior vaccination with a measles, mumps, rubella and/or varicella vaccine either alone or in any combination
    3. Exposure to measles, mumps, rubella, varicella and/or zoster in the previous 30 days(a)
    4. Tuberculin test done in the previous 2 days (a)
    5. Severe chronic disease
    6. Known active tuberculosis
    7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
    8. Hereditary problems of fructose intolerance
    9. Prior known sensitivity or allergy to any component of the vaccines including neomycin, sorbitol or gelatin, or true allergy to egg proteins (anaphylactic or anaphylactoid reaction after ingesting eggs)
    10. Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
    11. Humoral or cellular (primary or acquired) immunodeficiency, including hypogammaglobulinemia and dysgammaglobulinemia and AIDS, or symptomatic HIV infection
    12. Immunosuppressive therapy [including systemic corticosteroids(a), given daily or on alternate days at high doses (³2 mg/kg/day prednisone equivalent or ³20 mg/day if the subject's weight is >10 kg) during at least 14 days in the previous 30 days
    13. Family history of congenital or hereditary immunodeficiency
    14. Receipt of immunoglobulins or blood-derived products in the previous 150 days or scheduled to be administered through Visit 5
    15. Receipt of an inactivated vaccine within the previous 14 days (a)
    16. Receipt of a live non-study vaccine within the previous 28 days (a)
    17. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
    18. Current participation or scheduled participation in any other clinical study through Visit 5 (a).

    (a) Should a subject meet at least one of those criteria at Visit 1, inclusion will be postponed until this criteria is met, within the targeted age window. If the condition is not resolved within the targeted window, the subject should not be included.
    E.5 End points
    E.5.1Primary end point(s)
    The primary immunogenicity endpoints will be the antibody response rates to measles, mumps, rubella and varicella measured at Day 42 following Dose 2 (Blood sample 3).
    - The response rate for measles is the percentage of subjects with measles antibody titres ³255 mIU/mL.
    - The response rate for mumps is the percentage of subjects with mumps antibody titres ³10.0 ELISA Ab units/mL.
    - The response rate for rubella is the percentage of subjects with rubella antibody titres ³10.0 IU/mL.
    - The response rate for varicella is the percentage of subjects with varicella antibody titres ³5 gpELISA units/mL.
    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 Yes
    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
    Immunogenicity
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    The end of trial is defined as the last visit of the last subject.
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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.1.1.5Children (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 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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    minors (infants)
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1620
    F.4.2.2In the whole clinical trial 1620
    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 Decision2007-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
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