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    Summary
    EudraCT Number:2006-000732-28
    Sponsor's Protocol Code Number:M14P5E1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-13
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-000732-28
    A.3Full title of the trial
    A Phase IV, Single Centre, Open-label Study to Investigate the Kinetics of the B Cell Response to the C saccharide component of Chiron’s Meningococcal C Conjugate Vaccine (Menjugate®) Administered to Healthy Children at least 12 Months of Age After Priming with Menjugate® at 2, 3 and 4 Months of Age.
    A.4.1Sponsor's protocol code numberM14P5E1
    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 SponsorChiron S.r.l.
    B.1.3.4CountryItaly
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameN.meningitidis serogroup C (strain C11) oligosaccharide conjugated to C diphtheriae CRM197 protein
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 subjects without known medical conditions will be vaccinated against Neisseria meningitidis serogroup C. Active prevention of meningococcal C disease caused by Neisseria meningitidis serogroup C.
    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 establish whether memory B cells persist in the blood at least one year after primary immunisation with Menjugate® at 2, 3 and 4 months of age as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.

    To establish at which day meningococcal C specific B cells are detectable in the blood of healthy children after a booster immunisation with Menjugate®, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.

    To determine the immune response to Menjugate®, as determined by Neisseria meningitidis serogroup C specific serum bactericidal activity using human complement (hSBA) or baby rabbit complement (rSBA) measured 4 weeks after the booster immunisation.
    E.2.2Secondary objectives of the trial
    Persistence of the immune response to a primary course of Menjugate®, as determined by analysis of N. meningitidis serogroup C specific ELISA on serum obtained prior to the booster immunisation; Kinetics of the immune response to a booster dose of Menjugate®, as determined by analysis of N. meningitidis serogroup C specific ELISA on serum obtained at variable times in the week following the booster immunisation; Persistence of the immune response to a primary course of Menjugate®, as determined by analysis of serum obtained prior to the booster immunisation for N. meningitidis serogroup C specific hSBA; Immune response to Menjugate®, as determined by N. meningitidis serogroup C specific ELISA measured 4 weeks after the booster immunisation; To establish at which day CRM -197 specific B cells are detectable in the blood of healthy children after a booster immunisation with Menjugate®, as determined by CRM -197 specific B-cell ELISpot assay or limiting dilution
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. healthy children aged 12-13 months (inclusive) who took part in the previous study to establish the kinetics of the B cell response to MenC vaccine at 2, 3 and 4 months (study M14P5, Eudract number 2004-004962-33)

    2. available for the visits scheduled in the study;

    3. in good health as determined by:
    - medical history
    - clinical judgment of the investigator
    - pre-vaccination check performed by a physician if indicated by medical history

    4. whose parents can give written informed consent for the child to be enrolled in the study.

    Informed consent must be obtained for all subjects before enrolment into the study.
    E.4Principal exclusion criteria
    1. Children whose parents have not given or are unwilling or unable to give written informed consent to their child’s participation in the study

    2. Known hypersensitivity to any vaccines or constituents

    3. Unacceptable concurrent illnesses or conditions - children
    a. with a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;
    b. with a genetic anomaly;
    c. with any immunodeficiency, including use of systemic corticosteroids
    d. with previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease;
    e. with a known bleeding diathesis, or any condition associated with a prolonged bleeding time;

    4. Prohibited prior or concomitant medications
    a. Any immunizations, with the exception of those received in the initial phase of the study, BCG, hepatitis B or Hib;
    b. Receipt of immunoglobulin;
    c. Receipt of any blood products;

    5. Participation in any other clinical trial either currently or in the previous month;

    6. Inability to adhere to the protocol, including plans to move from the area;

    7. Other
    With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    To establish whether memory B cells persist in the blood at least one year after primary immunisation with Menjugate® at 2, 3 and 4 months of age as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.

    To establish at which day meningococcal C specific B cells are detectable in the blood of healthy children after a booster immunisation with Menjugate®, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution.

    To determine the immune response to Menjugate determined by Neisseria menigitidis serogroup C specific hSBA or rSBA and ELISA measured 4 weeks after the booster immunisation.
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Characterise immune response, specifically B cell response prior to and after booster with Menjugate
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    Last Subject, Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children 12-13 months. Concent is given by parents or legal guardians
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state72
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 72
    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 Decision2006-03-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-10
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