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    Summary
    EudraCT Number:2005-000924-18
    Sponsor's Protocol Code Number:M14P6
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-04-06
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-000924-18
    A.3Full title of the trial
    A Phase III, Multi-Center, Open-Label, Controlled, Randomized Study to Evaluate the Immunogenicity, Safety, Tolerability and the Ability to Prime for Memory of Chiron Meningococcal C Conjugate Vaccine Menjugate® When Administered to Healthy Infants as One Dose Given at 2 or 6 Months of Age with a Booster at 12-16 Months of Age, in Comparison to Two Doses in the First Year of Life, Given Two Months Apart, With a Booster at 12-16 Months of Age;
    A.4.1Sponsor's protocol code numberM14P6
    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 SponsorNovartis Vaccines and Diagnostics 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 Yes
    D.2.1.1.1Trade name Menjugate Kit
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics S.r.l
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameMenjugate
    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 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 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 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 subjects without known medical conditions will be vaccinated against N. menigitidis serogroup C. Active prevention of menigococcal C disease caused by Neisseria menigitidis
    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 demonstrate non-inferiority, 10 days after the booster vaccination, of the memory antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (study group 2) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (study group 1), as measured by bactericidal assay using rabbit complement (rBCA).
    E.2.2Secondary objectives of the trial
    -Compare the memory response (% responders) in group 3 with the memory response in study group 1.
    -Compare the memory response group 1, with the antibody response elicited after 1 dose given in the 2nd year of life.
    -Evaluate the response 1 month after 1 dose of Menjugate at 2 or 6 months of age.
    Compare the response 1 month after 1 dose of Menjugate at either 2 or 6 months of age with the antibody response 1 month after 2 doses at 2 and 4 months of age.
    -Evaluate the persistence of the response in study groups 1 to 3 and the persistence of antibody response after 2 doses at 2 and 4 months of age, before the administration of the booster at ≥8 to ≤10, 12-16, and at 24 months of age after booster vaccination.
    -Evaluate the memory response after 1 dose of Menjugate at either 2 or 6 months of age plus a booster dose in the 2nd year of life.
    -Evaluate the imm. response of hexavalent vaccine components with priority on H.influenzae type B, when concomitantly given with Menjugate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy infants (7 to 11 weeks of age), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;

    for whom the parents/legal guardians have given written informed consent after the nature of the study has been explained;

    who are available for all the visits scheduled in the study;
    E.4Principal exclusion criteria
    Whose parents/legal guardians are unwilling or unable to give written informed consent to their child’s participation in the study;

    Who previously received Meningococcal C vaccine of any kind;

    Who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, history of microbiologically proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping;

    Who have had household contact with and/or intimate exposure to an individual with microbiologically proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days;

    Who have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 60 days prior to enrolment, through to 30 days following any study vaccine administration; except for the vaccination against Tuberculosis which is allowed to be given to the subjects in the Polish sites since this is a legally required infant vaccination in Poland given to the child at birth and except for the Hepatitis B vaccination given in Poland at birth as well and except for vaccination with DTaP-IPV-HBV/Hib, which as routine infant vaccination is allowed to be given concomitantly to the study medication as indicated in the time and events table above.

    Who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;

    Who received prior vaccination with DTaP-IPV-HBV/Hib or any of the components (before the age of 2 months), unless the exception for Hepatitis B in Poland applies;

    Who have experienced fever (rectal temperature ≥ 38.5°C) within the past 3 days or are suffering from a present acute infectious disease;

    Who have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 10 days;

    Who have any present or suspected serious chronic disease such as cardiac or autoimmune disease or insulin dependent diabetes;

    Who have leukemia, lymphomas, neoplasm;

    With a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy, including use of corticosteroids known to be associated with suppression of hypothalamic-pituitary-adrenal (HPA) axis (i.e., systemic corticosteroids [eg 1 mg/kg/day of prednisone or its equivalent] or chronic use of inhaled high-potency corticosteroids [budesonide 800 µg per day or fluticasone 750 µg per day]). Those subjects who are known to have asthma and did conclude a systemic corticosteroid therapy above the mentioned limit at least 30 days previous to entering the study shall not be excluded.


    Who have received blood, blood products or a parenteral immunoglobulin preparation;
    With a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;

    Who have any other serious chronic disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease;

    Who have a history of seizure disorder;

    With an genetic anomaly (known cytogenic disorders) e.g., Down’s syndrome;

    Who with their parents/legal guardians are planning to leave the area of the study site before the end of the study period;

    With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

    Subjects that have a history of serologically or clinically confirmed HIV, Hepatitis B or Hepatitis C infection;
    E.5 End points
    E.5.1Primary end point(s)
    To demonstrate non-inferiority, 10 days after the booster vaccination, of the memory antibody response (in terms of percent responders) to Neisseria meningitidis serogroup C after 1 dose of Menjugate® at 2 months of age plus a booster in the second year of life (study group 2) in comparison with the memory antibody response after 2 doses of Menjugate at 2 and 4 months of age plus a booster in the second year of life (study group 1), as measured by bactericidal assay using rabbit complement (rBCA)
    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 Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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
    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 months28
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months28
    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) Yes
    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
    Infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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 Decision2005-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
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