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    Summary
    EudraCT Number:2007-004978-16
    Sponsor's Protocol Code Number:V59P5E1
    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:2007-11-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-004978-16
    A.3Full title of the trial
    A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
    A.4.1Sponsor's protocol code numberV59P5E1
    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 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 nameNovartis Meningococcal ACWY Conjugate Vaccine
    D.3.2Product code V59
    D.3.4Pharmaceutical form Powder and solvent for solution 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 nameMenA-CRM
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 mcg to dose (0.5 ml)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameMenC-CRM
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mcg to dose (0.5 ml)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameMenW-CRM
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mcg to dose (0.5 ml)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameMenY-CRM
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mcg to dose (0.5 ml)
    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 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
    Novartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitidis and septicemia caused by Neisseria meningitidis serogroups A, C, W-135 and Y.
    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 evaluate the immunity against meningococcal serogroups A, C, W-135 and Y at 40 and 60 months of age in children who were vaccinated with MenACWY- at 2, 4 and 12 months of age, in terms of percentage of participants with human SBA (hSBA) titers ≥ 1:8 for each of meningococcal serogroups A, C, W-135 and Y (Men A, C, W, Y).
    E.2.2Secondary objectives of the trial
    - To evaluate the persistence of immunity against meningococcal serogroups A, C, W-135 and Y at 40 and 60 months of age in children who were vaccinated with MenACWY- at 2, 4 and 12 months of age, in terms of percentage of participants with hSBA titers ≥ 1:4 and hSBA geometric mean titers (GMTs) for each of Men A, C, W, Y.
    - To evaluate the immunity against meningococcal serogroups A, C, W-135, Y at 60 months of age in age-matched children, who have received the site-specific primary immunization schedule in terms of percentage of participants with hSBA titers ≥ 1:4 and GMTs for each of Men A, C, W-135, and Y.
    - To evaluate the immunity against Men A, C, W-135, Y at 40 and 60 months of age in children who were vaccinated with MenACWY+ at age 2, 4 and 12 months, as measured by percentage of subjects with hSBA titer ≥ 1:4, percentage of subjects with hSBA titer ≥ 1:8 and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, and Y.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants eligible to be enrolled in the follow-on study are those who:
    1. have completed the V59P5 study;
    2. are healthy children age 40 months inclusive (+84 days) (Visit 7) or 60 months (+84 days) (Visit 8);
    3. are children in good health as determined by:
    - medical history;
    - physical assessment;
    - clinical judgment of the investigator;
    4. children whose parent(s) give written informed consent for their child to be enrolled in the study.
    E.4Principal exclusion criteria
    Participants who are not eligible for the follow up study are those:
    1. whose parents have not given or are unwilling or unable to give written informed consent for their child’s participation in the study;
    2. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
    a. receipt of immunosuppressive therapy within the past 30 days (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1mg/kg/day prednisone or equivalent during any of the previous 30 days, or cancer chemotherapy);
    b. receipt of immunostimulants;
    c. receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within the past 90 days and for the full length of the study;
    3. who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis serogroup A, C, W, or Y infection within 60 days prior to enrollment;
    4. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment;
    5. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome;
    6. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any study vaccine component (including latex allergy);
    7. who have any serious acute, chronic or progressive disease such as
    a. history of cancer (excluding minor non-melanoma skin cancer)
    b. diabetes mellitus
    c. arteriosclerotic disease
    d. autoimmune disease
    e. HIV infection or AIDS
    f. blood dyscrasias
    g. congestive heart failure
    h. renal failure
    i. severe malnutrition
    8. who have a condition that is a contraindication to vaccination;
    9. who are participating in any other clinical trial either currently or in the previous 90 days prior to enrolment;
    10. who are unable to adhere to the protocol;
    11. who have a 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)
    The anti-N. meningitidis serogroup A, C, W-135 and Y bactericidal activity titers will be measured by hSBA. These results will be expressed as GMT and percentage of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8.
    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 Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 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 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
    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 months37
    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.1.1.1In 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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    infants and toddlers
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state242
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 242
    F.4.2.2In the whole clinical trial 476
    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 Decision2007-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-09-20
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