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    Summary
    EudraCT Number:2014-004477-16
    Sponsor's Protocol Code Number:V59_43
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-17
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-004477-16
    A.3Full title of the trial
    A phase 3, multi-center, open-label study to evaluate immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 75 years of age in India.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy subjects from 2 to 75 years of age in India.
    A.4.1Sponsor's protocol code numberV59_43
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01547715
    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 SponsorNovartis Healthcare Pvt. Ltd., Vaccines Division
    B.1.3.4CountryIndia
    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 supportNovartis Healthcare Pvt. Ltd., Vaccines Division
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines
    B.5.2Functional name of contact pointPosting Director
    B.5.3 Address:
    B.5.3.1Street AddressVia Fiorentina 1
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.6E-mailRegistryContactVaccinesUS@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Menveo
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics SRL
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenA-CRM
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP A OLIGOSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB31082
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenC-CRM
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB26743
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenW - CRM
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB31083
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenY-CRM
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP Y POLYSACCHARIDE
    D.3.9.4EV Substance CodeSUB26072
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y
    E.1.1.1Medical condition in easily understood language
    Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 immunogenicity of a single injection of MenACWY-CRM vaccine as
    measured by the percentage of subjects with hSBA seroresponse, directed against N.
    meningitidis serogroups A, C, W and Y.
    E.2.2Secondary objectives of the trial
    To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as
    measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects
    with hSBA titer ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals eligible for enrolment in this study are those:
    who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to
    whom the nature of the study has been explained and:
    - the parent/legal representative has provided written informed consent (≥2 - <18
    years of age).
    - have provided written assent (≥7-<18 years)
    - have provided written informed consent (≥18 to 75 years of age).
    2. who the investigator believes that they or their parents/legal representatives can and
    will comply with the requirements of the protocol (e.g., completion of the Diary Card,
    return for follow-up visit).
    3. who are in good health as determined by
    - medical history
    - physical exam
    - clinical judgment of the investigator
    4. who have a negative urine pregnancy test for female subjects of childbearing potential
    E.4Principal exclusion criteria
    Individuals not eligible to be enrolled in the study are those:
    1. who are unwilling or unable to give written informed assent or consent to participate
    in the study.
    2. who are perceived to be unreliable or unavailable for the duration of the study period.
    3. who had a previous or suspected disease caused by N. meningitidis.
    4. who had household contact with and/or intimate exposure to an individual with
    culture-proven N. meningitidis infection within 60 days prior to enrolment.
    5. who have previously been immunized with a meningococcal vaccine.
    6. who have received any investigational or non-registered product (drug or vaccine)
    within 28 days prior to enrolment or who expect to receive an investigational drug or
    vaccine prior to the completion of the study.
    7. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days
    (for live vaccines) prior to enrolment in this study or who are planning to receive any
    vaccine within 30 days from the study vaccines.
    (Exception: Influenza vaccine may be administered up to 15 days prior to study
    vaccination and at least 15 days after study vaccination)
    8. who have experienced within the 7 days prior to enrolment significant acute 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
    enrolment.
    9. who have any serious acute, chronic or progressive disease (e.g., any history of
    neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or
    AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe
    malnutrition).
    10. who have epilepsy or any progressive neurological disease.
    11. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any
    vaccine components.
    12. who have a known or suspected impairment/alteration of immune function, either
    congenital or acquired or resulting from (for example):
    - receipt of immunosuppressive therapy within 28 days prior to enrolment (any
    systemic corticosteroid administered for more than 5 days, or in a daily dose > 1
    mg/kg/day prednisone or equivalent during any of 28 days prior to enrolment, or
    cancer chemotherapy)
    - receipt of immunostimulants
    - receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
    derivatives within 90 days prior to enrolment and for the full length of the study
    13. who are known to have a bleeding diathesis, or any condition that may be associated
    with a prolonged bleeding time.
    14. who have any condition that, 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)
    Primary:
    ▫ Percentage of subjects with hSBA seroresponse
    Seroresponse is defined as:
    ▫ for subjects with a pre-vaccination hSBA titer <1:4, a postvaccination hSBA titer
    ≥1:8
    ▫ for subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at
    least four times the pre-vaccination titer.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 29
    E.5.2Secondary end point(s)
    Secondary:
    ▫ hSBA GMTs.
    ▫ Percentage of subjects with hSBA ≥1:8.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 29
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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.8.2.4Number of treatment arms in the trial3
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    India
    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
    For the purpose of this protocol, end of study is defined as the completion of the testing of such biological samples, to be achieved no later than 8 months after collection of the last
    biological sample visit (visit 2 of the last enrolled subject).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 69
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 69
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 51
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 180
    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
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: India
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