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    Summary
    EudraCT Number:2014-004476-30
    Sponsor's Protocol Code Number:V72_41
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-10-24
    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 number2014-004476-30
    A.3Full title of the trial
    A Phase 3, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of Novartis rMenB+OMV NZ Vaccine Formulated with Outer Membrane Vesicle (OMV) Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study Evaluating the Safety and Immunogenicity of Novartis rMenB+OMV NZ Vaccine Formulated with Outer Membrane Vesicle (OMV) Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
    A.4.1Sponsor's protocol code numberV72_41
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01423084
    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 Vaccines and Diagnostics SRL
    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 supportNovartis Vaccines and Diagnostics SRL
    B.4.2CountryItaly
    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 pointNovartis Vaccines
    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 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.2.1.1.1Trade name Bexsero
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics S.r.l. , Italy
    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 namerMenB+OMV NZ
    D.3.4Pharmaceutical form Suspension 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 INNN meningitidis 961c purified antigen
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIS GROUP B PROTEIN 961C
    D.3.9.4EV Substance CodeSUB126665
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN meningitidis 936-741 purified antigen
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIS GROUP B PROTEIN 936-741
    D.3.9.4EV Substance CodeSUB126666
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN meningitidis ΔG287-953 purified antigen
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B PROTEIN 287-953
    D.3.9.4EV Substance CodeSUB126662
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOMV from N meningitidis Strain NZ 98/254
    D.3.9.3Other descriptive nameOUTER MEMBRANE VESICLES FROM NEISSERIA MENINGITIDIS GROUP B (STRAIN NZ 98/254)
    D.3.9.4EV Substance CodeSUB77057
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    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 invasive meningococcal disease
    E.1.1.1Medical condition in easily understood language
    Meningococcal Disease
    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 demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.
    E.2.2Secondary objectives of the trial
    Immune response at one month after a primary vaccination course of two rMenB + OMV doses administered one month apart as measured by the percentage of subjects with hSBA ≥1:5 and as measured by the ratio of hSBA post-vaccination to pre-vaccination GMTs [GMR] against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by the ratio of ELISA post-vaccination to pre-vaccination GMCs [GMR] against vaccine antigen 287-953.
    Immune response at two weeks after a primary vaccination course of two rMenB+OMV NZ doses administered one month apart as measured by hSBA GMT, the ratio of hSBA post-vaccination to pre-vaccination GMTs [GMR], and the percentage of subjects with hSBA ≥1:5 against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and
    as measured by ELISA GMC and the ratio of ELISA post-vaccination to pre-vaccination GMCs [GMR] against vaccine antigen 287-953.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 11-17 years of age inclusive who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment;
    2. who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period);
    3. in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
    E.4Principal exclusion criteria
    1. History of any serogroup B meningococcal vaccine administration;
    2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
    3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
    4. Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day;
    5. Antibiotics within 3 days (72 hours) prior to enrollment;
    6. Pregnancy or nursing (breastfeeding) mothers;
    7. Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry;
    8. Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
    9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants;
    10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
    11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
    12. Receipt of or intent to immunize with any other vaccine(s) within 30 days prior (60 days for live viral vaccines) and throughout the study period (exception: licensed flu-vaccine should not be administered within 14 days prior to enrollment; routine vaccine may be administered after the blood draw at the last study visit);
    13. Participation in another clinical trial within the last 90 days or planned for during study;
    14. Family members and household members of research staff;
    15. Any condition which in the opinion of the investigator and/or the Regional MD may interfere with the evaluation of the study objectives
    E.5 End points
    E.5.1Primary end point(s)
    • hSBA GMT at one month after the second vaccination for each of the three reference strains. Consistency of the immune response of the 2 lots of rMenB+OMV NZ will be assessed based on the ratio of the hSBA GMTs for each of the three reference strains at one month after the second vaccination. The equivalence interval will be (0.5, 2.0).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 61, ie, one month after the second vaccination
    E.5.2Secondary end point(s)
    • The percentage of subjects in each lot with hSBA ≥1:5 at one month after the second vaccination for each of the three reference strains (H44/76, 5/99, and NZ98/254) for each vaccine group.
    • The hSBA GMT increase (post-vaccination to pre-vaccination geometric mean ratio [GMR]) and associated two-sided 95% CI at each time point for each of the three N. meningitidis serogroup B reference strains and for each vaccine group.
    • The ELISA GMC increase (post-vaccination to pre-vaccination GMR) and associated two-sided 95% CI at each time point for vaccine antigen 287-953 and for each vaccine group.
    • The hSBA GMT and associated two-sided 95% CI at two weeks after the second vaccination in a subset of approximately 160 subjects (approximately 80 per lot) for each of three N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and for each vaccine group.
    • The ELISA GMC and associated two-sided 95% CI at two weeks after the second vaccination in a subset of approximately 160 subjects (approximately 80 per lot) for vaccine antigen 287-953 for each vaccine group.
    • The percentage of subjects with hSBA ≥1:5 at 2 weeks after the second vaccination in a subset of approximately 160 subjects (approximately 80 per lot) for each N. meningitidis serogroup B reference strain and vaccine group.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 45 and day 61, ie, two weeks and one month after the second vaccination
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    Australia
    Canada
    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
    LSLV
    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 months2
    E.8.9.2In all countries concerned by the trial days1
    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: 344
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 344
    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 No
    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 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 320
    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: Canada
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