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    Summary
    EudraCT Number:2014-005083-15
    Sponsor's Protocol Code Number:V72_42
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-03
    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 number2014-005083-15
    A.3Full title of the trial
    A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Novartis rMenB+OMV NZ Vaccine in Healthy Subjects Aged 11 to 17 years in Korea.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of Meningococcal group B Vaccine in Healthy Subjects From 11 to 17 years in Korea.
    A.4.1Sponsor's protocol code numberV72_42
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01973218
    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 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 supportNovartis Vaccines and Diagnostics S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostics S.r.l.
    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 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 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.3.9.2Current sponsor codeV72
    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.3.9.2Current sponsor codeV72
    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 287-953 purified antigen
    D.3.9.2Current sponsor codeV72
    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.3.9.2Current sponsor codeV72
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prophylaxis Aganist Invasive Group B Meningococcal Disease
    E.1.1.1Medical condition in easily understood language
    Group B 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
    Immunogenicity:
    To assess the immunogenicity following two doses (Day 1 and Day 31) of Novartis rMenB+OMV NZ vaccine and control vaccines in healthy adolescents, as measured by the percentage of subjects with serum bactericidal activity (SBA) titer ≥ 1:4 against indicator strains H44/76, 5/99 and NZ98/254 one month after the second dose (Day 61).
    E.2.2Secondary objectives of the trial
    immunogenicity
    -Assess responses post two doses of rMenB+OMV NZ vaccine & control vaccines as measured by SBA geometric mean titers (GMTs) at baseline (Day 1, prior to vaccination) & one month after the second dose (Day 61);& the geometric mean ratio (GMR) of post-vaccination to pre-vaccination (baseline) GMTs
    -Assess response after two doses of rMenB+OMV NZ vaccine & control vaccines as measured by the percentage of subjects with a fourfold rise in SBA titers from baseline
    -Evaluate response after two doses of rMenB+OMV NZ vaccine and control vaccines as measured by Enzyme-linked Immunosorbent Assay (ELISA) geometric mean concentration (GMC); & the GMR of ELISA post-vaccination to pre-vaccination (baseline) GMCs

    Safety
    - Local & systemic reactions reported from Day 1 to Day 7 postvaccination
    - All other adverse events (AEs) reported from Day 1 to Day 7 postvaccination.
    - Serious AEs(SAEs), medically attended AEs & AEs leading to premature withdrawal throughout study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

    Individuals eligible to be enrolled into this study are male and female subjects:
    1. 11-17 years of age inclusive who have given their written assent and whose parent or legal guardian has 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;
    4. With a negative urine pregnancy test (for female subjects only).
    E.4Principal exclusion criteria
    In order to participate in this study, all subjects must meet NONE of the exclusion criteria described below:
    1. History of any 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. Pregnancy or nursing (breastfeeding) mothers;
    5. Any serious chronic or progressive disease.
    6. Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives;
    7. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of subjects with an SBA titer ≥1:4 at baseline (Day 1) and Day 61 for each of the three indicator strains (H44/76, 5/99, and NZ98/254) for both the rMenB+OMV NZ vaccine and control vaccine group.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day1 and Day61
    E.5.2Secondary end point(s)
    Immunogenicity Endpoints:
    ▫ SBA GMTs at each time point and GMRs of post-vaccination to pre-vaccination (baseline) GMTs for each of the three indicator strains (H44/76, 5/99, and NZ98/254) and for each vaccine group.
    ▫ The percentage of subjects with a fourfold rise in SBA titers from baseline (Day 1) to Day 61 for each of the three indicator strains (H44/76, 5/99, and NZ98/254) and for each vaccine group.
    ▫ ELISA GMCs at baseline and at Day 61 and GMRs for post-vaccination to prevaccination (baseline) GMCs for vaccine antigen 287-953 in each vaccine group.

    Safety Endpoints:
    Safety will be measured throughout the entire study period (from Day 1 to Day 61) for each group. Analysis of safety will be presented overall and by injection number.
    E.5.2.1Timepoint(s) of evaluation of this end point
    SBA GMTs and GMRs - Day 1 to Day 61
    Fourfold rise in SBA titers - Day 1 to Day 61
    ELISA GMCs - Day 61
    Safety - Day 1 to Day 61
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    MenACWY
    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
    Korea, Republic of
    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
    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 3.
    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 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: 264
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Subject and/or legal guardian and/or witness (if subject/legal guardian were unable to read and write) signed the consent form
    indicating their agreement to participate in the study before conducting study-related procedures.
    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 264
    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: Korea, Republic of
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