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    Summary
    EudraCT Number:2015-000979-27
    Sponsor's Protocol Code Number:V102_16
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-05-07
    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 number2015-000979-27
    A.3Full title of the trial
    A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents.
    A.4.1Sponsor's protocol code numberV102_16
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02140762
    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
    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
    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
    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 nameMenACWY conjugate combined with rMenB + OMV
    D.3.2Product code MenABCWY
    D.3.4Pharmaceutical form Powder and solution for 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 INNRecombinant Neisseria meningitidis group B fHbp fusion protein
    D.3.9.2Current sponsor codeRecombinant Neisseria meningitis Protein 936-741
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96090
    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 INNRecombinant Neisseria meningitidis group B NHBA fusion protein
    D.3.9.2Current sponsor codeRecombinant Neisseria meningitis Protein 287-953
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96088
    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 INNRecombinant Neisseria meningitidis group B NadA protein
    D.3.9.2Current sponsor codeRecombinant Neisseria meningitis Protein 961c
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96089
    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 INNOuter membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4
    D.3.9.2Current sponsor codeOMV from N meningitidis Strain NZ 98/254
    D.3.9.3Other descriptive nameOUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 MEASURED AS AMOUNT OF TOTAL PROTEIN CONTAINING THE PORA P1.4 ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96091
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMeningococcal group A oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
    D.3.9.2Current sponsor codeMenA-CRM197 conjugate
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP A OLIGOSACCHARIDE CONJUGATED TO CRM197 PROTEIN
    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 INNMeningococcal group C oligosaccharide conjugated to Corynebacterium diphtheriae CRM197 protein
    D.3.9.2Current sponsor codeMenC-CRM197 conjugate
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C OLIGOSACCHARIDE CONJUGATED TO CRM197 PROTEIN
    D.3.9.4EV Substance CodeSUB31081
    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 INNMeningococcal group W-135 oligosaccharide Conjugate to Corynebacterium diphtheriae CRM197 protein
    D.3.9.2Current sponsor codeMenW-CRM197 conjugate
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197 PROTEIN
    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 INNMeningococcal group Y oligosaccharide Conjugate to Corynebacterium diphtheriae CRM197 protein
    D.3.9.2Current sponsor codeMenY-CRM197 conjugate
    D.3.9.3Other descriptive nameMENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CRM197 PROTEIN
    D.3.9.4EV Substance CodeSUB126362
    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 Yes
    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.IMP: 2
    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® Meningococcal group ACWY conjugate vaccine
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameMeningococcal Group A, C, W135 and Y conjugate vaccine
    D.3.2Product code MenACWY
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 placeboSolution 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 against invasive disease strains of N. meningitidis serogroup B.
    E.1.1.1Medical condition in easily understood language
    Prophylaxis against invasive disease strains of N. meningitidis serogroup B.
    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 effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity at 1:4 dilution using enc-hSBA at one month after the 2-doses vaccine series, when compared to a single dose of MenACWY.
    E.2.2Secondary objectives of the trial
    To assess effectiveness of MenABCWY vaccine against N. meningitidis B strains, as measured by enc-hSBA:
    - at 1:4 and 1:8 dilution at 1 and 4 months after 2 vaccine doses
    •To describe distribution of subjects by percentage of serogroup B strains killed at 1:4 and 1:8 dilution by enc-hSBA.
    •To assess immunogenicity of MenABCWY vaccine against the N. meningitidis serogroup B test strains:
    -as percentage of subjects with enc-hSBA ≥4 and ≥8
    •To assess immunogenicity of MenABCWY vaccine against the N. meningitidis serogroups A, C,W,Y and serogroup B test strains:
    -as hSBA GMTs, percentage of subjects with hSBA titers ≥Lower Limit of Quantitation (LLQ), ≥5,8,16,32,64,128 and percentage of subjects with 2-, 3-,4-fold rise in hSBA titer
    All compared to a single dose of MenACWY.
    •To evaluate safety of MenABCWY vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose
    legally acceptable representative has given written informed consent at the time of enrollment.
    • Female subjects of childbearing potential must have a negative urine pregnancy test.
    E.4Principal exclusion criteria
    • Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous
    immunization with any meningococcal vaccine.
    • Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without
    further microbiologic characterization.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects without bactericidal serum activity at 1:4 dilution using enc-hSBA against each of the endemic US N. meningitidis serogroup B strains.
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after the 2-dose vaccination series.
    E.5.2Secondary end point(s)
    1. Percentage of subjects without bactericidal serum activity at 1:4 and 1:8 dilution using enc-hSBA against each of the endemic US N. meningitidis serogroup B strains. The percentages of subjects will be averaged across all strains.
    2. Percentage of serogroup B invasive disease strains killed, in each subjects, at 1:4 and 1:8 dilutions using enc-hSBA.
    3. Percentage of subjects with enc-hSBA ≥ 4 and enc-hSBA ≥ 8 against the N.meningitidis serogroup B test strains.
    4. hSBA GMTs against the N. meningitidis serogroup B test strains.
    5. Percentages of subjects with hSBA titers ≥ LLQ, ≥ 5, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against the N. meningitidis serogroup B test strains.
    6. Percentages of subjects with 2-, 3-, and 4-fold rise in hSBA titer against the N. meningitidis serogroup B test strains.
    7. hSBA GMTs against N. meningitidis serogroups A, C, W and Y.
    8. Percentages of subjects with hSBA titers ≥ LLQ, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥ 128 against N. meningitidis serogroups A, C, W and Y.
    9. Percentages of subjects with 2-, 3-, and 4-fold rise in hSBA titer against N.meningitidis serogroups A, C, W and Y.

    Safety of the study vaccines will be assessed in all subjects in terms of the frequency and percentage of reported adverse events (AEs) including:
    1. Solicited local (i.e., pain, erythema and induration) and systemic (i.e. loss of appetite, headache, fatigue, myalgia, arthralgia, nausea, fever (body temperature ≥38°C (100.4°F));
    2. All unsolicited AEs;
    3. Medically-attended AEs;
    4. AEs leading to premature withdrawal;
    5. SAEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For Secondary End points:
    1. to 5.; 7.; 8. baseline, one and four months after the 2-dose vaccination series
    6.; 9. one and four months after the 2-dose vaccination series
    For Safety analysis:
    1. from Day 1 (6 hours) to Day 7 after each vaccination
    2. from Day 1 to Day 30 after each vaccination
    3. to 5. during the entire study period
    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 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) 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 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
    United States
    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 biological samples, to be achieved no later than 8 months after collection of the last biological sample at Visit Month 6.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months9
    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: 300
    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: 300
    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 300
    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)
    Any suspected Serious Adverse Events that occurs outside of the protocol-specified follow-up period but considered to be caused by the study vaccine must be reported to Novartis or its designee.
    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: United States
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