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    Summary
    EudraCT Number:2015-001030-16
    Sponsor's Protocol Code Number:V102_16E1
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-04-28
    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 number2015-001030-16
    A.3Full title of the trial
    A Phase 2b, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of the 3rd Dose 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
    Assessing the Effectiveness, Immunogenicity and Safety of Meningococcal ABCWY Vaccine Administered to Healthy Adolescents
    A.4.1Sponsor's protocol code numberV102_16E1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02285777
    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 Inc.
    B.1.3.4CountryUnited States
    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 Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostics Inc.
    B.5.2Functional name of contact pointPosting Director
    B.5.3 Address:
    B.5.3.1Street Address350 Massachusetts Avenue
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    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 nameMeningococcal (groups A, B, C, W, and Y) vaccine
    D.3.4Pharmaceutical form Powder and solvent 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 INNmeningococcal ACWY polysaccharide conjugate vaccine
    D.3.9.3Other descriptive nameMENINGOCOCCAL A/C/Y/W-135 POLYSACCHARIDE VACCINE
    D.3.9.4EV Substance CodeSUB76885
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number64
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrecombinant meningococcal B protein
    D.3.9.3Other descriptive nameMENINGOCOCCAL GROUP B VACCINE
    D.3.9.4EV Substance CodeSUB128786
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) No
    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
    Novartis Meningococcal ABCWY conjugate vaccine is intended for
    prevention of meningitis and septicemia caused by Neisseria
    meningitidis serogroups A, B, C, W and Y.
    E.1.1.1Medical condition in easily understood language
    Novartis Meningococcal ABCWY conjugate vaccine is intended for
    prevention of meningitis and septicemia caused by Neisseria
    meningitidis serogroups A, B, 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 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
    3-dose series, when compared to a single dose of MenACWY.
    E.2.2Secondary objectives of the trial
    1 Safety, reactogenicity 3rd dose MenABCWY.
    2 Effectiveness MenABCWY against MenB: bactericidal activity 1:4 dilution, enc-hSBA, 4 months, 3 doses.
    3 Effectiveness MenABCWY against MenB: bactericidal activity 1:8 dilution, enc-hSBA 1, 4 months, 3 doses.
    4 Effectiveness MenABCWY against MenB: bactericidal activity 1:4 and 1:8 dilution, enc-hSBA 1, 4 months, 3 doses.
    5 Distribution of subjects by % MenB strains killed at 1:4 and 1:8 dilutions, enc-hSBA 1, 4 months, 3 doses.
    6 Immunogenicity MenABCWY against MenB: % subjects with enc-hSBA titer ≥ 4 and ≥ 8 1, 4 months, 3 doses.
    7 Immunogenicity MenABCWY against MenB: hSBA GMTs, % subjects with hSBA titers ≥ LLQ, ≥5, ≥8, ≥16, ≥32, ≥64, ≥128 and % subjects with 2-, 3- and 4-fold rise in hSBA titer 1, 4 months, 3 doses.
    8 Immunogenicity MenABCWY against MenA, C, W, Y: hSBA GMTs, % subjects with hSBA titers ≥LLQ, ≥ 8, ≥ 16, ≥ 32, ≥ 64, ≥128 and % subjects with 2-, 3- and 4-fold rise in hSBA titer 1, 4 months, 3 doses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adolescents who completed V102_16 study and received the study vaccines as assigned in the protocol (either two doses of the MenABCWY or one dose each of MenACWY and Placebo).
    E.4Principal exclusion criteria
    1) Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis.
    2) History of any meningococcal vaccine administration other than vaccination given in the parent V102_16 protocol.
    E.5 End points
    E.5.1Primary end point(s)
    1) The 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
    Day 31, 1 month after the 3-dose vaccination series
    E.5.2Secondary end point(s)
    1) Percentages of subjects without bactericidal activity at 1:4 dilution against each US N. meningitidis serogroup B strain at 4 months after 3 doses.
    2) Percentages of subjects without bactericidal activity at 1:8 dilution against each US N. meningitidis serogroup B strain at 1 and 4
    months after 3 doses.
    3) Percentages of strains with VE values corresponding to predefined effectiveness ranges at 1:4 dilution at 1 month after 3 doses.
    4) Percentages of strains with VE values corresponding to predefined effectiveness ranges at 1:4 dilution at 4 months after 3 doses.
    5) Percentages of strains with VE values corresponding to predefined effectiveness ranges at 1:8 dilution at 1 month after 3 doses.
    6) Percentages of strains with VE values corresponding to predefined effectiveness ranges at 1:8 dilution at 4 months after 3 doses.
    7) Percentage of US N. meningitidis serogroup B strains killed at 1:4 and 1:8 dilutions at 1 and 4 months after 3 doses.
    8) Percentage of subjects with enc-hSBA ≥ 1:4 and enc-hSBA ≥ 1:8 1 and 4 months after 3 doses.
    9) hSBA Geometric Mean Titers (GMTs) against the N. meningitidis serogroup B test strains.
    10) Percentages of subjects with hSBA titers against N. meningitidis serogroup B test strains ≥ Lower Limit of Quantitation (LLQ) at 1
    and 4 months after 3 doses.
    11) Percentages of subjects with a four-fold rise in hSBA titer against the N. meningitidis serogroup B test strains at 1 and 4 months after
    3 doses.
    12) hSBA GMTs against N. meningitidis serogroups A, C, W and Y.
    13) Percentages of subjects with hSBA titers against the N. meningitidis serogroup A, C, W and Y ≥ LLQ at 1 and 4 months after 3 doses.
    14) Percentages of subjects with a four-fold rise in hSBA titer against the N. meningitidis serogroup B test strains at 1 and 4 months after
    3 doses.
    15) Number of subjects reporting any solicited local or systemic Adverse Events (AEs).
    16) Number of subjects reporting unsolicited AEs after any vaccination.
    17) Number of subjects reporting any serious AEs (SAEs), medically-attended AEs and AEs leading to premature withdrawal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) 4 months after 3 doses
    2) 1 and 4 months after 3 doses
    3) 1 month after 3 doses
    4) 4 months after 3 doses
    5) 1 month after 3 doses
    6) 4 months after 3 doses
    7) 1 and 4 months after 3 doses
    8) 1 and 4 months after 3 doses
    9) 1 and 4 months after 3 doses
    10) 1 and 4 months after 3 doses
    11) 1 and 4 months after 3 doses
    12) hSBA GMTs against N. meningitidis serogroups A, C, W and Y.
    13) 1 and 4 months after 3 doses
    14) 1 and 4 months after 3 doses
    15) Day 1 (6 hours) to Day 7 after vaccination
    16) Day 1 to Day 30 after any vaccination
    17) Entire study period
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 Yes
    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
    Evaluation of primary and secondary objectives requires the testing of biological samples from the study subjects, which can only be completed after all samples are collected. The last samples for the analysis of the secondary immunogenicity objectives will be taken at the last study visit. For the purpose of this study, end of trial 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.
    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 months6
    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: 291
    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: 182
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 109
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 14
    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 305
    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: United States
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