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    Summary
    EudraCT Number:2014-005059-25
    Sponsor's Protocol Code Number:V59P6E1
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-25
    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 number2014-005059-25
    A.3Full title of the trial
    A Phase 2b, Open-Label, Multi-Center Study to Evaluate the Persistence of Antibody Response and to Assess the Immune Response to a Booster Dose of MenACWY Conjugate Vaccine in Subjects Previously Vaccinated as Adolescents with Either MenACWY Conjugate Vaccine or Menomune®
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Persistence of antibody response at 5 years after one dose of MenACWY or Menomune®
    A.4.1Sponsor's protocol code numberV59P6E1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01018732
    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 &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 Ave
    B.5.3.2Town/ cityCambridge
    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 nameNovartis Meningococcal ACWY Conjugate Vaccine
    D.3.2Product code V59
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Novartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis A, C, W-135 and Y.
    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
    1. To evaluate the persistence of the antibody response at 5 years after one dose of MenACWY or Menomune, as measured by the percentage of subjects with bactericidal activity using human complement (hSBA) ≥1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
    2. To evaluate the antibody response to one dose of MenACWY in subjects who had previously received one dose of MenACWY compared to the antibody response to one dose of MenACWY in meningococcal vaccine-naïve subjects, as measured by hSBA geometric mean titers (GMTs) directed against N. meningitidis serogroups A, C, W-135 and Y, at 28 days after vaccination.
    E.2.2Secondary objectives of the trial
    1. To evaluate the persistence of the antibody response at 5 years after one dose of MenACWY or Menomune, as measured by hSBA GMTs and percentage of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
    2. To evaluate the antibody response to one dose of MenACWY in subjects who had previously received one dose of MenACWY compared to the antibody response to one dose of MenACWY in meningococcal vaccine-naïve subjects, as measured by percentage of subjects with seroresponse and percentage of subjects with hSBA ≥1:8 and hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 28 days after vaccination.
    3. To evaluate all remaining pairwise immunogenicity comparisons (as expressed as hSBA ≥1:4 and ≥1:8 and GMTs) between each of the three study groups at days 1, 7, and 28 after vaccination.
    Safety Objectives
    To assess the safety and tolerability of one dose of MenACWY in all study subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent of the subject was obtained and documented or, in the case of unemancipated minors, written informed consent of the parent or guardian with written informed assent of the subject.
    2. Individuals in good health as determined by
    - medical history
    - physical assessment
    - clinical judgment of the investigator
    3. Subjects between the ages of 16 and 23 years inclusive
    4. For subjects in groups I and II only, receipt of either MenACWY or Menomune®.
    5. A negative urine pregnancy test was required for female subjects
    E.4Principal exclusion criteria
    1. Individuals' parents or legal guardians or individuals who were unable to comprehend or unwilling to follow all required study procedures for the whole period of the study.
    2. History of documented invasive meningococcal disease.
    3. Received any other meningococcal vaccine at any time outside of study V59P6.
    4. Receipt of any vaccines in the 14 days preceding Visit 4 (Day 1) or expected receipt through the final blood draw at Visit 6 (Day 29).
    5. Received antibiotic therapy within the 72 hours prior to collection of a blood sample.
    6. Actively enrolled or scheduled to be enrolled in another clinical study during the planned period of this trial.
    7. Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).
    8. Individuals with suspected HIV infection or HIV related disease, or history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or receipt of immunosuppressive therapy within 6 months.
    9. Use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days.
    10. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
    11. Individuals who had any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
    12. Acute medical illness with or without fever within 72 hours or an oral temperature≥100.4°F (≥38.0°C) at the time of inclusion.
    13. Allergy to latex or items containing latex.
    14. Administration of immune globulin or other blood products within the past 90 days.
    15. Personal or family history of Guillain-Barré Syndrome.
    16. Suspected or known hypersensitivity to any of the vaccine components.
    17. Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures.
    18. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
    19. Individuals who were part of study personnel or close family members conducting this study.
    20. Any condition which, in the opinion of the investigator, posed a health risk to the participant or rendered them inappropriate for a research study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of Participants With Serum Bactericidal Activity ≥8 at 5 Years After Primary Vaccination.
    2. Geometric Mean Titer After Booster Vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Day 1 (5 years after primary vaccination).
    2. Day 8, Day 29 (5 years after primary vaccination).
    E.5.2Secondary end point(s)
    1. Percentage of Participants With Serum Bactericidal Activity ≥4 at 5 Years After Primary Vaccination.
    2. Geometric Mean Titer at 5 Years After Primary Vaccination.
    3. Percentage of Participants With Serum Bactericidal Activity ≥4 After Booster Vaccination.
    4. Percentage of Participants With Serum Bactericidal Activity ≥8 After Booster Vaccination.
    5. Geometric Mean Ratio After Booster Vaccination.
    6. Percentage of Subjects With hSBA Seroresponse After Booster Vaccination.
    7. Number of Subjects With at Least One Reactogenicity Sign After Booster Vaccination.
    8. Number of Subjects With unsolicited Adverse Events After Booster Vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 1 (5 years after primary vaccination).
    2. Day 1 (5 years after primary vaccination).
    3. Day 7, Day 28 post booster (5 years after primary vaccination).
    4. Day 7, Day 28 post booster (5 years after primary vaccination).
    5. Day 8 and Day 29 (at 5 Years After Primary Vaccination).
    6. Day 8, Day 29 (5 years after primary vaccination).
    7 and 8. Up to Day 7 (safety endpoints).
    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) 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 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) Yes
    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
    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
    LVLS
    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 days6
    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: 40
    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: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 170
    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 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
    adolescents
    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 210
    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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