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    Summary
    EudraCT Number:2014-005392-90
    Sponsor's Protocol Code Number:V59_75
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-31
    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 number2014-005392-90
    A.3Full title of the trial
    A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the Novartis MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations
    A.4.1Sponsor's protocol code numberV59_75
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02446691
    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 Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 Pharma Services AG
    B.4.2CountrySwitzerland
    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 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 Yes
    D.2.1.1.1Trade name Menveo
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics S.r.l
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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
    Prophylaxis against Neisseria Meningitidis serogroup A, C,W 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 against N meningitidis serogroups A, C, W and Y at approximately 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by hSBA titers ≥8.
    2. To evaluate the persistence of the antibody response against N. meningitidis serogroups A, C, W and Y at approximately 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by rSBA titers ≥8 and ≥128.
    3. To assess the safety and tolerability of MenACWY administered at 2-4-6 and12 months of age.
    E.2.2Secondary objectives of the trial
    1. To describe hSBA titers ≥8 and hSBA GMTs against N. meningitidis serogroups A, C, W and Y 1 month after a full vaccination series at 2,4,6 and 12 months of age
    2. To describe rSBA titers ≥8 and ≥128 rSBA and GMTs against N. meningitidis serogroups A, C, W and Y 1 month after a full vaccination series at 2,4,6 and 12 months of age
    3. To evaluate the persistence of the antibody response against N. meningitidis serogroups A, C, W and Y at approximately 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by hSBA GMTs and rSBA GMTs
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy male and female 2 month-old infants (55 – 89 days) on the day of consent.
    2. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
    3. Infants whose parents or legal guardians can comply with study procedures including follow-up
    Prior to receipt of study vaccination, subjects must be evaluated to confirm that they are
    eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.
    E.4Principal exclusion criteria
    Each subject must not have/have been:
    1. previously received any meningococcal A, C, W and Y vaccines;
    2. previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth;
    3. progressive, unstable or uncontrolled clinical conditions;
    4. a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy;
    5. experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
    6. any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
    7. received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth;
    8. ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study;
    9. any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw;
    10. any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study;
    11. received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study;
    12. received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops):
    13. relatives of site research staff working on this study.
    Prior to receipt of study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. At subsequent vaccinations, if subjects meet any of
    the original exclusion criteria listed above (with exception exclusion criteria 1, previous received the study vaccine), they should not receive additional vaccinations.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of subjects with hSBA ≥ 8 at Visit 6
    2. Percentage of subjects with rSBA ≥ 8 at Visit 6
    3. Percentage of subjects with rSBA ≥ 128 at Visit 6
    Percentage of subjects with:
    - Immediate reactions reported within 30 minutes after vaccination.
    - Solicited local and systemic adverse events from Day 1 to Day 7 following each vaccination
    - Medically-attended unsolicited AEs and AEs leading to premature withdraw from Day 1 to Visit 6 (at 24 months of age)
    - SAEs from Day 1 to Visit 6 (at 24 months of age)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Visit 6 (Month 24)
    2. Within 30 minutes after each vaccination
    3. Day 1 to Day 7 after each vaccination
    4. Day 1 to visit 6 (24 months of age) after each study vaccination.
    E.5.2Secondary end point(s)
    1. Percentage of subjects with hSBA ≥ 8 at Visit 5
    2. Percentage of subjects with rSBA ≥ 8 at Visit 5
    3. Percentage of subjects with rSBA ≥ 128 at Visit 5
    4. hSBA GMTs at Visits 5 and 6
    5. rSBA GMTs at Visits 5 and 6
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 13 (Visit 5)
    Month 24 (Visit 6)
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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 samples for the analysis of the primary and/or secondary objectives, to be achieved no later than 8 months after collection of the last biological sample visit 6.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months22
    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: 135
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 135
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 135
    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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