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    Summary
    EudraCT Number:2014-003514-91
    Sponsor's Protocol Code Number:V59P10
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-09-30
    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 number2014-003514-91
    A.3Full title of the trial
    A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with that of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age
    A.4.1Sponsor's protocol code numberV59P10
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/93/2011
    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 pointAnh Phung
    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-mailanh.phung@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 solvent 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
    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
    Menningococcal 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
    To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine with the immunogenicity of a single injection of PS vaccine (Menomune), defined as the percentage of subjects with seroresponse in human serum bactericidal assay against N meningitidis serogroups A, C, W135, and Y at 1 month after vaccination, when administered to healthy children 2 to 10 years of age.
    To compare the percentage of subjects presenting at least one severe (solicited) systemic reaction to the Novartis MenACWY conjugate vaccine with the percentage presenting at least one severe systemic reaction to the licensed meningococcal ACWY polysaccharide (PS) vaccine (Menomune) during the first 7 days (day 1 to 7) following a single injection administered to healthy children 2 to 10 years of age.
    E.2.2Secondary objectives of the trial
    To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine and the immunogenicity of a single injection of PS vaccine (Menomune), defined as: percentage of subjects with hSBA ≥ 1:4, percentage of subjects with hSBA ≥ 1:8, and hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W135, and Y at 1 month after vaccination, when administered to healthy children 2 to 10 years of age.
    To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine and the immunogenicity of a single injection of PS vaccine (Menomune), defined as: percentage of subjects with hSBA ≥ 1:8, percentage of subjects with hSBA ≥ 1:4, and hSBA GMTs against N meningitidis serogroups A, C, W135, and Y at day 181 after vaccination, when administered to healthy children 2 to 10 years of age.
    To describe and compare immediate hypersensitivity reactions; solicited adverse events (AEs), axillary temperature, AEs, and serious AEs.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 2-10 years of age inclusive whose parents or legal guardians have given written informed consent at the time of enrollment;
    2. available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
    3. in good health as determined by:
    • medical history,
    • physical assessment,
    • clinical judgment of the investigator;
    4. up to date with primary course and booster vaccines [BCG, and 4 doses of diphtheria-tetanus-pertussis vaccine (DTP), oral polio vaccine (OPV) or inactivated polio vaccine (IPV), H. influenzae type b vaccine (Hib), measles-mumps-rubella vaccine (MMR) and hepatitis A or B,
    according to the Argentinean vaccine calendar and subject age].
    E.4Principal exclusion criteria
    1. whose parent or legal guardian is unwilling or unable to give written informed consent to participate in the study;
    2. whose parent or legal guardian is perceived to be unreliable or unavailable for the duration of the study period;
    3. who had a previous or suspected disease caused by N. meningitidis;
    4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
    5. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
    6. who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
    7. who have received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine is anticipated within one month after vaccination (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and no less
    than 15 days after study vaccination);
    8. who have received a live viral vaccine within 60 days prior to enrollment;
    9. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to
    enrollment;
    10. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs
    of cardiac or renal failure or severe malnutrition). (Exception: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic
    corticosteroids are not eligible for enrollment);
    11. who have epilepsy or any progressive neurological disease;
    12. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
    13. who have a known or suspected impairment/alteration of immune
    function, either congenital or acquired or resulting from (for example):
    • receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy),
    • receipt of immunostimulants,
    • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study,
    • Common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
    14. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
    15. who have Down's syndrome or other known cytogenic disorders;
    16. whose families are planning to leave the area of the study site before the end of the study period;
    17. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
    2. Percentage of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 1 month after vaccination
    2) Day 1 to 7 post vaccination
    E.5.2Secondary end point(s)
    1) Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
    2) The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
    3) Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
    4) The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
    5) Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Day 1 and 29
    2) Day 1 and 29
    3) Day 181
    4) Day 181
    5) Day 1 to 7
    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 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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Meningococcal ACWY polysaccharide vaccine
    E.8.2.4Number of treatment arms in the trial2
    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
    Argentina
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days27
    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: 1500
    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: 1500
    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 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
    Infanta and Toddlers
    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 1500
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Novartis Vaccines and Diagnostics S.r.l.
    G.4.3.4Network Country Italy
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Argentina
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