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    Summary
    EudraCT Number:2014-005161-72
    Sponsor's Protocol Code Number:V59P20
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-12-05
    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 number2014-005161-72
    A.3Full title of the trial
    A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine with One Dose of Licensed Meningococcal ACWY Conjugate administered to Healthy Children 2-10 Years of Age.
    A.4.1Sponsor's protocol code numberV59P20
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00616421
    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 & Diagnostics
    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 & Diagnostics
    B.4.2CountryUnited States
    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-mailregistrycontactus@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
    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.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 Menactra
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pasteur Inc
    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 nameMenactra
    D.3.4Pharmaceutical form 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
    Prophylaxis for 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
    To compare the immunogenicity of a single dose of MenACWY with the immunogenicity of a single dose of Menactra, defined as percentage of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month after vaccination, when administered to healthy children 2 to 10 years of age.




    *Below mentioned is the secondary objective, due to space constraints/limitation in secondary objective field it is mentioned in the primary objective.

    To describe safety profile of MenACWY and to compare the percentages of subjects in the MenACWY and Menactra vaccine groups when administered to healthy children 2 to 10 years of age
    E.2.2Secondary objectives of the trial
    To assess and the immunogenicity of two doses of MenACWY , administered 2 months apart, and compare it to the immunogenicity of a single dose of MenACWY directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month after vaccination, when administered to healthy children 2 to 5 years of age;

    To compare the immunogenicity of a single dose of MenACWY with the immunogenicity of a single dose of Menactra, directed against N.meningitidis serogroups A, C, W-135, and Y, at 1 month after vaccination, when administered to healthy subjects 2 to 10 years of age;

    To compare the immunogenicity of a single dose of MenACWY with the immunogenicity of a single dose of Menactra, defined as percentage of subjects with seroresponse, hSBA 1:4, hSBA 1:8, and hSBA GMT response directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month after vaccination, when administered to healthy subjects 2 to 5 years of age or 6 to 10 years of age.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. who are 2-10 years of age inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent and who have given written assent, if applicable;
    2. who are available for all visits and telephone calls scheduled for the study;
    3. who are in good health as determined by:
    medical history
    physical assessment
    clinical judgment of the investigator
    4. who are up-to-date with age-appropriate routine childhood vaccinations
    E.4Principal exclusion criteria
    1. whose parent or legal guardian is unwilling or unable to give written informed consent to participate in the study or who are unwilling or unable to give written informed assent 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) (Exception: Receipt of OMP-containing Hib vaccines is permitted);
    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 30 days after vaccination (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
    8. who have received a live viral vaccine within 30 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 body temperature 38°C) within 3 days prior to enrollment;
    Reason for delaying blood draw:
    Antibiotics in the blood may interfere with the evaluation of antibodies (i.e., by Serum Bactericidal Activity), therefore a blood draw should be postponed if the subject has received oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw.
    10. who have any serious acute, chronic or progressive disease such as
    history of cancer (excluding minor non-melanoma skin cancer)
    diabetes mellitus
    arteriosclerotic disease
    autoimmune disease
    HIV infection or AIDS
    blood dyscrasias
    congestive heart failure
    renal failure
    severe malnutrition
    11. who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome; Note: one febrile seizure is not a reason for exclusion
    12. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component including latex;
    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
    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 seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 1 month after vaccination.
    E.5.2Secondary end point(s)
    1. Percentage of subjects with seroresponse, hSBA 1:4, hSBA 1:8 and hSBA GMTs directed against N.meningitidis serogroups A, C, W-135, and Y after administration of two doses of MenACWY administered 2 months apart in children aged 2 to 5 years of age.

    2. Percentage of subjects with hSBA 1:4, hSBA 1:8 and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, and Y after administration of single daose of MenACWYafter administration of single dose of MenACWY administered in children aged 2 to 10 years of age.

    3. Percentage of subjects with hSBA 1:4, hSBA 1:8 and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, and Y after administration of single daose of MenACWYafter administration of single dose of MenACWY administered in children aged 2 to 5 or 6 to 10 years of age.

    4. Immediate hypersensitivity reactions (within 30 minutes) following vaccination

    4. Percentages of subjects reporting with local and systemic reactions.

    5. Adverse events, SAEs, Medically Significatnt AEs occuring throughout the study at all timepoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 1 month after vaccination.

    2. 1 month after vaccination.

    3. 1 month after vaccination.

    4. 30 minuted following vaccination.

    5. Days 1 - 7

    6. Throughout the study
    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
    Immunogenecity
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    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 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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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
    Canada
    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
    A phone call at 6 months after the last vaccination is the last scheduled contact for follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days1
    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: 2820
    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: 2820
    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 2820
    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)
    NA
    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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