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    Summary
    EudraCT Number:2014-004694-16
    Sponsor's Protocol Code Number:V59P21
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-17
    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 number2014-004694-16
    A.3Full title of the trial
    A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of ProQuad™ Vaccine When Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of and immune response to Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers with and without ProQuad™ vaccine.
    A.4.1Sponsor's protocol code numberV59P21
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00626327
    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 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 MenACWY conjugate vaccine
    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 ProQuad™
    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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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-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
    To compare the immune responses of :
    - ProQuad™ vaccine when administered with MenACWY vaccine to that of ProQuad™ vaccine alone to children 12 months of age, as measured by seroconversion rates to measles, mumps, and rubella, and seroprotection rates for varicella.
    - two doses of MenACWY given to children at 7 to 9 and 12 months of age, when either administered with ProQuad™ or given alone, as measured by percentage of subjects with serum bactericidal activity (hSBA) ≥1:8 against N. men serogroups A, C, W-135, and Y.
    ▫ To assess immunogenicity of two doses of MenACWY given to children at 7 to 9 and 12 months of age as measured by the percentage of subjects with hSBA ≥1:8 against N. men serogroups A, C, W-135, and Y.
    E.2.2Secondary objectives of the trial
    ▫ To compare immune responses of 2 doses of MenACWY given to children at 7 to 9 and 12 months of age, when administered with ProQuad™ at 12 months of age or when given alone, as measured by percentage (%)of subjects with hSBA ≥1:4 and hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W-135, and Y.
    ▫ To assess immune responses of ProQuad™ when administered with MenACWY or when given alone to children aged 12 months, as measured by GMTs for measles, mumps, rubella and varicella (MMRV).
    ▫ To assess anti-varicella antibody response when ProQuad™ administered with MenACWY or when given alone to children aged 12 months, as measured by % of subjects who show seroconversion.
    ▫ To assess immunogenicity of MenACWY after a single dose given at 7 to 9 months of age, as measured by % of subjects with hSBA ≥1:8, hSBA ≥1:4, and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, and Y.
    ▫ To describe the safety profile of subjects in each vaccine group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals eligible for enrollment in this study were those:

    Group I and II only:
    ▫ who were 7 to 9 months old (inclusive) and for whom, after the nature of the study
    was explained, the parent or legal guardian provided written informed consent;

    Group III only:
    ▫ who were 12 months old (inclusive, plus 14 days) and for whom, after the nature of
    the study was explained, the parent or legal guardian provided written informed
    consent;

    All groups:
    ▫ who received complete primary vaccination with recommended licensed vaccines;
    vaccination with Rotateq™ was not required for study entry
    ▫ who were available for all visits and telephone calls scheduled for the study;
    ▫ who were in good health as determined by:
    - medical history
    - physical assessment
    - clinical judgment of the investigator
    E.4Principal exclusion criteria
    Individuals not eligible to be enrolled in the study were those:
    ▫ whose parent or legal guardian was unwilling or unable to give written informed
    consent to participate in the study or who was unwilling or unable to give written
    informed assent to participate in the study;
    ▫ whose parent or legal guardian was perceived to be unreliable or unavailable for the
    duration of the study period;
    ▫ who had a previous or suspected disease caused by N. meningitidis;
    ▫ who had previous or suspected infection with measles, mumps, rubella, varicella,
    and/or herpes zoster;
    ▫ who had household contact with and/or intimate exposure to an individual with
    culture-proven N. meningitidis infection within 60 days prior to enrollment;
    ▫ who had household contact with and/or intimate exposure to an individual with
    measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine.
    2. Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.
    3. Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. 6 weeks post vaccination.
    2 and 3. 6 weeks post second dose.
    E.5.2Secondary end point(s)
    1. Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine.
    2. Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine.
    3. Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.
    4. Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.
    5. Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine.
    6. Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine.
    7. Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination.
    8. Number of Subjects Reporting Unsolicited Adverse Events After Vaccination.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 2. 6 weeks post vaccine dose 2.
    3 and 4. 6 weeks post vaccination.
    5 and 6. 1 month post vaccine dose 1
    7. up to 7 days after any vaccination.
    8. Day 1- Day 180 (through out 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
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    MMRV (Measles, Mumps, Rubella and Varicella) vaccine
    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 26-OCT-2010
    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 months11
    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: 1830
    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: 1830
    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 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
    children 7 to 9 months old and 12 months old
    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 1830
    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)
    6 month safety follow up
    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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