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    Summary
    EudraCT Number:2014-004605-33
    Sponsor's Protocol Code Number:V59P14
    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 number2014-004605-33
    A.3Full title of the trial
    A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered with Routine Infant Vaccinations to Healthy
    Infants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
    A.4.1Sponsor's protocol code numberV59P14
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00474526
    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, 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 & 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 & Diagnostics
    B.5.2Functional name of contact pointPosting Director
    B.5.3 Address:
    B.5.3.1Street Address350 Massachusetts Avenue
    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.3.4Pharmaceutical 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
    Meningococcal disease causes high rates of morbidity and mortality even among patients who receive early antibiotic treatment.
    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 assess the immunogenicity of four doses of MenACWY given to infants at 2, 4, 6 and 12 months of age as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y (US subjects).
    To compare the immunogenicity of the fourth dose of MenACWY given at 12 months of age in subjects who previously received three doses of MenACWY given at 2, 4 and 6 months of age to the immunogenicity of a single dose of MenACWY given to naïve subjects at 12 months of age, as measured by the ratio of GMTs, directed against N. meningitidis serogroups A, C, W, and Y (USsubjects)
    E.2.2Secondary objectives of the trial
    To assess immunogenicity of 3 doses of MenACWY at 2, 4, 6 months of age
    To compare immunogenicity of MenACWY given at 2, 6 months of age to MenACWY given at 2, 4, 6 months of age
    To demonstrate that immunogenicity of routine vaccines, when given concomitantly with MenACWY at 2, 6 or 2, 4, 6 months of age, is noninferior to that of routine vaccines given alone
    To assess antibody persistence at 12 or 16 months of age in subjects who previously received 2 or 3 doses of MenACWY
    To assess immunogenicity of dose 3 or 4 of MenACWY given at 12 or 16 months of age in subjects who previously received 2 or 3 doses of MenACWY
    To demonstrate that immunogenicity of routine vaccines, when given concomitantly with MenACWY in the 2nd year of life to subjects who previously received 2 or 3 doses of MenACWY, is noninferior to that of routine vaccines given alone
    To assess immunogenicity of 1 or 2 doses of MenACWY given at 12 months or 12 and 15 months of age
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals eligible to be enrolled in the study were those:
    1. who were healthy 2-month-old male or female infants (55 – 89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
    2. for whom a parent/legal representative had given written informed consent after the nature of the study had been explained;
    3. who were available for all the visits scheduled in the study;
    4. who were in good health as determined by:
    a. medical history
    b. physical assessment
    c. clinical judgment of the investigator
    Informed consent was obtained for all the subjects before enrollment into the study.
    E.4Principal exclusion criteria
    Individuals not eligible to be enrolled were those:
    1. whose parent/legal representative was unwilling or unable to give written informed consent to participate in the study;
    2. who had previously received any meningococcal vaccine;
    3. who had received prior vaccination with D, T, P (acellular or whole cell), IPV or OPV, H. influenzae type b (Hib) or Pneumococcus (a single prior dose of BCG or HBV was not a reason for exclusion);
    4. who had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period longer than or equal to 2 weeks associated with apnea or whooping);
    5. who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
    6. who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
    7. who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (rectal temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
    8. who had any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenetic disorders (e.g., Down’s syndrome);
    9. who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
    a. receipt of any immunosuppressive therapy at any time since birth
    b. receipt of immunostimulants at any time since birth
    c. receipt of any systemic corticosteroid since birth;
    10. who had a suspected or known HIV infection or HIV related disease;
    11. who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
    12. who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
    13. who had any history of seizure (one febrile seizure is not a reason for exclusion);
    14. who had received oral or parenteral antibiotic treatment in the 7 days prior to the scheduled blood draw;
    15. who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period;
    16. with any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives;
    17. who had taken any antipyretic medication in the previous 6 hours.
    18. who had received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age

    To compare the immunogenicity of the fourth dose of MenACWY given at 12 months of age in subjects who previously received three doses of MenACWY given at 2, 4 and 6 months of age to the immunogenicity of a single dose of MenACWY given to naïve subjects at 12 months of age, as measured by the ratio of GMTs, directed against N. meningitidis serogroups A, C, W, and Y (US subjects).
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 months of age (one month post-toddler vaccination)
    E.5.2Secondary end point(s)
    1.Solicited local and systemic reactions were collected day 1 to day 7 after each vaccination
    2.Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y
    3.Immunogenicity as measured by percentage of subjects with hSBA titer >=1:16, hSBA titer >=1:8, hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y.
    4.Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens in US and LA subjects
    5.Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens and 4 fold increase in GMC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    safety endpoints: day 1 to day 7 after each vaccination

    hsba>= threshold, and GMTs: 7 months of age, 1 month before toddler dose (12 or 16 months of age), 1 month after toddler dose (13 or 17 months of age)

    routine vaccines: 7 months of age, 1 month after toddler dose (13 or 17 months of age)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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 Yes
    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
    Routine Vaccines
    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
    Argentina
    Colombia
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Corresponds to the 6-month follow-up phone call to take place 6 months after the subject’s last study vaccination.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days14
    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: 4545
    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: 4545
    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 No
    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
    As healthy Infants were included in the study the subject’s legally acceptable representative was informed about the trialaccording to his /her capacity of understanding. Oral and written information was provided..
    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 4500
    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 & Diagnostics, Inc.
    G.4.3.4Network Country United States
    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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