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    Summary
    EudraCT Number:2014-005061-72
    Sponsor's Protocol Code Number:V59_33
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-27
    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 number2014-005061-72
    A.3Full title of the trial
    Phase 3, randomized, open label, controlled multi center study to evaluate the safety and immunogenicity of 4 doses of MenACWY conjugate vaccine, administered concomitantly with routine vaccines, among infants aged 2 months
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    safety and immunogenicity of 4 doses of MenACWY conjugate vaccine, administered concomitantly with routine vaccines, among infants aged 2 months
    A.4.1Sponsor's protocol code numberV59_33
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01000311
    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 Vaccines and Diagnostics
    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
    B.4.2CountryItaly
    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 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 nameMeningococcal Group A, C, W135 and Y conjugate vaccine
    D.3.2Product code MenACWY
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenA
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP A OLIGOSACCHARIDE
    D.3.9.4EV Substance CodeSUB31082
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenC
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C OLIGOSACCHARIDE
    D.3.9.4EV Substance CodeSUB26743
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenW
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE
    D.3.9.4EV Substance CodeSUB31083
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMenY
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP Y OLIGOSACCHARIDE
    D.3.9.4EV Substance CodeSUB126362
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 serogroups A, C, W, and Y
    E.1.1.1Medical condition in easily understood language
    Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y
    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 sufficiency of the immune response following 4 doses of MenACWY vaccine given at 2, 4, 6 and 12 months in healthy infants in terms of the proportion of subjects with an hSBA titer ≥ 1:8 at 1 month post vaccination, for each of the four meningococcal vaccine serogroups
    E.2.2Secondary objectives of the trial
    -To evaluate the proportion of subjects with post vaccination hSBA GMTs after 4 doses of MenACWY at 2, 4, 6 and 12 months against each of the four MenACWY serogroups
    -To evaluate the proportion of subjects with post vaccination hSBA titers ≥1:8, and hSBA GMTs after 3 doses of MenACWY at 2, 4, and 6 months against each of the four MenACWY serogroups
    -To demonstrate that the immune responses to routine concomitant vaccinations (pneumococcal, IPV, HBV, Hib, DTaP) are non-inferior when given with MenACWY compared with when given without MenACWY.
    -To assess the persistence of MenACWY immune responses at 12 months of age prior to the fourth dose.
    -To evaluate the proportion of subjects with four-fold rise in hSBA at 1 month post 4th dose as compared to the pre-4th dose titer against each of the four MenACWY serogroups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Two month-old infants (aged 55 – 89 days). Babies must have been born after a full-term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg.
    2) Documented written informed consent has been provided by the parent/legal representative after the nature of the study has been explained.
    3) Parent/legal representative are available for all visits scheduled in the study.
    4) Subjects are in good health as determined by :
    a) medical history
    b) physical assessment
    c) clinical judgment of the investigator
    E.4Principal exclusion criteria
    1) Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted.
    2) Subjects who have 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 of longer than or equal to 2 weeks associated with apnea or whooping).
    3) Subjects who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth.
    4) Subjects who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
    5) Subjects who have any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
    6) Subjects who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
    7) Subjects who have a suspected or known HIV infection or were born to a mother known to be HIV positive.
    8) Subjects who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
    9) Subjects who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
    10) Subjects who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period.
    11) Subjects who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
    12) Subjects who have 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.
    13) Subjects who are relatives of site research staff working on this study.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects with an (human serum bactericidal assay) hSBA ≥1:8 against each of the four meningococcal vaccine serogroups.
    Success criteria:
    The lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 1 month after the fourth dose, to be greater than 85% for serogroups C, W, or Y and greater than 80% for serogroup A.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after fourth dose, 13 months of age.
    E.5.2Secondary end point(s)
    MenACWY
    hSBA GMT,
    Percentage of subjects with at least four-fold rise in hSBA.

    Routine vaccines
    Pentacel (Post 6 month dose)
    -ELISA, Diphtheria antigen, % Subjects ≥0.1 IU/mL, GMC
    -ELISA, Tetanus antigen, % Subjects ≥0.1 IU/mL, GMC
    -ELISA, PT, FHA, Pertactin and FIM antigens, GMC, Seroresponse: In initially seronegative infants, ≥4 times LLQ; in initially
    seropositive infants, at least 4 times prevaccination concentration
    -ELISA, PRP-T Hib antigen, % Subjects ≥0.15 μg/mL, GMC, % Subjects ≥1.0 μg/mL

    Prevnar® (Post 6 and 12 month dose)
    ELISA, PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F antigens, GMC and % Subjects ≥0.35 g /mL.

    HBV (post 6 month dose)
    -ELISA, HBsAg antigen, % Subjects ≥10 mIU/mL, GMC
    E.5.2.1Timepoint(s) of evaluation of this end point
    MenACWY, 1 month after 3rd and 4th dose (4fold rise); 1 month after each dose (hSBA GMT),
    Pentacel, 1 month after 3rd dose, ie, at 7 months of age,
    Prevnar®, 1 months after 3rd and 4th doses, ie, 7 and 13 months of age,
    HBV, 1 month after 3rd dose, ie, at 7 months of age.
    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 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 Yes
    E.8.2.3.1Comparator description
    Routine vaccines only
    E.8.2.4Number of treatment arms in the trial2
    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
    Australia
    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
    LVLS
    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 months5
    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: 520
    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: 520
    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 520
    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)
    Any AE occurring at any time outside the observation period or after the end of the study and considered to be caused by the study vaccine, and therefore a possible adverse reaction, must be reported.
    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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