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    Summary
    EudraCT Number:2014-004577-16
    Sponsor's Protocol Code Number:V59_36
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-07
    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 number2014-004577-16
    A.3Full title of the trial
    A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life
    A.4.1Sponsor's protocol code numberV59_36
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01214837
    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.1.3.4CountryUnited 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
    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
    B.5.2Functional name of contact pointPosting Director
    B.5.3 Address:
    B.5.3.1Street Address350 Massachusetts Avenue
    B.5.3.2Town/ cityMassachusetts
    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 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 Menveo
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics
    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 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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Prevnar 13
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 name13- valent Pneumocaoccal conjugate vaccine
    D.3.4Pharmaceutical form Suspension 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
    Prophylaxis against Neisseria meningitidis serogroup A, C, W and Y diseases.
    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
    1. To demonstrate a sufficient immune response 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.
    2. To demonstrate immunological non-inferiority of two MenACWY infant doses and a toddler dose (doses at 2, 4 and 12 months of age) to three infant doses and a toddler dose (doses at 2, 4, 6 and 12 months of age) as measured by percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups C, W and Y at 13 months of age.
    E.2.2Secondary objectives of the trial
    - Immune response against A,C,W and Y serogroup polysaccharides among subjects 2 (baseline), 3 (single dose at 2 months), 4 (single dose at 2 months), 5 (doses at 2, 4 months) and 7 (doses at 2, 4 and 6 months) months old.
    - Immune response at 7 months of age (2 doses at 2 and 4 months of age)
    - Persistence of the bactericidal activity of 2 MenACWY infant doses and 3 infant doses as measured by percentage of subjects with hSBA ≥ 1:8 at 12 months of age
    - Immune responses at 1 month after a toddler dose of MenACWY at 12 months of age following a 2 vs. a 3 infant dose schedule as measured by GMTs and 4-fold rise in hSBA.
    - Effect of concomitant administration of MenACWY on immune responses to PCV-13 antigens when measured at 7 months of age and 13 months of age.
    - Percentage of subjects with at least one severe systemic reaction during days 1-7 after any vaccination
    - Safety and tolerability of MenACWY when given concomitantly with
    routine infant vaccines.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Infants of both genders in good general health were eligible for this
    study. The parents/legal representatives had to provide written informed consent and be available for all study visits.
    E.4Principal exclusion criteria
    1. Any individual who previously received any meningococcal vaccine or any vaccine against D, T, P, inactivated poliovirus vaccine (IPV) or oral polio vaccine (OPV), Hinfluenzae type b (Hib) or pneumococcus. Prior doses of BCG vaccine (1 dose) and/or HBV (up to 2) were permitted.
    2. Any individual 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 of longer than or equal to 2 weeks associated with apnea or whooping).
    3. Any individual who had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W, or Y), B pertussis, Hib, C diphtheriae, polio, or pneumococcal infection at any time since birth.
    4. Any individual with a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
    5. Any individual who had any present or suspected serious acute (eg, leukemia, lymphomas), or chronic disease (eg, with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (eg, Down’s syndrome).
    6. Any individual 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 any immunostimulants at any time since birth,
    c. receipt of any systemic corticosteroids since birth.
    7. Any individual who had suspected or known HIV infection or HIV related disease.
    8. Any individual who had received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
    9. Any individual who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
    10. Any individual who had any history of seizure.
    11. Any individual who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
    12. Any individual who had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
    13. Any individual who had received any investigational agents since birth or who expected to receive an investigational agent prior to the completion of the study (this includes all experimental preparations, including, for example, experimental feeding formulas).
    14. Other vaccinations were not to be administered 28 days prior to visit 1 (age 2 months) through study termination except for vaccines that were specified in the study protocol. Influenza vaccines could be administered up to 15 days prior to study vaccines being administered and at least 15 days after study vaccinations had been administered.
    15. Any individuals who were relatives of the research staff.
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of subjects with hSBA ≥1:8 for meningococcal serogroups A, C, W and Y at one month after the 12-month MenACWY vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    13 months of age
    E.5.2Secondary end point(s)
    - Percentage of subjects with hSBA ≥1:8 for meningococcal serogroups A,C W and Y;
    - Four-fold rise in hSBA from pre- to post-toddler dose for each MenACWY
    serogroup;
    - Geometric mean titers (GMT) for each MenACWY serogroup;
    - Percentage of subjects with IgG antibody concentration ≥0.35 μg/mL and ≥1.0 μg/mL against pneumococcal capsular polysaccharides for each PCV-13 serotype;
    - Geometric mean concentrations (GMC) of antibodies against each PCV-13 serotype
    - Percentage of subjects with postvaccination reactions (including percentage of subjects reporting at least 1 severe solicited systemic AE after any study vaccination), reported SAEs and medically attended
    AEs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 13 months of age
    - Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age
    - 12 months of age
    - Day 1 to 7 for reactogenicity
    - Throughout the study for SAEs/medically attended AEs
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Routine vaccines; PCV-13
    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
    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 months7
    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: 750
    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: 750
    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
    Infants approximately 2 months of age were recruited for this study.
    If the infants were eligible, and if the parents/legal representatives were willing, signed informed consent was obtained.
    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 750
    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
    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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