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    The EU Clinical Trials Register currently displays   39188   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2017-001993-40
    Sponsor's Protocol Code Number:MET62
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-10-18
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2017-001993-40
    A.3Full title of the trial
    Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered as a Booster Dose in Children Vaccinated 3 Years Earlier as Toddlers
    A.4.1Sponsor's protocol code numberMET62
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1183-5988
    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 SponsorSanofi Pasteur
    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 supportSanofi Pasteur
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur
    B.5.2Functional name of contact pointClinical Team Leader
    B.5.3 Address:
    B.5.3.1Street Address1541, avenue Marcel Merieux
    B.5.3.2Town/ cityMarcy l'Etoile
    B.5.3.3Post code69280
    B.5.3.4CountryFrance
    B.5.6E-maildiane.vandervliet@sanofipasteur.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 nameMenACYW Conjugate Vaccine
    D.3.2Product code 395
    D.3.4Pharmaceutical form 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 INNNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36479
    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 INNNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    D.3.9.4EV Substance CodeSUB31471
    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 INNNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36482
    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 INNNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) No
    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
    Healthy meningococcal vaccine primed male and female children aged 4-5 years who were previously vaccinated 3 years (± 45 days) earlier at 12 to 23 months of age in study MET54
    E.1.1.1Medical condition in easily understood language
    Healthy meningococcal vaccine primed male and female children aged 4-5 years who were previously vaccinated 3 years (± 45 days) earlier at 12 to 23 months of age in study MET54
    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
    Immunogenicity
    1) To describe the antibody persistence of meningococcal serogroups A,
    C, Y, and W before a booster dose in children who received either
    MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers

    2) To describe the antibody responses to meningococcal serogroups A, C,
    Y, and W 30 days after a booster dose of MenACYW conjugate
    vaccine in children who received either

    3) To describe the antibody responses against tetanus toxoid 30 days after
    a booster dose of MenACYW conjugate vaccine in children who
    received either MenACYW conjugate vaccine or Nimenrix® 3 years
    earlier as toddlers

    Safety
    To describe the safety profile of a booster dose of MenACYW conjugate
    vaccine in children who received either MenACYW conjugate vaccine or
    Nimenrix® 3 years earlier as toddlers
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    An individual must fulfill all of the following criteria in order to be eligible
    for trial enrollment:
    1) Participated in and completed (attended Visit 2) study MET54

    2) Informed consent form has been signed and dated by the parent(s) or
    another legally acceptable representative (and by an independent
    witness, if required by local regulations)

    3) Subject and parent/legally acceptable representative are able to attend
    all scheduled visits and to comply with all trial procedures
    E.4Principal exclusion criteria
    An individual fulfilling any of the following criteria is to be excluded from
    trial enrollment:
    1) Participation in the 4 weeks preceding the trial vaccination or planned
    participation during the present trial period in another clinical trial
    investigating a vaccine, drug, medical device, or medical procedure

    2) Receipt of any vaccine in the 4 weeks (28 days) preceding the trial
    vaccination or planned receipt of any vaccine prior to Visit 2 except for
    influenza vaccination, which may be received at a gap of at least
    2 weeks before or after the study vaccines. This exception includes
    monovalent pandemic influenza vaccines and multivalent influenza
    vaccines. If the subject is due to receive vaccination(s) recommended
    for his / her age by the national immunization schedule at the time of
    the study, the subject will be recommended to complete his/her
    immunization schedule after Visit 2.

    3) Previous vaccination against meningococcal disease with either the trial
    vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or
    conjugate meningococcal vaccine containing serogroups A, C, Y, or W;
    or meningococcal B vaccine) with the exception of the single dose of
    meningococcal vaccine administered as part of study MET54

    4) Receipt of immune globulins, blood or blood-derived products in the
    past 3 months

    5) Known or suspected congenital or acquired immunodeficiency; or
    receipt of immunosuppressive therapy, such as anti-cancer
    chemotherapy or radiation therapy, within the preceding 6 months; or
    long-term systemic corticosteroid therapy (prednisone or equivalent for
    more than 2 consecutive weeks within the past 3 months)

    6) History of meningococcal infection, confirmed either clinically,
    serologically, or microbiologically

    7) At high risk for meningococcal infection during the trial (specifically,
    but not limited to, subjects with persistent complement deficiency, with
    anatomic or functional asplenia, or subjects traveling to countries with
    high endemic or epidemic disease)

    8) Known systemic hypersensitivity to any of the vaccine components, or
    history of a life-threatening reaction to the vaccine used in the trial or to
    a vaccine containing any of the same substances

    9) Verbal report of thrombocytopenia, contraindicating intramuscular
    vaccination in the Investigator’s opinion

    10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding
    inclusion, contraindicating intramuscular vaccination

    11) Personal history of Guillain-Barré syndrome (GBS)

    12) Personal history of an Arthus-like reaction after vaccination with a
    tetanus toxoid-containing vaccine

    13) Chronic illness that, in the opinion of the Investigator, is at a stage
    where it might interfere with trial conduct or completion

    14) Moderate or severe acute illness/infection (according to Investigator
    judgment) on the day of vaccination or febrile illness (temperature
    ≥ 38.0°C). A prospective subject should not be included in the study
    until the condition has resolved or the febrile event has subsided

    15) Receipt of oral or injectable antibiotic therapy within 72 hours prior to
    the first blood draw.

    16) Identified as a natural or adopted child of the Investigator or employee
    with direct involvement in the proposed study
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity
    1) Antibody titers against meningococcal serogroups A, C, Y, and W
    measured by hSBA and rSBA :
    a) At D0 (baseline) and D30 in toddlers after having received a single
    dose of either MenACYW conjugate vaccine or Nimenrix®, as part
    of study MET54
    b) At D0 (baseline) in children before receiving a booster dose of
    MenACYW conjugate vaccine as part of study MET62 (3 years after
    having received a single dose of either MenACYW conjugate
    vaccine or Nimenrix®)

    2) Antibody titers against meningococcal serogroups A, C, Y, and W
    measured by rSBA and hSBA at D0 (baseline) and D30 after the
    administration of a booster dose of MenACYW conjugate vaccine in
    children who received either MenACYW conjugate vaccine or
    Nimenrix® 3 years earlier as toddlers

    Tetanus toxoid is contained as a carrier protein in both the investigational vaccine and the control vaccine that was used in study MET54. Therefore, blood samples will also be tested to assess:

    3) Antibody concentrations against tetanus toxoid at D0 (baseline) and
    D30 after the administration of a booster dose of MenACYW
    conjugate vaccine in children who received either MenACYW
    conjugate vaccine or Nimenrix® 3 years earlier as toddlers


    Safety
    • Occurrence, nature (Medical Dictionary for Regulatory Activities
    [MedDRA] preferred term [PT]), duration, intensity, and relationship to
    vaccination of any unsolicited systemic AEs reported in the 30 minutes
    after vaccination
    • Occurrence, time of onset, number of days of occurrence, intensity,
    action taken, and whether the reaction led to early termination from the
    study, of solicited (prelisted in the subject’s diary card and electronic
    case report form [CRF]) injection site reactions occurring up to 7 days
    after vaccination
    • Occurrence, time of onset, number of days of occurrence, intensity,
    action taken, and whether the reaction led to early termination from the
    study, of solicited (prelisted in the subject’s diary card and CRF)
    systemic reactions occurring up to 7 days after vaccination
    • Occurrence, nature (MedDRA PT), time of onset, duration, intensity,
    action taken, relationship to vaccination (for systemic AEs only), and
    whether the event led to early termination from the study, of unsolicited
    AEs up to Visit 2 after vaccination
    • Occurrence, nature (MedDRA PT), time of onset, duration, seriousness
    criteria, relationship to vaccination, outcome, and whether the SAE led
    to early termination from the study, of SAEs, including AESIs,
    throughout the trial
    E.5.1.1Timepoint(s) of evaluation of this end point
    The duration of each subject's participation in the study will be 30 to 44 days which includes one day for vaccination, 30 days of safety follow up, and a postvaccination
    sample at Visit 2 (30 to 44 days after the vaccination at Visit 1).
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 Yes
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 in October 2018
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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: 188
    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: 188
    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.4.1In the member state188
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-10
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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