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    Summary
    EudraCT Number:2025-000002-42
    Sponsor's Protocol Code Number:MEQ00086
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-04-10
    Trial 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 number2025-000002-42
    A.3Full title of the trial
    A descriptive, Phase IV, open-label, single-arm multi-center study to assess the immunogenicity and safety of MenQuadfi® as a booster vaccine in healthy toddlers 12 to 23 months of age who had been primed with at least 1 dose of another quadrivalent meningococcal conjugate vaccine, ie, Nimenrix® (MCV4-TT) or Menveo® (MCV4-CRM), in infancy.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of immunogenicity and safety of MenQuadfi® as a booster vaccine in toddlers 12 to 23 months, regardless of the quadrivalent meningococcal conjugate vaccine used for priming in infancy.
    A.4.1Sponsor's protocol code numberMEQ00086
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1277-6838
    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.1.3.4CountryFrance
    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.4.2CountryFrance
    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 pointGlobal Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address14 Espace Henry Vallée
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69007
    B.5.3.4CountryFrance
    B.5.4Telephone number+33169745769
    B.5.6E-mailsma-cta-coordination@sanofi.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 Yes
    D.2.1.1.1Trade name MenQuadfi®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form 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 Serogroup Y Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNeisseria meningitidis, serogroup C, polysaccharide, conjugated to tetanus toxoid
    D.3.9.4EV Substance CodeSUB316811
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup 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/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup W 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/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup 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/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 infection
    E.1.1.1Medical condition in easily understood language
    Meningococcal infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027274
    E.1.2Term Meningococcal infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To describe the immune response to a booster dose of MenQuadfi® as measured by the serum bactericidal assay using human complement (hSBA) in toddlers aged 12-23 months, who had
    been primed with at least 1 dose of another MCV4 vaccine during infancy
    • To describe the safety profile of a booster dose of MenQuadfi® administered to toddlers 12-23 months of age who had been primed with at least 1 dose of another MCV4 vaccine during
    infancy
    • To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 1 month after a booster dose of MenQuadfi® as measured by hSBA in toddlers 12-23 months of age who had been primed with at least 1 dose, 1 dose or 2 doses of another MCV4 vaccine during infancy
    • To describe the antibody responses to tetanus toxoid before and 1 month after a booster dose of MenQuadfi® in toddlers 12-23 months of age who had been primed with at least 1 dose of another MCV4 vaccine during infancy
    E.2.2Secondary objectives of the trial
    • To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 1 month after a booster dose of MenQuadfi® as measured by rSBA in toddlers 12-23 months of age who had been primed with at least 1 dose of another MCV4 vaccine during infancy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 12 to 23 months on the day of inclusion
    - Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator
    - Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose
    E.4Principal exclusion criteria
    - 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)
    - History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
    - At high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease)
    - Personal history of Guillain-Barré syndrome
    - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
    - Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances
    - Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. Prospective participant should not be included in the study until the
    condition has resolved or the febrile event has subsided
    - Receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID- 19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
    - Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine
    -Receipt of immunoglobulins, blood or blood-derived products in the past 3 months
    - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
    E.5 End points
    E.5.1Primary end point(s)
    1. hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W
    2. Number of participants with immediate adverse events (AEs)
    3. Number of participants with solicited injection site reactions or systemic reactions
    4. Number of participants with unsolicited AEs
    5. Number of participants with serious adverse events (SAEs)
    6. hSBA antibody titers against meningococcal serogroups A, C, Y, and W
    7. hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
    8. Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA
    9. hSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
    10. Anti-tetanus antibody concentrations
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. D31 (+14 days) after booster vaccination
    2. Within 30 minutes after vaccination
    3. Within 7 days after booster vaccination
    4. From D01 to D31 (+14 days) after booster vaccination
    5. From D01 to D31 (+14 days) after booster vaccination
    6. D01 and D31 (+14 days) after booster vaccination
    7. D01 and D31 (+14 days) after booster vaccination
    8. D01 and D31 (+14 days) after booster vaccination
    9. D01 and D31 (+14 days) after booster vaccination
    10. D01 and D31 (+14 days) after booster vaccination
    E.5.2Secondary end point(s)
    1. Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, Y, and W
    2. rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, Y, and W
    3. Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA
    4. rSBA meningococcal serogroups A, C, Y, and W vaccine seroresponse
    E.5.2.1Timepoint(s) of evaluation of this end point
    D01 and D31 (+14 days) after booster vaccination
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial1
    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
    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 months0
    E.8.9.2In all countries concerned by the trial days2
    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: 180
    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: 180
    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 and toddlers
    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 180
    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 Fundación Vacunar y Vacunar S.A.
    G.4.3.4Network Country Argentina
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Argentina
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