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    Summary
    EudraCT Number:2021-001699-41
    Sponsor's Protocol Code Number:MEQ00074
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-08-14
    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 number2021-001699-41
    A.3Full title of the trial
    A Phase III, open-label, single-center study to describe the immunogenicity and safety of a single dose of MenACYW Conjugate Vaccine in participants aged 12 months and older in Vietnam
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on a MenACYW Conjugate Vaccine administered as a single dose in
    participants aged 12 months and older in Vietnam
    A.4.1Sponsor's protocol code numberMEQ00074
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1256-9172
    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 antibody responses to meningococcal serogroups A, C, W, and Y
    before and 30 days after the administration of a single dose of MenACYW conjugate vaccine
    • To describe the safety profile of a single dose of MenACYW conjugate vaccine
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged 12 months and above on the day of inclusion

    Adults:
    - Aged 18 and above on the day of inclusion
    - A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
    -- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
    OR
    -- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
    A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine ) within 1 week before the dose of study intervention.
    - Informed consent form has been signed and dated
    - Able to attend all scheduled visits and to comply with all study procedures

    Adolescents:
    - Aged 10 to 17 years on the day of inclusion
    - A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
    -- Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche.
    OR
    -- Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
    A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine ) within 1 week before the dose of study intervention.
    - Informed consent form has been signed and dated by both the participant and the parent (s ) or another legally acceptable representative and by an independent witness, if required by local regulations
    Assent form has been signed and dated by the participant (assent form required for participants aged 12 to 15 years ) or verbal consent has been obtained (for participants aged 10 to 11 years ), and 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
    - Participant and parent /legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures

    Children:
    - Aged 2 to 9 years on the day of inclusion
    - Verbal consent has been obtained (for participants aged 7 to 9 years ), and 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
    - Participant and parent /legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures

    Toddlers:
    - Aged 12 to 23 months on the day of inclusion
    - Informed consent form has been signed and dated by the parent (s ) or other legally acceptable representative and by an independent witness if required by local regulations
    - Participant and parent /legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
    E.4Principal exclusion criteria
    All:
    - Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination ) or planned participation during the present trial period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
    - Receipt of any vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
    - Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine)
    - Receipt of immune globulins, blood or blood-derived products in the past 3 months
    - History of any N. meningitidis infection, confirmed either clinically, serologically, or microbiologically
    - At high risk for meningococcal disease 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 )
    - 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
    - Personal history of Guillain-Barré syndrome (GBS)
    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection
    - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
    - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion
    - Moderate or severe acute illness /infection (according to Investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 37 .5 C) or hypothermia (axillary
    temperature ≤ 35 .5 C) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
    - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw

    Adults (>= 18 years) and Adolescents (10 to 17 years):
    - 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)
    - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination
    - Self-reported thrombocytopenia, contraindicating intramuscular injection
    - Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
    - Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

    Children (2 to 9 years)
    - 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)
    - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
    - Thrombocytopenia as reported by the parent /legally acceptable representative, or suspected thrombocytopenia contraindicating intramuscular injection
    - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

    Toddlers (12 to 23 months)
    - 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 since birth)
    - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
    - Thrombocytopenia as reported by the parent /legally acceptable representative, or suspected thrombocytopenia contraindicating intramuscular injection
    - 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)
    1- Geometric mean titers (GMTs ) of antibodies (Ab ) against meningococcal serogroups A, C, W, and Y
    2- Percentage of participants with Ab against meningococcal serogroups A, C, W, and Y above predefined thresholds
    3- Percentage of participants with Ab against meningococcal serogroups A, C, W, and Y above predefined thresholds
    4- Vaccine seroresponse against meningococcal serogroups A, C, W, and Y
    5- Number of participants with immediate adverse events (AEs)
    6- Number of participants with solicited injection site reactions
    7- Number of participants with solicited systemic reactions
    8- Number of participants with unsolicited AEs
    9- Number of participants with serious adverse events (SAEs )
    E.5.1.1Timepoint(s) of evaluation of this end point
    1- Day 01 (pre-vaccination ) and Day 31 (post- vaccination )
    2- Day 01 (pre-vaccination ) and Day 31 (post- vaccination )
    3- Day 01 (pre-vaccination ) and Day 31 (post- vaccination )
    4- Day 01 (pre-vaccination ) and Day 31 (post- vaccination )
    5- Within 30 minutes of vaccination
    6- Within 7 days of vaccination
    7- Within 7 days of vaccination
    8- Within 30 days of vaccination
    9- Within 30 days of vaccination
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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 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 Yes
    E.8.1.7.1Other trial design description
    Single group
    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
    Viet Nam
    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 years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days74
    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: 446
    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: 223
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 57
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 54
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    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
    Pediatric population
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Elderly
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 446
    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)
    Not applicable
    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: Viet Nam
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