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    Summary
    EudraCT Number:2021-000104-38
    Sponsor's Protocol Code Number:MEQ00073
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-28
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-000104-38
    A.3Full title of the trial
    A Phase IIIb, Open-label, Multi-center Study to Evaluate the Immunogenicity and Safety of a Booster Dose and Describe the Immune Persistence of MenACYW Conjugate Vaccine with 5- and/or 10-year Booster Doses in Children and Adolescents who had been Primed with MenACYW Conjugate Vaccine as Toddlers.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year
    Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers
    A.4.1Sponsor's protocol code numberMEQ00073
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1255-4941
    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 SA
    B.5.2Functional name of contact pointMedical Affairs Europe
    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+33437 37 7525
    B.5.6E-mailisabelle.bertrand-gerentes@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.3.4Pharmaceutical 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 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 C Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    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/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.3.8 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.3.11 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
    - The purpose of the MEQ00073 study is to evaluate the immunogenicity and safety of a booster dose and describe the immune persistence of a
    priming dose of MenACYW conjugate vaccine in children and adolescents in Finland, Germany, Spain, and Hungary, who had been vaccinated with
    MenACYW conjugate vaccine approximately 5 or 10 years earlier as toddlers as part of the MET51 study, and to describe the immunogenicity
    and safety of a second booster dose and the persistence of a first booster dose of MenACYW conjugate vaccine in adolescents who had
    been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as children.
    - To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, W, and Y after the administration of a booster dose of
    MenACYW conjugate vaccine in children who received 1 dose of MenACYW conjugate vaccine approximately 5 years earlier as toddlers
    (Group 1)
    E.2.2Secondary objectives of the trial
    - To describe antibody persistence and antibody responses of meningococcal serogroups A,C,W,Y in children and adolescents who received MenACYW conjugate vaccine 5 or 10 years earlier as toddlers and in children who received booster dose 5 years after primary dose of MenACYW conjugate vaccine as toddlers
    - To describe antibody responses to tetanus toxoid before and 30 days after administration of each booster dose of MenACYW vaccine in
    children and adolescents who received MenACYW vaccine 5 or 10 years earlier as toddlers and in children who received a booster dose 5 years
    after primary dose as toddlers
    - To describe antibody responses to meningococcal serogroup C before and 30 days after administration of a booster dose of MenACYW in
    children and adolescents who received MenACYW vaccine 5 or 10 years earlier as meningococcal vaccine naïve toddlers or MenC-primed toddlers
    and in adolescents who received booster dose as children 5 years after receiving the primary dose (MET51 study)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Received MenACYW vaccine in MET51 study (Groups 1 and 3) and completed the study (attended Visit 2)
    - Participant and parent/ legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures
    - Covered by health insurance, if required by local regulations
    - Assent form (AF) has been signed and dated by the participant (if applicable) and informed consent form (ICF) has been signed and dated by the parent(s) or another LAR and by an independent witness, if required by local regulations
    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 trial (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 (GBS)
    - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid containing vaccine
    - Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
    - Verbal report by parent or LAR of thrombocytopenia or suspected thrombocytopenia, contraindicating intramuscular (IM) vaccination
    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
    - Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y) with the exception of licensed MenC vaccination received during infancy (MET51 Group 3), of the single dose of meningococcal vaccine administered as part of study MET51 (Group 1 and 3) and of Meningococcal B vaccine
    - Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination except for influenza vaccination, which may be received at least 2 weeks before or after study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
    - Receipt of immune globulins, 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
    - 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 trial investigating a vaccine, drug, medical device, or medical procedure
    - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
    - Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
    - Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
    - 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)
    Vaccine seroresponse against meningococcal serogroups A, C, W, and Y; Antibody titers measured by serum bactericidal assay using human complement (hSBA),
    Seroresponse defined as the proportions of participants with an hSBA pre-vaccination titer < 1:8 who achieved a post-vaccination titer ≥ 1:16 or participants with a pre-vaccination titer ≥ 1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 01 (baseline) and Visit 2 (30 days after the administration of a 5-
    year booster dose (Group 1)
    E.5.2Secondary end point(s)
    1. Antibody titers against meningococcal serogroups A, C, W, and Y before the administration of a booster dose of MenACYW conjugate vaccine (Group 1 and 2); Antibody titers measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA)
    2. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 (Group 2); Antibody titers measured by hSBA and rSBA
    3. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 (Group 1); Antibody titers measured by hSBA and rSBA
    4. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 1 and Visit 2 (Group 2); Antibody titers measured by hSBA and rSBA
    5. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 2 and Visit 3 (Group 2); Antibody titers measured by hSBA and rSBA
    6. Antibody titers against meningococcal serogroups A, C, W, and Y at Visit 3 and Visit 4 (Group 1); Antibody titers measured by hSBA and rSBA
    7. Antibody concentrations against tetanus toxoid at Visit 1 and Visit 2 (Group 1); Antibody concentration measured by immunoglobulin (Ig)G
    enzyme-linked immunosorbent assay (ELISA)
    8. Antibody concentrations against tetanus toxoid at Visit 3 and Visit 4 (Group 1); Antibody concentration measured by immunoglobulin (Ig)G
    enzyme-linked immunosorbent assay (ELISA)
    9. Antibody concentrations against tetanus toxoid at Visit 2 and Visit 3 (Group 2); Antibody concentration measured by immunoglobulin (Ig)G
    enzyme-linked immunosorbent assay (ELISA)
    10. Antibody titers against meningococcal serogroup C Visit 3 and Visit 4 (Group 1); Antibody titers measured by hSBA and rSBA
    11. Antibody titers against meningococcal serogroup C Visit 2 and Visit 3 (Group 2); Antibody titers measured by hSBA and rSBA
    12. Number of participants with immediate adverse events (AEs); Unsolicited systemic AEs reported within 30 minutes after vaccination
    13. Number of participants with solicited injection site reactions or systemic reactions; Pre-defined adverse reactions Injection site reactions: pain, redness and swelling Systemic reactions: fever, headache, malaise, myalgia
    14. Number of participants with unsolicited AEs; AEs other than solicited reactions
    15. Number of participants with serious adverse events (SAEs); SAEs (including adverse events of special interest [AESIs]) reported
    throughout the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Visit 1 (V1) (baseline) for Group 1 and Group 2
    2. V2 (60 months after baseline) for Group 2
    3. V3 (60 months after the administration of a 5-year booster dose) for Group 1
    4. V1 and V2 (30 days (30d) after the administration of 5-year booster dose of MenACYW conjugate vaccine) (Group 1)
    5/9/11. V2 and V3 (30d after the administration of a 10-year booster dose of MenACYW conjugate vaccine) (Group 2)
    6/8/10. V3 and V4 (30d after the administration of 10-year booster dose of MenACYW conjugate vaccine) (Group 1)
    7. V1 and V2 (Group 1)
    12. Within 30 minutes after vaccination
    13. Within 7d after vaccination
    14. Within 30d after vaccination
    15. From baseline until the End of Study (up to 5.5 years)
    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 Information not present in EudraCT
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 500
    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: 500
    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 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
    Children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 500
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-08
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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