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    Summary
    EudraCT Number:2025-000103-23
    Sponsor's Protocol Code Number:MEQ00075
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-04-09
    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 number2025-000103-23
    A.3Full title of the trial
    Phase I Open-Label, Age De-escalation Safety and Immunogenicity Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents, Children, Toddlers, and Infants in China
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of a Novel Vaccine against Meningococcal Meningitis Compared with Locally Licensed Meningococcal Vaccines
    A.4.1Sponsor's protocol code numberMEQ00075
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1256-9026
    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 Inc.
    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 Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur Inc.
    B.5.2Functional name of contact pointGlobal Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressDiscovery Drive
    B.5.3.2Town/ citySwiftwater
    B.5.3.3Post codePA 18370-0187
    B.5.3.4CountryUnited States
    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 C 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.IMP: 2
    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 Group A and Group C Meningococcal Conjugate Vaccine
    D.2.1.1.2Name of the Marketing Authorisation holderRoyal (Wuxi) Bio-pharmaceutical Co., Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationChina
    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 nameNot applicable
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Lyophilisate 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
    D.3.9.3Other descriptive nameNeisseria meningitidis group A polysaccharide
    D.3.9.4EV Substance CodeSUB39522
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN. meningitidis group C polysaccharide
    D.3.9.3Other descriptive nameN. meningitidis group C polysaccharide
    D.3.9.4EV Substance CodeSUB26071
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    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) 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: 3
    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 Mening A Con®
    D.2.1.1.2Name of the Marketing Authorisation holderBeijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationChina
    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 nameMeningococcal Group A and C Conjugate Vaccine
    D.3.4Pharmaceutical form Suspension 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, conjugated to tetanus toxoid
    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 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) 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 safety profile of MenACYW conjugate vaccine and the safety profiles of the control vaccines (ie, locally-licensed MenAC conjugate vaccines: Royal or Green Bamboo)
    E.2.2Secondary objectives of the trial
    •To describe the antibody (AB) responses against meningococcal serogroups A,C,Y and W for MenACYW conjugate vaccine and against serogroups A and C for Green Bamboo's MenAC conjugate vaccine following the administration of a single dose of the corresponding vaccine in children and adolescents 7-17 years of age (Cohort I [Groups 1 and 2])
    •To describe the AB responses against meningococcal serogroups A,C,Y and W for MenACYW conjugate vaccine and against serogroups A and C for Royal’s MenAC conjugate vaccine following the administration of a single dose of the corresponding vaccine in children 2-6 years of age (Cohort II [Groups 3 and 4])
    •To describe the AB responses against meningococcal serogroups A,C,Y, and W for MenACYW conjugate vaccine and against serogroups A and C for Royal’s MenAC conjugate vaccine following the administration of a single dose of the corresponding vaccine in toddlers 12-23 months of age (Cohort III [Groups 5 and 6])
    [See translation section for continuation]
    •To describe the AB responses against meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine and against serogroups A and C for Royal’s MenAC conjugate vaccine following the administration of two doses of the corresponding vaccine in infants 6-11 months of age (1 month interval between doses) (Cohort IV [Groups 7 and 8])
    •To describe the AB responses against meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine and against serogroups A and C for Green Bamboo’s MenAC conjugate vaccine following the administration of three doses of the corresponding vaccine in infants 3-5 months of age (1 month interval between doses) (Cohort V [Groups 9 and 10])
    •To describe the immunogenicity of MenACYW conjugate vaccine and the immunogenicity of the control vaccines (ie, locally-licensed MenAC conjugate vaccines: Royal or Green Bamboo) to meningococcal serogroups A, C, Y, and W before and 30 days after the administration of 1, 2, or 3 doses of the corresponding vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For participants 3 through 23 months of age: Born at full term of pregnancy (≥37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the Investigator

    For participants 12 through 17 years of age: A female participant is eligible to participate if she is not pregnant or breastfeeding
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    - History of meningococcal infection
    - History of Guillain-Barré syndrome
    - At high risk for meningococcal infection during the trial
    E.5 End points
    E.5.1Primary end point(s)
    1. Presence of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any study vaccination
    2. Presence of solicited injection site reactions (pre listed in the participant’s diary card [DC] and case report form [CRF]) up to 7 days after each and any study vaccination
    3. Presence of solicited systemic reactions (pre-listed in the participant’s DC and CRF) up to 7 days after each and any study vaccination
    4. Presence of unsolicited AEs up to 30 days after each and any study vaccination
    5. Presence of SAEs, throughout the trial, ie, from Visit 1 (first vaccination) to 6 months after the last study vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. D1 (all participants), D31 (participants of 3 through 11 months of age), and D61 (participants of 3 through 5 months of age)
    2. D1 to D8 (all participants), D31 to D38 (participants of 3 through 11 months of age), D61 to D68 (participants of 3 through 5 months of age)
    3. D1 to D8 (all participants), D31 to D38 (participants of 3 through 11 months of age), D61 to D68 (participants of 3 through 5 months of age)
    4. D1 to D31 (all participants), D31 to D61 (participants of 3 through 11 months of age), D61 to D91 (participants of 3 through 5 months of age)
    5. D1 to D181 (participants from 12 months through 17 years of age), D1 to D211 (participants of 6 through 11 months of age), D1 to D241 (participants of 3 through 5 months of age)
    E.5.2Secondary end point(s)
    1. Cohort I [Groups 1 and 2]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Green Bamboo’s MenAC conjugate vaccine measured using serum bactericidal assay using rabbit complement (rSBA) in serum specimens collected on D01 (pre-vaccination) and D31 (30 days [+7 days] after vaccination with the corresponding study vaccine)
    2. Cohort II [Groups 3 and 4]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Royal’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D31 (30 days [+7 days] after vaccination with the corresponding study vaccine)
    3. Cohort III [Groups 5 and 6]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Royal’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D31 (30 days [+7 days] after vaccination with the corresponding study vaccine)
    4. Cohort IV [Groups 7 and 8]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Royal’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D61 (30 days [+7 days]) after the second vaccination with the corresponding study vaccine)
    5. Cohort V [Groups 9 and 10]: Vaccine seroresponse of meningococcal serogroups A, C, Y, and W for MenACYW conjugate vaccine or of serogroups A and C for Green Bamboo’s MenAC conjugate vaccine measured using rSBA in serum specimens collected on D01 (pre-vaccination) and D91 (30 days [+7 days] after the third vaccination with the corresponding study vaccine)
    6. Antibody titers in terms of Geometric mean titers (GMT) against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after one dose of MenACYW conjugate vaccine in Group 1 and antibody titers in terms of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after one dose of Green Bamboo’s vaccine in Group 2 (participants 2 through 17 years of age; 1 dose of vaccine)
    7. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after one dose of MenACYW conjugate vaccine in Group 3 and against meningococcal serogroups A and C measured by rSBA 30 days after one dose of Royal’s vaccine in Group 4 (participants 2 through 6 years of age, 1 dose of vaccine)
    8. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after one dose of MenACYW conjugate vaccine in Group 5 and antibody titers in terms of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after one dose of Royal’s vaccine in Group 6 (participants 12 through 23 months of age, 1 dose of vaccine)
    9. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after the last dose of MenACYW conjugate vaccine in Group 7 and antibody titers in terms of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after the last dose of Royal’s vaccine in Group 8 (participants 6 through 11 months of age, 2 doses of vaccine 30 days apart)
    10. Antibody titers in terms of GMTs against meningococcal serogroups A, C, Y, and W measured by rSBA 30 days after the last dose of MenACYW conjugate vaccine in Group 9 and antibody titers in terms of GMTs against meningococcal serogroups A and C measured by rSBA 30 days after the last dose of Green Bamboo’s vaccine in Group 10 (participants 3 through 5 months of age, 3 doses of vaccine, 30 days apart)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. D1 and D31
    2. D1 and D31
    3. D1 and D31
    4. D1 and D61
    5. D1 and D91
    6. D1 and D31
    7. D1 and D31
    8. D1 and D31
    9. D1 and D61
    10. D1 and D91
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Randomized, open-label, parallel design
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial10
    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
    China
    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
    Last contact of the last participant
    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 months2
    E.8.9.2In all countries concerned by the trial days11
    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: 450
    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: 270
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 90
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 90
    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
    Participants aged under 18 population
    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 450
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: China
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