Meningococcal infection MedDRA version: 20.0 Level: PT Classification code 10027274 Term: Meningococcal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: MenQuadfi®
Product Name: MenACYW conjugate vaccine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Neisseria Meningitidis Serogroup C Polysaccharide Conjugated to Tetanus
Sponsors
Sanofi Pasteur Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? yes Number of subjects for this age range: 450 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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);Secondary Objective: •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];Primary 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;Timepoint(s) of evaluation of this end point: 1. D1 (all participants), D31 (participants of 3 through 11 months of a | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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 vaccin | — |
Countries
China
Contacts
Public ContactGlobal Regulatory Affairs
Sanofi Pasteur Inc.
Outcome results
None listed