Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
- Conditions
- Meningococcal InfectionHealthy Volunteers
- Interventions
- Biological: MenAC conjugate vaccine
- Registration Number
- NCT07135986
- Lead Sponsor
- Sanofi
- Brief Summary
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China.
Study details include:
* The study duration will be approximately 180 days.
* The vaccination visit will be Visit 1.
* The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.
- Detailed Description
The duration of each participant's participation will be approximately 180 days.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1504
- For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.)
- Participants who are healthy as determined by medical evaluation including medical history and physical examination.
- A female participant is eligible to participate if she is not pregnant or breastfeeding
Participants are excluded from the study if any of the following criteria apply:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy; or long-term systemic corticosteroid therapy
- History of meningococcal infection
- History of any neurologic disorders
- History of Guillain-Barré syndrome
- History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
- At high risk for meningococcal infection during the trial
- Known systemic hypersensitivity to any of the vaccine components
- Self-reported thrombocytopenia, contraindicating intramuscular vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
- 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
- Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- 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.
- The time since last vaccination of meningococcal vaccine was 2 years or less.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Green Bamboo (Lv Zhu) MenAC1-dose schedule MenAC conjugate vaccine 1 dose of Green Bamboo (Lv Zhu)'s MenAC conjugate vaccine to participants aged 7 through 17 years of age Group 3 MenACYW1-dose schedule MenACYW conjugate vaccine 1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age Group 1 MenACYW1-dose schedule MenACYW conjugate vaccine 1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age Group 4 Royal MenAC1-dose schedule MenAC conjugate vaccine 1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age
- Primary Outcome Measures
Name Time Method Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A and C Day 01 (pre-vaccination) and Day 31 (post- vaccination) 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C Day 01 (pre-vaccination) and Day 31 (post- vaccination) 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C Day 31 (post- vaccination) Antibodies titers are expressed as geometric mean titers
Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine Day 01 (pre-vaccination) and Day 31 (post- vaccination) 30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine Day 01 (pre-vaccination) and Day 31 (post- vaccination) 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C Day 01 (pre-vaccination) and Day 31 (post- vaccination) Antibody titers are expressed as geometric mean titers
- Secondary Outcome Measures
Name Time Method Presence of solicited systemic reactions Within 7 days post-vaccination Solicited systemic reactions include fever, headache, malaise and myalgia
Presence of SAEs Up to Day 181 post-vaccination SAEs, including adverse events of special interest (AESIs), reported throughout the study
Number of participants with immediate adverse events (AEs) Within 30 minutes post-vaccination Unsolicited systemic AEs that occur within 30 minutes after vaccination
Presence of solicited injection site reactions Within 7 days post-vaccination Solicited injection site reactions include injection site pain, erythema and swelling
Presence of unsolicited AEs Within 30 days post-vaccination