Status:
RECRUITING
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
Lead Sponsor:
Sanofi
Conditions:
Meningococcal Infection
Healthy Volunteers
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
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 vacci...
Detailed Description
The duration of each participant's participation will be approximately 180 days.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 2 2026
Estimated Enrollment :
1602 Patients enrolled
Trial Details
Trial ID
NCT07135986
Start Date
September 26 2025
End Date
November 2 2026
Last Update
January 9 2026
Active Locations (1)
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1
Investigational Site Number : 1561000
Nanning, Guangxi, China, 530028