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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
Sponsor: Sanofi
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.
Official title: A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
1602
Start Date
2025-09-26
Completion Date
2026-11-02
Last Updated
2026-03-02
Healthy Volunteers
Yes
Interventions
MenACYW conjugate vaccine
Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
MenACYW135 polysaccharide vaccine
Pharmaceutical form: Lyophilized powder-Route of administration:IM injection
MenAC conjugate vaccine
Pharmaceutical form:Lyophilized powder-Route of administration:IM injection
Locations (2)
Investigational Site Number : 1561000
Nanning, Guangxi, China
Investigational Site Number : 1561003
Liuchow, China