Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China
연구 개요
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.
- 스폰서
- 리드: 사노피
- 적응증
- Meningococcal Infection, Healthy Volunteers
- 중재
- MenACYW conjugate vaccine, MenACYW135 polysaccharide vaccine, MenAC conjugate vaccine
- 목표 등록
- 1,602명
- 시작일
- 2025-09-26
- 완료(예정)
- 2026-09-23
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