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RECRUITING
NCT07135986
PHASE3

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

Sponsor: Sanofi

View on ClinicalTrials.gov

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

BIOLOGICAL

MenACYW conjugate vaccine

Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection

BIOLOGICAL

MenACYW135 polysaccharide vaccine

Pharmaceutical form: Lyophilized powder-Route of administration:IM injection

BIOLOGICAL

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