NCT06228586

Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam

A Phase III, Open-label, Single-center Study to Describe the Immunogenicity and Safety of a Single Dose of MenACYW Conjugate Vaccine in Participants Aged 12 Months and Older in Vietnam

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

Summary

The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam. The primary objectives of the study were: * To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 30 days after the administration of a single dose of MenACYW conjugate vaccine * To describe the safety profile of a single dose of MenACYW conjugate vaccine The duration of each participant's participation will be approximately 30 to 44 days.

Detailed description

The duration of each participant's participation was approximately 30 to 44 days.

Conditions

• Meningococcal Infection
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine	Pharmaceutical form:Liquid solution-Route of administration:Intramuscular injection

Timeline

• Start date: 2024-01-18
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2024-01-29
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

4 sites across 1 country: Vietnam

Regulatory

• FDA-regulated drug study