NCT03869866

Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 56 Years
• Healthy volunteers: Accepted

Summary

The primary objectives of this study are: * To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine * To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine * To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine * To describe the safety profile of a single dose of MenACYW conjugate vaccine

Detailed description

Study duration per participant is approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.

Conditions

• Healthy Volunteers (Meningococcal Infection)

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine	Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Timeline

• Start date: 2019-04-09
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2019-03-11
• Last updated: 2025-03-17
• Results posted: 2025-03-17

Locations

3 sites across 2 countries: Lebanon, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study