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

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

Timeline

Start

2019-04-09

Primary completion

2022-03-18

Completion

2022-03-18

Publications

• Dbaibo GS, Balik I, Akdemir I, Buzgan T, Guner R, Boutros CF, Damaj S, Zein ZE, Merhi S, Faour K, Tfaily N, Khafaja S, Dogu A, Ceyhan M. Immunogenicity and Safety of Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Potential Hajj/Umrah Pilgrims Aged >/= 56 Years: A Phase III, Open-Label Study. Infect Dis Ther. 2026 Mar;15(3):769-785. doi: 10.1007/s40121-025-01298-w. Epub 2026 Jan 28.

Drugs

Indications

No indication recorded.