drugset / Trial / NCT05093829
Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine
Phase 3
Completed
1325 enrolled
Emory University
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT.
Timeline
- Start
- 2022-03-24
- Primary completion
- 2023-03-10
- Completion
- 2025-02-20
Publications
- Diallo F, Haidara FC, Tapia MD, Dominguez Islas CP, Alderson MR, Hausdorff WP, Martellet L, Hosken N, Kapse D, Kulkarni PS, Townsend-Payne K, Vanni F, Posavad CM, Sow SO, Kotloff KL, Chen WH; NmCV-5 EPI study team. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, W, Y, and X when co-administered with routine childhood vaccines at ages 9 months and 15 months in Mali: a single-centre, double-blind, randomised, controlled, phase 3, non-inferiority trial. Lancet. 2025 Mar 29;405(10484):1069-1080. doi: 10.1016/S0140-6736(25)00046-7. Epub 2025 Mar 11.
- Stephens DS. Global Control of Meningococcal Disease. N Engl J Med. 2023 May 25;388(21):2003-2005. doi: 10.1056/NEJMe2301698. No abstract available.