Study to Assess Immunegnicity & Safety of Pentavalent Meningococcal Vaccine (NmCV-5)

Summary

This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years \& 2-10 years (400 NmCV-5 recipients \& 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).

Timeline

Start

2019-08-20

Primary completion

2020-02-23

Completion

2021-03-04

Publications

• Background Chen WH, Neuzil KM, Boyce CR, Pasetti MF, Reymann MK, Martellet L, Hosken N, LaForce FM, Dhere RM, Pisal SS, Chaudhari A, Kulkarni PS, Borrow R, Findlow H, Brown V, McDonough ML, Dally L, Alderson MR. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine containing serogroups A, C, Y, W, and X in healthy adults: a phase 1, single-centre, double-blind, randomised, controlled study. Lancet Infect Dis. 2018 Oct;18(10):1088-1096. doi: 10.1016/S1473-3099(18)30400-6. Epub 2018 Aug 14.
• Castilla J, Cenoz MG, Barricarte A. Meningococcal Group B Vaccine (4CMenB) in Children. Reply. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available.
• Lopez-Lacort M, Munoz-Quiles C, Orrico-Sanchez A. Meningococcal Group B Vaccine (4CMenB) in Children. N Engl J Med. 2023 Jun 1;388(22):2109. doi: 10.1056/NEJMc2303518. No abstract available.
• Haidara FC, Umesi A, Sow SO, Ochoge M, Diallo F, Imam A, Traore Y, Affleck L, Doumbia MF, Daffeh B, Kodio M, Wariri O, Traore A, Jallow E, Kampmann B, Kapse D, Kulkarni PS, Mallya A, Goel S, Sharma P, Sarma AD, Avalaskar N, LaForce FM, Alderson MR, Naficy A, Lamola S, Tang Y, Martellet L, Hosken N, Simeonidis E, Welsch JA, Tapia MD, Clarke E. Meningococcal ACWYX Conjugate Vaccine in 2-to-29-Year-Olds in Mali and Gambia. N Engl J Med. 2023 May 25;388(21):1942-1955. doi: 10.1056/NEJMoa2214924.

Drugs

Indications