GSK plc. (GSK.L,GSK) announced positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate. MenABCWY combination vaccine candidate met all 11 primary endpoints of the trial. If approved, the 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and could lead to a simplified immunisation schedule.
The phase III trial, dubbed as NCT04502693, evaluated the safety, tolerability, and immunogenicity of its MenABCWY combination vaccine candidate, administered as two doses given six months apart in healthy individuals aged 10-25 years.
According to GSK, MenABCWY vaccine candidate combines the antigenic components of its licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). All primary endpoints were met, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups (A, B, C, W, and Y) compared to licensed meningococcal vaccines Bexsero and Menveo in terms of an immune response. In addition, the vaccine candidate was well tolerated, with a safety profile consistent with Bexsero and Menveo.
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