Phase III trial of MenABCWY pentavalent vaccine meets all primary endpoints in meningococcal disease.- GSK
GSK announced positive headline results from the phase III trial (NCT04502693) evaluating 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.
GSK’s 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.
Five Neisseria meningitides serogroups (A, B, C, W, and Y) account for nearly all IMD cases in most of the world. As yet, no licensed combination vaccine offers protection against these serogroups in a single vaccine. Currently, in the US, two separate vaccines needing four injections are required to protect against all five serogroups. This immunisation regimen, coupled with low awareness of the disease, can lead to sub-optimal immunisation coverage rates, particularly for MenB, with an estimated coverage of only approximately 31% of adolescents in the US. GSK is working closely with regulators to review the full phase III data set, including the supplemental Biologics License Application for Bexsero. This clinical trial was both the confirmatory trial for Bexsero and the phase III trial for MenABCWY. Detailed results from this phase III trial will be presented in a peer-reviewed publication and at upcoming scientific meetings.
The trial conducted by GSK is a phase III randomised, controlled, observer-blind, multi-country trial to evaluate the safety, tolerability, and immunogenicity of GSK’s MenABCWY vaccine candidate. It is part of a comprehensive programme to generate clinical evidence on the benefits of meningococcal immunisation. The trial started in August 2020, and approximately 3,650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia. The objective of the trial was to assess the safety profile of the MenABCWY vaccine candidate and to compare the immune responses of the trial’s participants who received two doses of the MenABCWY vaccine candidate six months apart to the responses of those in the control groups who received GSK’s licensed vaccines, Bexsero (MenB) and Menveo (MenACWY).
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