GSK Achieves Primary Endpoints Meningococcal ABCWY Vaccine for Phase 3 Trial
If FDA approved, this 5-in-1 investigational candidate could provide the broadest meningococcal serogroup coverage.
GSK announced this week that its meningococcal MenABCWY combination vaccine candidate met all 11 primary endpoints of its phase 3 clinical trial.
The vaccine was administered to participants in 2 doses at six months apart in healthy individuals between the ages of 10-25 years old.
“These statistically significant phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease. In the US, routine use of a 5-in-1 meningococcal vaccine with a two-dose regimen in adolescents at 16 to 18 years of age, just before this disease’s incidence peak, could drive significant public health impact,” GSK Chief Scientific Officer Tony Wood, PhD, said in a statement.
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.
The phase 3 trial randomized, 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 program to generate clinical evidence on the benefits of meningococcal immunization. The trial had approximately 3650 participants aged 10-25 were enrolled in the US, Canada, Czech Republic, Estonia, Finland, Turkey, and Australia.
GSK is working closely with regulators to review the full phase 3 data set, including the supplemental Biologics License Application (BLA) for Bexsero. This clinical trial was both the confirmatory trial for Bexsero and the phase 3 trial for MenABCWY. According to GSK, results from this phase 3 trial will be presented in a peer-reviewed publication and at upcoming scientific meetings
