2023-03-15| Trials & Approvals

GSK’s Meningococcal Combination Vaccine Clears All Primary Endpoints In Phase 3

by Joy Lin
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GSK has revealed positive results from the Phase 3 trial of its MenABCWY combination vaccine candidate, putting it one step closer to a planned regulatory filing. 

GSK’s MenABCWY vaccine combines the antigenic parts of its licensed meningococcal vaccines Bexsero (MenB) and Menveo (MenACWY), conferring protection to all five Neisseria meningitides serogroups A, B, C, W, and Y. It is given in two doses spaced six months apart in healthy participants aged 10-25 years. 

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Combination Vaccine Achieves All 11 Primary Endpoints in Phase 3

Invasive meningococcal disease (IMD) is a major cause of meningitis and sepsis. While uncommon, it can be serious enough to cause death, typically amongst healthy children and adolescents. Even when victims survive, they might suffer long-term consequences ranging from nervous system problems to amputations. 

GSK has been pushing for a combination vaccine that could guard against the five N. meningitides serogroups that account for nearly all IMD cases globally. In the US, two separate vaccines which require four injections are required to receive full protection. This immunization regimen, coupled with low awareness of the disease, may lead to inadequate coverage rates, said GSK. If its MenABCWY combination vaccine is approved, it could lead to a simplified immunization schedule while providing the broadest serogroup coverage. 

In the MenABCWY Phase 3 trial, which enrolled around 3,650 individuals from around the world, the 5-in-1 vaccine candidate met all 11 primary endpoints and demonstrated statistical non-inferiority compared to Bexsero and Menveo. Safety-wise, the candidate was similar to Bexsero and Menveo. 

“These statistically significant Phase 3 data are a very encouraging step toward reducing the incidence of meningococcal disease,” said Tony Wood, Chief Scientific Officer at GSK. 

“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. In addition, our 5-in-1 meningococcal vaccine candidate builds on our global leadership in meningococcal vaccines and commitment to innovation.”

The full Phase 3 data will be reviewed with regulators, which could support the supplemental Biologics License Application for Bexsero. This is because the trial serves as both Bexsero’s confirmatory trial and the Phase 3 trial for MenABCWY. Detailed results will be presented in a peer-reviewed publication and at future scientific meetings.  

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