Phase III trial of MenABCWY pentavalent meningococcal vaccine meets primary endpoints and is set for BLA

The trial met all primary and secondary endpoints, with the investigational vaccine demonstrating non-inferiority to licensed vaccines for the five meningococcal serogroups that cause the majority of invasive meningococcal disease: serogroups A, B, C, W and Y. Currently, MenACWY and MenB vaccines are licensed separately, and no single vaccine is available to help protect against the five serogroups.

Participants in the trial were randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba + one dose of Menveo). Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba and one dose of Menveo. Additionally, a single dose of MenABCWY met the non-inferiority criteria for serogroups A, C, W and Y compared to one dose of Menveo. Furthermore, in individuals who had not previously received a meningococcal vaccine, the proportion of subjects with at least 4-fold increases in immune responses was observed to be higher following either one or two doses of MenABCWY for serogroups A, C, W and Y compared to one dose of Menveo. Finally, the proportion of subjects with at least 4-fold increases in immune responses was also observed to be higher against all four serogroup B strains following two doses of MenABCWY compared to two doses of Trumenba. The pentavalent vaccine candidate was well-tolerated, with a safety profile consistent with licensed vaccines.

Based on these Phase III results, which meet pre-determined criteria for licensure, Pfizer intends to submit a Biologics License Application to the FDA in the fourth quarter of this year. Submissions to additional regulatory authorities outside the U.S. are also planned. MenABCWY, which is a combination of Trumenba and a former GSK vaccine called Nimenrix, was sold to Pfizer in 2015.