Therapy Areas: Vaccines
Pfizer reports positive results in trial of pentavalent meningococcal vaccine candidate
15 September 2022 -

US pharmaceutical company Pfizer Inc (NYSE:PFE) reported on Thursday positive top-line results from the pivotal Phase 3 trial of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals aged between 10 and 25 years.

The trial is designed to assess the safety, tolerability and immunogenicity of MenABCWY, with participants randomly assigned to receive either two doses of MenABCWY or licensed vaccines (two doses of Trumenba + one dose of Menveo).

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.

Results also shows that the investigational vaccine was well-tolerated with an acceptable safety profile and immunogenicity non-inferior to Trumenba + Menveo for all serogroups.

Based on the findings, Pfizer plans to submit an application for approval to the US Food and Drug Administration in the fourth quarter of 2022. Submissions to regulatory authorities in other countries are also planned.

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