Pfizer announces results of two Phase III trials for Trumenba (meningococcal group B vaccine)
Pfizer announced positive topline results of two Phase III studies of Trumenba (meningococcal group B vaccine). One study included approximately 3,600 healthy individuals of 10–18 years of age, and the other study included approximately 3,300 healthy individuals of 18–25 years of age. Both studies met all primary immunogenicity endpoints, demonstrating robust immune responses against certain invasive meningococcal B strains after the vaccine dose series. Safety and tolerability data from both studies were also consistent with data from previous studies.
In October 2014, Trumenba was granted accelerated approval by the FDA for active immunisation to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10–25. Pfizer plans to present the full results of both studies at an upcoming scientific congress.