The FINANCIAL — Pfizer Inc. announced on August 21 positive topline results of two Phase 3 studies of TRUMENBA (Meningococcal Group B Vaccine).
One study included approximately 3,600 healthy individuals 10 through 18 years of age, and the other study included approximately 3,300 healthy individuals 18 through 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, according to Pfizer.
“We are very pleased with these Phase 3 data that show immunogenicity and safety data consistent with findings that formed the basis for the accelerated FDA approval of TRUMENBA,” said Kathrin Jansen, Ph.D., senior vice president of Vaccine Research and Development for Pfizer Inc. “The Phase 3 data extend the body of evidence that supports vaccination of adolescents and young adults with TRUMENBA to help prevent serogroup B meningococcal disease.”
In October 2014, Pfizer’s TRUMENBA (Meningococcal Group B Vaccine) was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Pfizer plans to present the full results of both studies at an upcoming scientific congress.