Pfizer achieved positive results from two Phase III studies of TRUMENBA (Meningococcal Group B Vaccine). Both studies met all primary immunogenicity endpoints, demonstrating immune responses against certain invasive meningococcal B strains. 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.
“We are very pleased with these Phase III 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 III 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, TRUMENBA was granted accelerated approval by the FDA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
