Pfizer announced Tuesday positive top-line results of a Phase 2 study of TRUMENBA®(Meningococcal Group B Vaccine) co-administered with FDA-approved, routine meningococcal (groups A, C, Y and W) (MCV4) and single-dose tetanus, diptheria and pertussis (Tdap) vaccines in more than 2,600 healthy individuals 10 through 12 years of age. The study met its co-primary immunogenicity objectives regarding co-administration of TRUMENBA with MCV4 and Tdap vaccines.
In addition, data from a recently completed Phase 3 study demonstrated the safety and tolerability of TRUMENBA in approximately 5,600 healthy individuals 10 through 25 years of age, and were consistent with data from studies that supported the October 2014 accelerated approval of TRUMENBA in the United States.
“These Phase 3 data add to a growing body of evidence that support TRUMENBA as a well-tolerated vaccine,” said Dr. William Gruber, senior vice president of Vaccine Clinical Research and Development for Pfizer Inc. “Further, the results observed in our Phase 2 study of TRUMENBA co-administered with other routine and recommended adolescent vaccines provide important evidence that we’ve shared with the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to review as they consider recommendation of meningococcal B vaccination for adolescents and young adults.”
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.