Pfizer, Inc., said Tuesday that top-line results from a Phase 2 study of TRUMENBA, a meningococcal group B vaccine, administered with U.S. Food and Drug Administration (FDA) approved routine meningococcal and diphtheria, pertussis and tetanus vaccines in adolescents are positive.
The vaccines were administered to 2,600 healthy adolescents between the ages of 10 and 12. The study met its co-primary immunogenicity objectives about co-administration of TRUMENBA with routine meningococcal, diphtheria, pertussis and tetanus vaccines.
In addition, a Phase 3 study has demonstrated the safety and tolerability of TRUMENBA in individuals between the ages of 10 and 25.
“These Phase 3 data add to a growing body of evidence that support TRUMENBA as a well-tolerated vaccine,” Pfizer Senior Vice President of Vaccine Clinical Research and Development William Gruber said. “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.”
Pfizer’s TRUMENBA was granted accelerated approval by the FDA in October 2014 to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.