OREANDA-NEWS. Pfizer Inc. (NYSE:PFE) announced today 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.

“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.

Vaccine safety and immunogenicity were evaluated in these two Phase 3 studies.

One Phase 3 study was a randomized, active-controlled, observer-blinded study that included approximately 3,600 healthy individuals 10 through 18 years of age in the United States and Europe. Individuals were randomized to receive one of three different lots of TRUMENBA® in a 0, 2, 6 month schedule or a control. The control group received a licensed hepatitis A (HAV) vaccine at 0 and 6 months and saline at 2 months. The primary endpoints assessed immunogenicity, lot consistency and safety.

  • Immunogenicity: Demonstration of an immune response measured by serum bactericidal assays with human complement (hSBA) for 4 primary test strains 1 month after the third vaccination with TRUMENBA
  • Lot consistency: hSBA geometric mean titers (GMTs) for 2 primary test strains (A22 and B24) measured 1 month after the third vaccination for individuals receiving one of three different lots of TRUMENBA
  • Safety: Proportion of subjects who reported local and systemic reactions, adverse events (AE), serious adverse events (SAE), newly diagnosed chronic medical conditions (NDCMC), medically-attended adverse events (MAE), autoimmune diseases and neuroinflammatory conditions following vaccination with TRUMENBA or a control

A second Phase 3 study was a randomized, placebo-controlled, observer-blinded study that included approximately 3,300 healthy individuals 18 through 25 years of age in the United States and Europe. Individuals were randomized to receive TRUMENBA® or a saline control in a 0, 2, 6 month schedule. The primary endpoints assessed immunogenicity and safety.

  • Immunogenicity: Demonstration of an immune response measured by hSBA for 4 primary test strains 1 month after the third vaccination with TRUMENBA
  • Safety: Proportion of subjects who reported local and systemic reactions, AEs, SAEs, NDCMCs, MAEs, autoimmune diseases and neuroinflammatory conditions following vaccination with TRUMENBA or placebo