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.
Phase 3 Study Designs
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
TRUMENBA® (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.
Important Safety Information
TRUMENBA® should not be given to anyone with a history of a severe allergic reaction after a previous dose of TRUMENBA.
Individuals with weakened immune systems may have a reduced immune response.
The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills.
Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series.
Tell your healthcare provider if you are pregnant, or plan to become pregnant.
Ask your healthcare provider about the risks and benefits of TRUMENBA. Only a healthcare provider can decide if TRUMENBA is right for you or your child.
You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.
For the full prescribing information for TRUMENBA, please visit www.trumenba.com.