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Pfizer Presents Results from Two Phase 3 TRUMENBA® Studies

 

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Pfizer Inc. announced results of two Phase 3 studies demonstrating the immunogenicity of TRUMENBA® (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe. The two studies, one in adolescents and one in young adults, met all primary immunogenicity endpoints. Also, secondary data presented show that TRUMENBA demonstrated similar immune responses against ten additional MnB strains, in both adolescents and young adults. The data, which continue to support the vaccine’s current safety and tolerability profile, were presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016).

“TRUMENBA is designed to provide protection against serogroup B meningococcal disease,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “

In October 2014, TRUMENBA 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.

In 2015, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommended serogroup B meningococcal vaccination for certain persons aged 10 years and older at increased risk for meningococcal disease. They also recommended that a MnB vaccine series may be administered to adolescents and young adults 16 through 23 years of age (preferred age 16 through 18) to provide short term protection against most strains of MnB disease.

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