Positive Phase 3 Results for Meningococcal Group B Vaccine
Pfizer announced positive topline results of two Phase 3 studies of Trumenba (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B.
The first study, a randomized, active-controlled, observer-blinded trial, included approximately 3,600 healthy individuals aged 10–18 years who received 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. A second randomized, placebo-controlled, observer-blinded study, included approximately 3,300 healthy individuals aged 18–25 years. Individuals were randomized to receive Trumenba or a saline control in a 0, 2, 6 month schedule. Both studies met all primary immunogenicity endpoints, demonstrating robust immune responses against certain invasive meningococcal B strains after the vaccine dose series.
In October 2014, Trumenba was granted accelerated approval by the Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10–25 years.
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