Phase 3 Studies Show Effectiveness of Pfizer’s Meningitis Vaccine
Pfizer has released positive topline results of two Phase 3 studies of its meningitis vaccine Trumenba, saying its ability to provoke an immune response and safety data are consistent with the findings that formed the basis for its FDA accelerated approval.
One study included about 3,600 healthy individuals 10 to 18 years old, while the other had roughly 3,300 healthy adults ages 18 to 25. Both met all primary immunogenicity endpoints, demonstrating strong immune responses against four invasive meningococcal B strains, Pfizer says. The safety and tolerability data were also consistent with that from previous studies.
The control group in the first study received a licensed hepatitis A vaccine, while controls in the second study got a placebo.
The FDA approved Trumenba last October to prevent meningococcal disease caused by Neisseria meningitidis serogroup B in patients ages 10 to 25. — Kellen Owings