Pfizer presents positive results in meningococcal disease late-stage trials
pharmafile | May 13, 2016 | News story | Research and Development | Pfizer, Vaccine, late stage trials, meningococcal disease
Pfizer (NYSE: PFE) has announced results from two pivotal late-stage trials demonstrating the immunogenicity of Trumenba against invasive meningococcal B (MnB) strains, representative of prevalent strains in the US and Europe.
Evaluated in both adult and paediatric patients, both studies reached their primary immunogenicity endpoints. The secondary data also showed that Trumenba showed similar immune responses against 10 additional strains of MnB.
Meningococcal disease is a disease that may result in life-altering, significant long-term and permanent medical disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.
The data was presented at the European Society for Paediatric Infectious Diseases Meeting. It is expected that the efficacy observed in these trials will form the basis of upcoming global regulatory submissions and the planned US supplement to request the conversion of accelerate approval to traditional approval for Trumenba.
Kathrin Jansen, head of vaccine research and development for Pfizer, says: “Trumenba is designed to provide protection against serogroup B meningococcal disease. The Phase III data show that Trumenba elicits an immune response that is effective against prevalent meningococcal serogroup B strains in the US and Europe, as well as 10 additional strains of this unpredictable disease. These data support the expectation that vaccination with Trumenba will help prevent this uncommon, but devastating disease in adolescents and young adults.”
Sean Murray
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