Protection against diverse meningococcal group B (MenB)

Pfizer Inc. announced that detailed results from two pivotal Phase III studies Meningococcal Group B Vaccine were published in the New England Journal of Medicine (NEJM). Data from both studies demonstrated that Trumenba, as a three-dose series, elicits a protective immune response against diverse meningococcal group B (MenB) strains representative of prevalent strains causing invasive disease in the United States and Europe. These studies met all five co-primary immunogenicity endpoints against a panel of diverse test strains. Early symptoms of meningococcal disease can be misinterpreted as the flu, often making it difficult to diagnose and delaying treatment; however, it is a serious disease that can lead to death within 24 hours. The most common clinical presentations of meningococcal disease are meningitis and septicemia. Up to one quarter of adolescents may be asymptomatic carriers of Neisseria meningitidis. These published data are now available for vaccine technical committees and other public health authorities to review as they evaluate recommendations for the use of Trumenba in adolescents and young adults.

About the Phase III Studies- The two Phase III randomized, controlled, multicenter clinical trials, which were previously presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016), included nearly 7,000 healthy adolescents and young adults, 10 to 18 years of age and 18 to 25 years of age, respectively, in the U.S., Europe, and Canada. In the studies, Trumenba, administered on a three-dose schedule (0, 2, and 6 months), demonstrated immunogenicity against four primary MenB strains representative of strains causing invasive disease. Immune responses in both studies were assessed by serum bactericidal assays using human complement (hSBA). The primary immunogenicity objectives assessed the immune responses to four primary MenB test strains representative of prevalent MenB strains one month after dose three. The secondary endpoint measured responses to 10 additional diverse, disease causing MenB test strains. The proportion of adolescents (n=2571) achieving greater than 4-fold increases in hSBA titers against each primary strain after dose three was 78.8% to 90.2%; responses in young adults (n=2169) were 78.9% to 89.7%. Composite responses, the proportion of subjects that achieved a prespecified hSBA titer for all four primary strains, were 82.7% in adolescents and 84.5% in young adults after dose three. The responses to the 10 additional strains were comparable to those seen against the four primary strains. The most common solicited adverse reactions in adolescents and young adults were pain at injection site, fatigue, headache, and muscle pain.

Comment: Trumenba has accelerated approval in the US and approval in the EU.