Successful Phase III trials for adolescents and young adults for Trumenba vaccine for meningococcal B (MnB) disease.- Pfizer

Pfizer Inc. announced results of two Phase III 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).

One Phase III study was a randomized, active-controlled, observer-blinded study that included approximately 3,600 healthy individuals 10 through 18 years of age in the U.S. and Europe. Individuals were randomized to receive one of three different lots of Trumenba in a 0, 2, 6 month schedule or a control, licensed hepatitis A (HAV) vaccine, at 0 and 6 months and saline at 2 months. Immune responses were assessed by serum bactericidal assays using human complement (hSBA). The study primary endpoint assessed the percentage of subjects with a response to four primary MnB test strains (N=1210-1266), representative of prevalent MnB strains, and the secondary endpoint assessed responses to 10 additional MnB test strains in a population subset (N=266-281).The hSBA responses one month after doses 2 and 3 against the four primary MnB test strains as defined by hSBA responses were 64.0%-99.1% and 87.1%-99.5%, respectively. As these four primary strains are representative, they predict the ability of antibodies elicited by Trumenba to be active against diverse circulating strains. The hSBA responses to the 10 additional MnB test strains were 61.1%-100.0% and 75.1%-98.6% one month after dose 2 and 3, respectively. These data were presented in an oral session at the ESPID meeting.

A second Phase III study was a randomized, placebo-controlled, observer-blinded study that included approximately 3,300 healthy individuals 18 through 25 years of age in the U.S. and Europe. Individuals were randomized to receive Trumenba in a 0, 2, 6 month schedule or a saline control. Immune responses were assessed by serum bactericidal assays using hSBAs. The study primary endpoint assessed the percentage of subjects with a response to four primary MnB test strains (N=1702-1714), representative of prevalent MnB strains, and the secondary endpoint assessed responses to 10 additional MnB test strains in a population subset (N=273-284). The hSBA responses one month after dose 2 and 3 among Trumenba recipients against the four primary MnB test strains as defined by hSBA responses were 68.3%-97.4% and 87.4%-99.4%, respectively. As these four primary strains are representative, they predict the ability of antibodies elicited by Trumenba to be active against diverse circulating strains. The hSBA responses to the 10 additional MnB test strains were 51.6%-97.9% and 71.3%-99.3% one month after dose 2 and 3, respectively. Safety and tolerability were also evaluated. Local and systemic reactions were reported more commonly with Trumenba. Reactogenicity events were mostly mild to moderate in severity and of short duration. Injection site pain (89.6%) and fatigue (64.6%) were the most common local and systemic reactions with Trumenba, respectively. Adverse events were generally similar for the two study groups.

Comment: Trumenba has accelerated approval in the US.