Pfizer Presents Results from Two Phase 3 TRUMENBA Studies at the European Society for Paediatric Infectious Diseases Meeting

Pfizer Inc.

today announced results of two Phase 3 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). "TRUMENBA is designed to provide protection against serogroup B meningococcal disease," said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. "The Phase 3 data show that TRUMENBA elicits an immune response that is effective against prevalent meningococcal serogroup B strains in the U.S. 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." These Phase 3 data support additional upcoming global regulatory submissions and the planned U.S. supplement to request the conversion of Accelerated Approval to Traditional Approval for TRUMENBA. In October 2014, TRUMENBA was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. In 2015, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) recommended serogroup B meningococcal vaccination for certain persons aged 10 years and older at increased risk for meningococcal disease.1 They also recommended that a MnB vaccine series may be administered to adolescents and young adults 16 through 23 years of age (preferred age 16 through 18) to provide short term protection against most strains of MnB disease.2 Phase 3 Study in Adolescents One Phase 3 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 (titers ≥LLOQ) 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. 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 (median, 1-2 days). Injection site pain (92.6%) and headache (67.1%) were the most common local and systemic reactions with TRUMENBA, respectively. Adverse events were generally similar between the two study groups. Phase 3 Study in Young Adults A second Phase 3 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 (titers ≥LLOQ) 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 (median, ≤3 days). 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. TRUMENBA is currently approved in the U.S. Indication for TRUMENBA in the U.S. TRUMENBA (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed. Important Safety Information TRUMENBA® should not be given to anyone with a history of a severe allergic reaction after a previous dose of TRUMENBA. Individuals with weakened immune systems may have a reduced immune response. The most common adverse reactions were pain at the injection site, fatigue, headache, muscle pain, and chills. Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series. Tell your healthcare provider if you are pregnant, or plan to become pregnant. Ask your healthcare provider about the risks and benefits of TRUMENBA. Only a healthcare provider can decide if TRUMENBA is right for you or your child. For the full prescribing information for TRUMENBA, please visit www.trumenba.com.