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Studies Show Trumenba’s Efficacy Against Meningococcal Group B Strains

Pfizer presents data from two phase 3 vaccine trials

The results of two phase 3 studies demonstrate the immunogenicity of Trumenba (meningococcal group B vaccine) against invasive meningococcal B (MnB) strains representative of prevalent strains in the U.S. and Europe, Pfizer Inc. has announced.

 The two studies—one in adolescents and one in young adults—met all primary immunogenicity endpoints. Secondary data show that Trumenba demonstrated similar immune responses against 10 additional MnB strains in both adolescents and young adults. The data, which continue to support the vaccine’s safety and tolerability profile, were presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016).

“These data support the expectation that vaccination with Trumenba will help prevent this uncommon but devastating disease in adolescents and young adults,” said Kathrin Jansen, PhD, Senior Vice President and Head of Vaccine Research and Development for Pfizer Inc.

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 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 Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) recommended serogroup B meningococcal vaccination for certain persons ages 10 years and older at increased risk for meningococcal disease. ACIP also recommended that an 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.

Phase 3 Study in Adolescents

One phase 3, randomized, active-controlled, observer-blinded study 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 zero-, two-, and six-month schedule, or a control, licensed hepatitis A vaccine at zero and six months and saline at two months. Immune responses were assessed by serum bactericidal assays using human complement (hSBA). The 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 two and three against the four primary MnB test strains as defined by hSBA responses (titers at or above the lower limit of quantification [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 two and three, 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, one to two 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 phase 3, randomized, placebo-controlled, observer-blinded study 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 zero-, two-, and six-month schedule or a saline control. Immune responses were assessed by serum bactericidal assays using hSBAs. The 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 two and three among Trumenba recipients against the four primary MnB test strains as defined by hSBA responses (titers at or above 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 two and three, 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, three days or less). 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.

Source: Pfizer; May 13, 2016.

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