Pfizer has 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.

“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 III 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 III 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 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. 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.

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 zero, two, six month schedule or a control, licensed hepatitis A (HAV) vaccine, at zero and six months and saline at two 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, 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.

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 zero, two, six 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.