Pfizer Inc. announced positive top-line results of a phase 2 study of Trumenba (Meningococcal Group B Vaccine) co-administered with FDA-approved, routine meningococcal (groups A, C, Y and W) (MCV4) and single-dose tetanus, diptheria and pertussis (Tdap) vaccines in more than 2,600 healthy individuals 10 through 12 years of age. The study met its co-primary immunogenicity objectives regarding co-administration of Trumenba with MCV4 and Tdap vaccines.

In addition, data from a recently completed phase 3 study demonstrated the safety and tolerability of Trumenba in approximately 5,600 healthy individuals 10 through 25 years of age, and were consistent with data from studies that supported the October 2014 accelerated approval of Trumenba in the United States.

“These phase 3 data add to a growing body of evidence that support Trumenba as a well-tolerated vaccine,” says Dr. William Gruber, senior vice president of Vaccine Clinical Research and Development for Pfizer Inc. “Further, the results observed in our phase 2 study of Trumenba co-administered with other routine and recommended adolescent vaccines provide important evidence that we’ve shared with the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices to review as they consider recommendation of meningococcal B vaccination for adolescents and young adults.”

In October 2014, Pfizer’s Trumenba (Meningococcal Group B Vaccine) was granted accelerated approval by the US Food and Drug Administration (FDA) for active immunisation to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

These data have been shared with the FDA. Pfizer plans to present the full results of both studies at upcoming medical meetings in 2015.

Vaccine safety, tolerability and immunogenicity were evaluated in this phase 2, randomized, controlled, observer-blinded study of Trumenba in the US The study included more than 2,600 healthy individuals 10 through 12 years of age. Group 1 received Trumenba co-administered with MCV4 and Tdap vaccines; Group 2 received MCV4 and Tdap vaccines only; and Group 3 received Trumenba only. Co-primary objectives included:

Demonstration that the immune response induced by MCV4 and Tdap vaccines given with Trumenba was noninferior to the immune response induced by MCV4 and Tdap vaccines alone when measured one month after the first vaccination; and Demonstration that the immune response induced by Trumenba given with MCV4 and Tdap vaccines was noninferior to the immune response induced by Trumenba alone, when measured one month after the third vaccination with Trumenba.

Vaccine safety and tolerability were evaluated in this phase 3, randomised, controlled, double-blind study of Trumenba in the US, Europe, Australia and Chile. The study, which was initiated in November 2012, included approximately 5,600 healthy individuals assigned in a 2:1 ratio to receive Trumenba in a 0, 2, 6 month schedule or control. The control group received a licensed hepatitis A vaccine at month 0 and 6 and saline at month. Subjects were followed for six (6) months after the last vaccination to assess safety and tolerability. Primary endpoints included:

The percentage of individuals with one or more (=1) serious adverse event from the first study vaccination through six (6) months after the last study vaccination; and The percentage of individuals with one or more (=1) medically-attended adverse event within 30 days after each vaccination (at 1, 3 and 7 months).

The rate of adverse events following vaccination with Trumenba was compared to those occurring in the control group.

Trumenba (Meningococcal Group B Vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidisserogroup B in individuals 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.