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Positive Results Reported for Meningococcal Vaccine Trumenba

Phase III studies meet primary endpoints

Encouraging results have been reported from two phase III trials of Trumenba (meningococcal group B vaccine, Pfizer). One study included approximately 3,600 healthy individuals 10 through 18 years of age, and the other study included approximately 3,300 healthy individuals 18 through 25 years of age. Both studies met all primary immunogenicity endpoints, demonstrating robust immune responses against certain invasive meningococcal B strains after the vaccine dose series.

In October 2014, the FDA granted Trumenba accelerated approval for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. The effectiveness of Trumenba against diverse serogroup-B strains has not been confirmed.

The vaccine’s safety and immunogenicity has been evaluated in two pivotal phase III studies.

One study was a randomized, active-controlled, observer-blinded trial that included approximately 3,600 healthy individuals 10 through 18 years of age in the U.S. and Europe. The subjects were randomly assigned to receive one of three different lots of Trumenba in a 0-, 2-, and 6-month schedule or a control. The control group received a licensed hepatitis A vaccine at 0 and 6 months and saline at 2 months. The study’s primary endpoints assessed immunogenicity, lot consistency, and safety. The study’s immunogenicity endpoint consisted of the demonstration of an immune response measured by serum bactericidal assays with human complement (hSBA) for four primary test strains 1 month after the third vaccination with Trumenba.

A second phase III study was a randomized, placebo-controlled, observer-blinded trial that included approximately 3,300 healthy individuals 18 through 25 years of age in the U.S. and Europe. The subjects were randomly assigned to receive Trumenba or a saline control in a 0-, 2-, and 6-month schedule. The primary endpoints assessed immunogenicity and safety. The immunogenicity endpoint was the demonstration of an immune response measured by hSBA for four primary test strains 1 month after the third vaccination with Trumenba.

Source: Pfizer; August 21, 2015.

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