Pfizer Shows Off TRUMENBA Data from Two Large-Scale Phase III Trials

Pfizer Shows Off TRUMENBA Data from Two Large-Scale Phase III Trials May 13, 2016
By Mark Terry, Breaking News Staff

Pfizer , headquartered in New York, announced positive results from two Phase III studies of its Trumenba Meningococcal Group B vaccine. One study was in adolescents and the other was in young adults.

Secondary data also indicated that Trumenba showed similar immune responses against 10 more MnB strains in both study groups.

“Trumenba is designed to provide protection against serogroup B meningococcal disease,” said Kathrin Jansen, senior vice president and head of Vaccine Research and Development for Pfizer, in a statement. “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.”

Meningococcal disease has a variable incidence rate, ranging from less than 0.5 cases per 100,000 in North America and just under one case per 100,000 in Europe, but 10 to 1,000 cases per 100,000 during epidemic years in Africa. Most cases are the results of six Neisseria meningitidis serogroups, A, B, C, W-135, X and Y.

Serogroup B is not limited by age and is responsible for most incidents of the disease in Europe. It has potential life-altering, long-term effects, including possible brain damage, hearing loss, learning disabilities, and limb amputations.

The Phase III study in adolescents looked at about 3,600 healthy patients ages 10 through 18 in the U.S. and Europe. Immune responses after the second and third doses against the four primary test strains were 64 to 99.1 percent and 87.1 to 99.5 percent, respectively. Against the 10 other MnB strains, immune responses were 61.1 percent to 100 percent, and 75.1 to 98.6 percent, respectively.

The Phase III study in adults, ages 18 through 25 years, included 3,300 participants. Immune responses to dose two and three against the four primary strains were 68.3 percent to 97.4 percent in the dose two group, and 87.4 to 99.4 percent in the dose three group. For the additional 10 strains, immune response was 51.6 to 97.9 percent and 71.3 and 99.3 percent, respectively.

The vaccine, currently approved in the U.S., is a suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B. One is from fHBP subfamily A and the other is from subfamily B (A05 and B01, respectively).

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