Clinical Trials

Date: 2017-12-13

Type of information: Publication of results in a medical journal

phase: 3

Announcement: publication of results in The New English Journal of Medicine

Company: Pfizer (USA - NY)

Product: Trumenba® - rLP2086 coadministered with routine meningococcal (groups A, C, Y and W) (MCV4) and tetanus, diphtheria and pertussis (Tdap) vaccines

Action mechanism:

• vaccine. This investigational meningococcal B vaccine targets LP2086, or factor H binding protein, which is found on the surface of the meningococcal B bacterium. The gene for factor H binding protein is present in more than 1,800 meningococcal B isolates studied by Pfizer researchers. The vaccine contains two recombinant versions of the LP2086 antigen, one representative for each of the two known genetic subfamilies of the antigen, subfamily A and subfamily B.
• Trumenba®(Meningococcal Group B Vaccine) is indicated in the US for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. In 2014, this vaccine was reviewed and received accelerated approval under the FDA's Breakthrough Therapy designation and Priority Review programs.

Disease:

Therapeutic area:

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Trial details:

• The two Phase 3 randomized, controlled, multicenter clinical trials, which were previously presented at the 34th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID 2016), included nearly 7,000 healthy adolescents and young adults, 10 to 18 years of age and 18 to 25 years of age, respectively, in the U.S., Europe, and Canada.
• Immune responses in both studies were assessed by serum bactericidal assays using human complement (hSBA). The primary immunogenicity objectives assessed the immune responses to four primary MenB test strains representative of prevalent MenB strains one month after dose three. The secondary endpoint measured responses to 10 additional diverse, disease?causing MenB test strains.

 

Latest news:

• • On December 13, 2017, Pfizer announced that detailed results from two pivotal Phase 3 studies of Trumenba® (Meningococcal Group B Vaccine) were published in the New England Journal of Medicine (NEJM). Data from both studies demonstrated that Trumenba®, as a three-dose series, elicits a protective immune response against diverse meningococcal group B (MenB) strains representative of prevalent strains causing invasive disease in the United States and Europe. These studies met all five co-primary immunogenicity endpoints against a panel of diverse test strains.
• The proportion of adolescents (n=2571) achieving ?4-fold increases in hSBA titers against each primary strain after dose three was 78.8% to 90.2%; responses in young adults (n=2169) were 78.9% to 89.7%. Composite responses, the proportion of subjects that achieved a prespecified hSBA titer for all four primary strains, were 82.7% in adolescents and 84.5% in young adults after dose three. The responses to the 10 additional strains were comparable to those seen against the four primary strains. The most common solicited adverse reactions in adolescents and young adults were pain at injection site, fatigue, headache, and muscle pain.
• These published data are now available for vaccine technical committees and other public health authorities to review as they evaluate recommendations for the use of Trumenba® in adolescents and young adults.

Is general: Yes