Pfizer releases positive Phase II trial results of meningococcal B vaccine

According to the company, in both the trials ‘bivalent rLP2086’ was observed to generate bactericidal responses, a measurement of functional immune response, against diverse meningococcal serogroup B test strains following either two or three doses.

Moreover, in the trial evaluating co-administration of bivalent rLP2086 and a diphtheria, tetanus, pertussis and inactivated polio vaccine (dTaP-IPV), no impact was observed on the immune response to the dTaP-IPV vaccine.

Pfizer senior vice president of Vaccine Research and Development Emilio Emini said disease caused by meningococcus serogroup B is serious and unpredictable.

"The disease is difficult to recognize early and progresses rapidly, making preventive vaccination especially important," Emini said.

"We are encouraged by the safety and tolerability data for our investigational vaccine candidate, bivalent rLP2086, and its potential to help prevent this devastating disease.

"We look forward to continuing the development of this critically-needed vaccine and working with regulatory authorities to make it available to adolescents and young adults."

The first Phase II, randomized, placebo-controlled, single-blind trial assessed the safety, tolerability and immunogenicity of bivalent rLP2086 in healthy adolescents aged 11 to 18 years in two- and three-dose schedules.

The second randomised, placebo-controlled Phase II trial evaluated the effects of co-administration of bivalent rLP2086 with a dTaP-IPV vaccine in healthy adolescents aged 11 to 18 years.

Pfizer is carrying out a global clinical development program for bivalent rLP2086, which includes both Phase II and Phase III trials evaluating over 20,000 participants, about 14,000 of whom will receive the investigational vaccine.