Novartis MenB vaccine trials meet primary endpoints

In a Phase IIb open-label trial evaluating infants at 2, 4, 6 months or at 2, 3, 4 months with or without routine vaccines, Bexsero demonstrated that the most of the infants vaccinated with Bexsero, at either dosing schedule with or without routine vaccines, achieved hSBA >= 1:5 against all vaccine antigens in tested MenB strains.

Additionally, the open-label Phase III trial of Bexsero investigating toddlers demonstrated that Bexsero provides protective immune response when used as a booster in toddlers already primed, or after two doses in those not previously vaccinated with Bexsero

In this open-label study, healthy toddlers not previously vaccinated with Bexsero either received MMR-V at 12 months followed by two doses of Bexsero at 13 and 15 months (alone), or MMR-V and Bexsero at 12 months and Bexsero at 14 months (concomitant).

The results from an observer-blind study of 11-17 year-old adolescents showed that one month after vaccination 92-97% of recipients of one Bexsero dose, 99-100% after two or three Bexsero doses and 29-50% of placebo recipients had hSBA titers >=4 against the three test strains.

Novartis Vaccines and Diagnostics Division head Andrin Oswald said the data show that Bexsero, their multicomponent MenB vaccine, holds great promise in providing a solution to a major public health concern that can have a devastating impact on vulnerable populations.