The data from this Phase II clinical study, which is still being analyzed, shows that the vaccine was immunogenic and met the predefined criterion of an overall immune response rate of greater than 50%, with 95% confidence. It induced significantly higher antibody concentrations, indicative of systemic responses, in children in the vaccine group compared to the placebo control group.
The vaccine was well tolerated with no serious adverse events or deaths reported, and no subjects withdrew due to adverse events. There were no statistical differences in the incidence of adverse events between the vaccinated and placebo treated groups.
Fuad El-Hibri, chairman and CEO, said: “We are very pleased to have met the objectives of this Phase II study of our typhoid vaccine candidate. This data is encouraging and indicates great promise for what would be the first single-dose, drinkable typhoid vaccine.”