Sanofi Pasteur releases pivotal Ph III results from dengue vaccine study

Sanofi Pasteur, the vaccines division of French drug major Sanofi (Euronext: SAN), has announced detailed results of its first landmark Phase III dengue vaccine efficacy study conducted in five countries in Asia.

Published in The Lancet, the results show overall efficacy against symptomatic dengue of 56.5% in children aged two to 14 years old after a three-dose vaccination schedule. Analyses show an 88·5% reduction of dengue haemorrhagic fever, the severe form of dengue, according to the World Health Organization criteria. The study also showed a clinically important reduction in the risk of hospitalization due to dengue by 67% during the study. The favorable vaccine safety profile observed during the 25 month follow up of the Phase III study in Asia is consistent with the safety profile documented in other studies.

John Shiver, senior vice president, R&D at Sanofi Pasteur, said: “These pivotal phase III vaccine efficacy study results take us closer to our ambition to bring the first vaccine against dengue to the world. After more than 20 years of commitment in collaboration with the scientific community, we are on course to make dengue the next vaccine-preventable disease. The public-health implications of a future dengue vaccine are significant and these findings are an important stride towards meeting the WHO's strategic goals of reducing dengue mortality by half and morbidity by at least 25% by 2020."