Dengue fever vaccine Phase III results published in The Lancet-Sanofi Pasteur

Sanofi Pasteur, the vaccines division of Sanofi has announced the publication in The Lancet of the detailed results of its first landmark phase III Dengue vaccine efficacy study conducted in five countries in Asia. Results show overall efficacy against symptomatic Dengue of 56.5% in children aged 2 to 14 years old after a three-dose vaccination schedule. Importantly, analyses show an 88�5% reduction of Dengue haemorrhagic fever, the severe form of Dengue,according to the WHO 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 (phase I, II, IIb).

See-"Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial"-Maria Rosario Capeding MD, Prof Ngoc Huu Tran MD, Prof Sri Rezeki S Hadinegoro MD, Hussain Imam HJ Muhammad Ismail FRCPCH, Tawee Chotpitayasunondh MD, Mary Noreen Chua MD and others-The Lancet, Early Online Publication, 11 July 2014 doi:10.1016/S0140-6736(14)61060-6.