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Sanofi Pasteur releases positive results from Phase III dengue vaccine trial

Sanofi Pasteur has released positive results of its first Phase III dengue vaccine efficacy trial carried out in five countries in Asia.

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.

A total of 10,275 children aged two to 14 years from dengue endemic areas of Indonesia, Malaysia, the Philippines, Thailand and Vietnam participated in the trial from 2011-2013.

In the randomized, observer-blind, placebo-controlled multicenter trial patients were randomised to either receive three injections of the dengue vaccine or a placebo (2 to 1 ratio) at 6-month intervals.

The trial’s primary endpoint was measured by the number of symptomatic virologically-confirmed dengue cases caused by any serotype.

Analyses of the trial show an 88.5% reduction of dengue haemorrhagic fever, the severe form of dengue, according to the World Health Organization (WHO) criteria.

The Phase III trial also showed a clinically important reduction in the risk of hospitalization due to dengue by 67%.

The company said that the vaccine is also expected to reduce the risk of hospitalisation due to dengue by two-thirds.