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.