By RTT News,
July 11, 2014, 12:44:00 AM EDT
(RTTNews.com) - French drug maker Sanofi's (SNYNF, SNY) Sanofi Pasteur division Friday 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 percent in children aged 2 to 14 years after a three-dose vaccination schedule.
Analyses show an 88Â·5 percent 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 percent during the study.
The Phase III clinical study conducted in Asia is a randomized, observer-blind, placebo-controlled multicenter trial.
A total of 10,275 children aged 2 to 14 years from dengue endemic areas of Indonesia, Malaysia, the Philippines, Thailand and Vietnam participated in the study from 2011-2013. They were randomized to either receive three injections of the dengue vaccine or a placebo at 6-month intervals.
The primary endpoint was measured by the number of symptomatic virologically-confirmed dengue cases caused by any serotype.
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.
Safety analyses, which include solicited reactions, unsolicited events and Serious Adverse Events or SAEs, during the study showed similar reporting rates between the vaccine and control groups.
SAEs were consistent with medical disorders in this age group and were mainly infections and injuries.
Safety is continuously reviewed by an independent data monitoring committee.
The study will continue with a long term follow up of the study population until 2017.
So far, 27,000 children, adolescents and adults have been vaccinated with three doses of the candidate dengue vaccine throughout the clinical studies.
For comments and feedback: contact email@example.com