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- 88.5% reduction of Dengue Haemorrhagic Fever shown in detailed analyses of world's first phase III efficacy study published in The Lancet -
- Two thirds reduction in hospitalization observed -- Favorable safety profile is consistent with safety documented in previous studies -LYON, France - July 11, 2014 - Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT:SAN) (NYSE:SNY), today 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
1. 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).
Dengue is a threat to nearly half the world's population, and is a pressing public health priority in many countries in Asia and Latin America where epidemics occur. The study confirmed the very high burden of disease by revealing that one in twenty children in the control group suffered from dengue each year, which was three-fold higher than initially expected. Each year, an estimated 500,000 people, including children, have severe dengue requiring hospitalization.
2 This puts huge strain on hospitals and health care systems during outbreaks.
2"The results of this first phase III study show the potential of the vaccine to have a significant impact on public health," commented Dr. Maria Rosario Capeding, study principal investigator, Research Institute for Tropical Medicine, the Philippines.
"The threat of severe dengue disease creates fear in the community. The vaccine's impact on preventing dengue haemorrhagic fever is noteworthy. A vaccine that is able to avoid the personal suffering and reduce this significant health burden would change the lives of millions."
Safety analyses (solicited reactions, unsolicited events and Serious Adverse Events 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. To date, 27,000 children, adolescents and adults have been vaccinated with three doses of the candidate dengue vaccine throughout the clinical studies.