AsianScientist (Apr. 29, 2014) – Sanofi Pasteur, the vaccines division of Sanofi, announced that the first of two pivotal Phase III efficacy studies with its dengue vaccine candidate has achieved its primary clinical endpoint.
The efficacy study showed a significant reduction of 56 percent of dengue disease cases. Initial safety data are consistent with the good safety profile observed in previous studies.
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 annual incidence rate of 4.7 percent observed in the control group demonstrates the very high burden of disease in Asia.
The results of this first, large-scale efficacy study will be further complemented by results in Q3 2014 from a second, large-scale study currently conducted in Latin America, including more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico.
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 and were randomized to either receive three injections of the dengue vaccine or a placebo at six-month intervals. The primary endpoint was measured by the number of symptomatic virologically-confirmed dengue cases caused by any serotype.
“This achievement is the result of more than 20 years of work in the field of dengue, collaborating with investigators, volunteers, authorities, scientific experts and international organizations,” said Olivier Charmeil, President and CEO of Sanofi Pasteur. “Our goal is to make dengue the next vaccine-preventable disease and to support the WHO’s ambition to reduce dengue mortality by 50 percent and morbidity by 25 percent by 2020.”
Source: Sanofi Pasteur; Photo: javierdevilman/Flickr/CC.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.