Sanofi Pasteur Posts Phase 3 Trial Results For Dengue Vaccine
Sanofi Pasteur announced the results of the company’s first landmark Phase 3 trial of its investigational dengue vaccine.
Results from the Phase 3 clinical trial for the dengue vaccine candidate show that the vaccine met the primary objective of safety and efficacy after three vaccinations were given to prevent symptomatic virologically-confirmed dengue cases. More than 31,000 children from dengue endemic areas in Asia and Latin America were randomized to receive either three injections of the dengue vaccine or placebo. Sanofi Pasteur published positive Phase 3 results from the Latin America arm of the trial earlier this year.
New trial findings demonstrate the vaccine’s overall efficacy against symptomatic dengue disease, with a 60.8 percent efficacy rating in patients aged 9 to 16 years old. The vaccine achieved 95.5 percent protection against severe dengue and reduced the risk of hospitalization by 80.3 percent during the trial. The company published the results of the Phase 3 trial in The New England Journal of Medicine.
Dr. Roberto Tapia-Conyer, Director General Carlos Slim Foundation in Mexico, said that the economic and social costs of a dengue outbreak can strain healthcare systems. “Broad public immunization programs will be critical in achieving the full benefit of a dengue vaccine within a public health perspective, to reach the control of the disease.”
“Until now, we were only able to provide supportive care for patients with dengue. On the strength of the outcome of this phase 3 efficacy study, we hope this will become an effective preventive measure against dengue. I will welcome a dengue vaccine that can prevent the personal suffering of severe disease and hospitalization,” said Dr. Rivaldo Cunha, Infectious Disease Specialist, and a primary investigator in the study.
The company expects to file for registration of its dengue vaccine in a number of dengue-endemic countries in 2015. Sanofi Pasteur said that it is already producing the vaccine at its new dedicated facility in Neuville-sur-Saône, France capable of large-scale production to meet global demand.