Tetravalent dengue vaccine: Phase III data

A double-blind, Latin American Phase III trial in 20,875 healthy children and adolescents ages 9-16 showed that 0.5 mL subcutaneous injections of Sanofi's tetravalent dengue vaccine given at 0, 6 and 12 months met the primary endpoint of reducing the number of symptomatic virologically confirmed dengue cases caused by any serotype occurring >28 days after the third dose vs. placebo. The vaccine reduced the number of dengue cases by 60.8% vs. placebo. Vaccine efficacy rates for each of the dengue virus serotypes were 50.3% against serotype 1, 42.3% against serotype 2, 74% against serotype 3 and 77.7% against serotype 4. Additionally, the vaccine led to an 80.3% reduction in the risk of hospitalization due to dengue. Additional data will be presented at the American Society of Tropical Medicine and Hygiene meeting in New Orleans in November.

Earlier this year, Sanofi reported data from an Asian Phase III trial in 10,275 healthy children ages 2-14 showing that the vaccine met the primary endpoint of reducing the number of symptomatic virologically confirmed dengue cases caused by any serotype vs. placebo (see BioCentury, May 5 & Aug. 4). ...