Sanofi's dengue vaccine meets main goal of late-stage study

Sanofi announced Monday that the first of two pivotal Phase III trials of its investigational dengue vaccine achieved the primary endpoint of significantly reducing the incidence of the disease. The company added that initial safety data are also consistent with the "good safety profile" seen in earlier studies, with principal investigator Rose Capeding noting "this is the first time ever a dengue vaccine successfully completed" late-stage testing.

The study included 10 275 children aged 2 to 14 years who were enrolled from dengue-endemic areas of Indonesia, Malaysia, the Philippines, Thailand and Vietnam from 2011 to 2013. Participants were randomly assigned either three injections of Sanofi's dengue vaccine candidate or placebo at six-month intervals.

Results showed that the vaccine cut the number of symptomatic virologically-confirmed cases of dengue from any serotype by 56 percent. The drugmaker noted that at 4.7 percent, the annual rate of dengue incidence observed in the control group "demonstrates the very high burden of disease in Asia," however it did not provide similar data for the vaccinated group. Sanofi said the study will continue with a long-term follow-up of the population.

The company indicated it will fully analyse the results in the weeks ahead, with data to be presented at an upcoming medical conference and also published later this year in a peer-reviewed journal. Meanwhile, Sanofi said data from a second efficacy trial involving more than 20 000 participants in Latin America, including from Brazil, Colombia, Honduras, Mexico and Puerto Rico, are anticipated in the third quarter.

The latest findings follow mixed results reported by Sanofi in 2012, when the company said its dengue vaccine was only about 30 percent effective in a mid-stage study of 4002 children aged 4 to 11 in Thailand. At the time, the drugmaker noted that the vaccine appeared partially effective against three of the four dengue strains, but failed to protect against serotype 2, which was widespread in the region when the trial was conducted.

Last year, Sanofi reported 3.7 billion euros ($5.1 billion) in vaccine sales.

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