Japan-based Takeda Pharmaceutical has revealed results from the primary endpoint analysis of the ongoing pivotal Phase three Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) that were published in the New England Journal of Medicine, it was reported on Friday.

The company's dengue vaccine candidate indicated protection against virologically-confirmed dengue, the trial primary endpoint, in children ages 4 to 16 years. Vaccine efficacy was 80.2% in the 12-month period after the second dose, which was administered three months after the first dose.

The firm's dengue vaccine candidate was generally well tolerated, and no important safety risks have been observed to date. The observed safety profile was consistent with results reported in earlier studies of TAK-003.1,2,3,4.

The TIDES trial will continue to assess safety and efficacy in study subjects for a total of four and a half years.