Takeda initiates TIDES study of TAK 003 vaccine to treat Dengue fever.

Takeda Pharmaceutical Company Limited announced that it has vaccinated the first subject in the Tetravalent Immunization against Dengue Efficacy Study (TIDES) study , a Phase III double-blind, randomized and placebo-controlled trial of its live-attenuated tetravalent dengue vaccine candidate (TAK-003).

TIDES will enroll approximately 20,000 healthy children between the ages of four and 16 years living in dengue-endemic countries in Latin America and Asia. The study will evaluate the efficacy of the vaccine candidate to protect subjects against symptomatic dengue fever caused by any of the four dengue virus serotypes, regardless of age and whether the individual has previously been exposed to the virus. The study will also evaluate vaccine safety and immunogenicity, and will involve two doses of the vaccine candidate or placebo administered 90 days apart.

TIDES will build on previous studies which have assessed the tolerability, safety and immunogenicity of the vaccine against all four dengue serotypes in multiple age groups to determine whether the vaccine helps prevent symptomatic dengue.