Takeda completes enrolment for new dengue vaccine trial

Takeda has announced the completion of enrolment for TIDES, a phase III trial assessing its promising new vaccine candidate for dengue virus.

A total of 20,100 children and adolescents aged 4 to 16 have been enrolled for the double-blind, randomised and placebo-controlled study, which is designed to evaluate the efficacy, safety and immunogenicity of the live-attenuated tetravalent vaccine TAK-003.

The study is taking place in eight dengue-endemic countries: Brazil, Colombia, Panama, Dominican Republic, Nicaragua, the Philippines, Thailand and Sri Lanka, where the disease is a leading cause of serious illness among children.

In earlier phase I and II studies, the vaccine candidate was shown to induce neutralising antibody responses against all four dengue virus serotypes in both seropositive and seronegative individuals across all age groups, with no observed safety concerns.

Dr Rajeev Venkayya, president of the global vaccine business unit at Takeda, said: "This enrolment milestone demonstrates our commitment to a thorough evaluation of the safety and efficacy of our vaccine candidates and, subject to licensure, ensuring that they are available to all populations at risk."

TIDES marks the largest vaccine clinical trial conducted by Takeda to date, and was initiated in September 2016. It has completed enrolment in less than seven months, and initial results are expected in 2018.

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