Japanese-based pharmaceutical firm Takeda Pharmaceutical has concluded enrolment in Phase III tetravalent immunisation against dengue efficacy study (TIDES) trial of TAK-003 to protect against all four strains of the dengue virus.
TAK-003 is the firm's live-attenuated tetravalent dengue vaccine candidate.
The double-blind, randomised and placebo-controlled Phase III trial enrolled 20,100 children and adolescents aged four to 16.
The trial will assess the efficacy, safety and immunogenicity in eight dengue-endemic countries in Latin America and Asia, including Brazil, Colombia, Panama, Dominican Republic, Nicaragua, Philippines, Thailand and Sri Lanka.
Takeda Global Vaccine business unit president Rajeev Venkayya said: “The successful enrolment of more than 20,000 children and adolescents in this Phase III trial, across several continents, and on an ambitious timeline, while maintaining a clear focus on quality and subject safety, reflects Takeda’s prioritisation of dengue and the substantial capabilities of our global organisation."
The TIDES trial will evaluate two subcutaneous doses of TAK-003, given three months apart at Day 1 and Day 90.
The trial's primary objective is protection against virologically confirmed dengue of any severity and by any of the dengue serotypes.
The secondary endpoints will measure the efficacy of the vaccine to prevent the disease, hospitalisation and severe dengue associated with any dengue serotype.
The frequency and severity of adverse events (AEs) or serious AEs, seropositivity rate and geometric mean titers (GMTs) of neutralising antibodies in the immunogenicity subset will also be examined.
The initial results of the Phase III TIDES trial are expected to be reported next year.