Japan-based Takeda Pharmaceutical has met its primary endpoint in a pivotal phase three efficacy trial for tetravalent dengue vaccine (TAK-003), it was reported yesterday.
Analysis indicated that the product effectively prevented dengue fever caused by any of the four serotypes of the virus.
According to the company, the study trial is continuing and additional results are expected at the end of this year along with results from other phase 3 studies. The firm has enrolled more than 20,000 healthy children and adolescents aged between four and 16 years living in dengue-endemic areas in the double-blind, randomized and placebo-controlled phase three study.
The firm has designed the study to evaluate the efficacy, safety and immunogenicity of two doses of the product in both dengue exposed and naive individuals. The product is not yet approved anywhere in the world.
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