TAK-003 is an investigational live-attenuated tetravalent dengue vaccine, preventing dengue fever caused by any of the four serotypes of the dengue virus. Takeda's tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four vaccine viruses.
TAK-003 is indicated for the prevention of Dengue virus caused by any of the four serotypes.
TAK-003 will be given as a single DV 0.5 mL subcutaneous injection on Day 1 and Day 90 in the clinical trial.
TAK-003 is not currently licensed anywhere in the world.
January 29, 2019, Takeda announced TAK-003 which is in a pivotal Phase 3 trial met the primary efficacy endpoint.
Clinical Trial NCT02747927: Efficacy, Safety, and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES)
- This Phase III, Double-Blind, Randomized, Placebo-Controlled Trial is to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in 21,000 Healthy Children Aged 4 - 16 Years Old
- The purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity, due to any of the four dengue virus serotypes in 4 to 16-year-old participants.
- TAK-003 was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. While the review of the extensive data set is ongoing, TAK-003 was well tolerated with no significant safety concerns to date.
- The Phase 3 clinical trial is continuing and additional results are expected later this year.