Drugs / DENVax
last change Nov 2025 re-read 9 days ago

DENVax

also known as TAK-003 · TDV
Developed for
dengue disease
Investigated by
Takeda

Trials 1

2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT03342898 Feb → May 2018 dengue disease Takeda Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-11-03 Takeda Results New Phase 3 Data Show Takeda’s Dengue Vaccine Delivers 7 Years of Sustained Protection Against Infection and Hospitalization takeda.com ↗
These data, including an exploratory analysis of a booster dose, confirm the favorable benefit and risk profile of QDENGA and that the two-dose regimen provides sustained protection against dengue.
2023-10-03 Takeda Regulatory Takeda’s Dengue Vaccine Recommended by World Health Organization Advisory Group for Introduction in High Dengue Burden and Transmission Areas in Children Ages Six to 16 Years takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003).
2022-11-22 Takeda Regulatory Takeda’s Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.S. Food and Drug Administration takeda.com ↗
Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, the company’s investigational dengue vaccine candidate.

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as DENVax “The vaccine tested in this study is TDV also known as TAK-003 (DENVax).” NCT03342898 ↗
Known as TAK-003 “The vaccine tested in this study is TDV also known as TAK-003 (DENVax).” NCT03342898 ↗
Known as TDV ClinicalTrials.gov intervention name — accepted as the source's own label NCT03342898 ↗
Route Subcutaneous “TDV, 0.5 mL, injection, SC” NCT03342898 ↗