Drugs / DENGUE VIRUS, LIVE ATTENUATED
DENGUE VIRUS, LIVE ATTENUATED
also known as
TAK-003 · Qdenga · Tetravalent Dengue Vaccine (TDV) · Dengue Tetravalent Vaccine (TDV) · DENVax
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Qdenga | — | 2022-12-05 | europa.eu ↗ |
Trials 9 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT06837116 | Apr → Aug 2025 | dengue disease | Prince of Songkla University | Completed | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT01110551 | May 2010 → Apr 2012 | dengue disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT07047521 | Nov 2025 → Jun 2026 overdue | dengue disease | Takeda | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04313244 | May 2021 → Feb 2022 | dengue disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03999996 | Nov 2019 → May 2024 | dengue disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03771963 | Mar → Oct 2019 | dengue disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03423173 | Feb → Aug 2018 | dengue disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT03341637 | Dec 2017 → Jan 2019 | dengue disease | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT02747927 | Apr 2016 → Jul 2018 | — | Takeda | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-12-08 | Takeda | Takeda’s QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) Approved for Use in European Union takeda.com ↗ |
| 2022-11-22 | Takeda | Takeda’s Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.S. Food and Drug Administration takeda.com ↗ |
| 2022-08-22 | Takeda | Takeda’s QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) Approved in Indonesia for Use Regardless of Prior Dengue Exposure takeda.com ↗ |
| 2016-09-07 | Takeda | Takeda Initiates Global Phase 3 Clinical Trial (TIDES) of Dengue Vaccine Candidate (TAK-003) takeda.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DENGUE VIRUS, LIVE ATTENUATED | ChEMBL registry synonym — accepted as the source's own label CHEMBL6068376 ↗ |
| Known as | Dengue Tetravalent Vaccine (TDV) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04313244 ↗ |
| Known as | DENVax | “DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera...” NCT01110551 ↗ |
| Known as | Qdenga | “Clinical trials have shown TAK-003 (Qdenga®), a live attenuated dengue tetravalent vaccine, to be well-tolerated, immunogenic, and efficacious in adults with no prior exposure...” PMID 37846724 ↗ Oct 20231“Immunogenicity of an Intradermal Qdenga Vaccine Among Healthy Volunteers” NCT06837116 ↗ |
| Known as | TAK-003 | “Clinical trials have shown TAK-003 (Qdenga®), a live attenuated dengue tetravalent vaccine, to be well-tolerated, immunogenic, and efficacious in adults with no prior exposure...” PMID 37846724 ↗ Oct 20233“The tetravalent dengue vaccine TAK-003 is contraindicated during pregnancy.” PMID 40099800 ↗ Mar 2025 “the tetravalent dengue vaccine TAK-003” PMID 40099800 ↗ Mar 2025 |
| Known as | Tetravalent Dengue Vaccine (TDV) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02747927 ↗ |
| Modality | Vaccine | “live attenuated dengue vaccine” NCT01110551 ↗ |
| Route | Subcutaneous | “DENVax administered subcutaneously.” NCT01110551 ↗ |