Drugs / DENVax
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01765426 | Feb 2013 → Jun 2014 | — | Takeda | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2022-12-08 | Takeda | Regulatory Takeda’s QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) Approved for Use in European Union takeda.com ↗
The European Commission's approval marks an important turning point for QDENGA as we are one step closer to achieving our aspiration to help reduce the global burden of dengue. |
| 2022-10-14 | Takeda | Regulatory Takeda Receives Positive CHMP Opinion Recommending Approval of Dengue Vaccine Candidate in EU and Dengue-Endemic Countries takeda.com ↗
The final step in the path to approval in Europe is Marketing Authorization from the EMA, which is expected in the coming months. |
| 2022-08-22 | Takeda | Regulatory Takeda’s QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) Approved in Indonesia for Use Regardless of Prior Dengue Exposure takeda.com ↗
QDENGA is the only dengue vaccine approved in Indonesia for use in individuals regardless of previous dengue exposure and without the need for pre-vaccination testing. |
| 2022-06-09 | Takeda | Results Takeda’s Dengue Vaccine Candidate Provides Continued Protection Against Dengue Fever Through 4.5 Years in Pivotal Clinical Trial takeda.com ↗
Through four and a half years, TAK-003 demonstrated 84.1% vaccine efficacy (VE) (95% CI: 77.8, 88.6) against hospitalized dengue, with 85.9% VE (78.7, 90.7) in seropositive individuals and 79.3% VE (63.5, 88.2) in seronegative individuals. |
| 2021-05-22 | Takeda | Results Potential Impact of Takeda’s Dengue Vaccine Candidate Reinforced by Long-Term Safety and Efficacy Results takeda.com ↗ |
| 2021-03-25 | Takeda | Regulatory Takeda Begins Regulatory Submissions for Dengue Vaccine Candidate in EU and Dengue-Endemic Countries takeda.com ↗
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that the European Medicines Agency (EMA) has accepted the Company’s filing packages for its dengue vaccine candidate (TAK-003) |
| 2020-03-17 | Takeda | Results The Lancet publishes papers from two studies of Takeda’s dengue vaccine candidate takeda.com ↗
In the second paper, final 48-month results from a Phase 2 trial described long-term safety and demonstrated the durability of immune responses to Takeda’s dengue vaccine candidate. |
| 2019-11-23 | Takeda | Results Takeda Presents 18-Month Data from Pivotal Phase 3 Trial of Dengue Vaccine Candidate at the American Society of Tropical Medicine and Hygiene (ASTMH) 68 th Annual Meeting takeda.com ↗
The TIDES trial met all secondary endpoints for which there were a sufficient number of cases. |
| 2019-11-06 | Takeda | Results Takeda’s Dengue Vaccine Candidate Demonstrates Protection in Children Ages Four to 16 Years, Regardless of Previous Dengue Exposure takeda.com ↗
Takeda’s dengue vaccine candidate demonstrated protection against virologically-confirmed dengue (VCD), the trial primary endpoint, in children ages four to 16 years. |
| 2019-01-29 | Takeda | Results Takeda’s Dengue Vaccine Candidate Meets Primary Endpoint in Pivotal Phase 3 Efficacy Trial takeda.com ↗
This first analysis of the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial showed that the company’s investigational live-attenuated tetravalent dengue vaccine (TAK-003) was efficacious in preventing dengue fever caused by any of the four serotypes of the virus. |
All press releases naming this drug 10 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DENVax | “Takeda's Tetravalent Dengue Vaccine Candidate (TDV) \[previously DENVax\]” NCT01765426 ↗ |
| Known as | TDV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01765426 ↗ |
| Modality | Vaccine | “tetravalent dengue vaccine candidate” NCT01765426 ↗ |
| Route | Other | “administered intradermally” NCT01765426 ↗ |