Drugs / Tetravalent Dengue Vaccine Candidate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | asymptomatic dengue | 2021-05-11 | “TAK-003: Takeda’s tetravalent dengue vaccine candidate, has completed its first regulatory submissions with possible approval in the EU and some endemic countries in FY2021.” takeda.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03746015 | Dec 2018 → Mar 2021 | dengue disease | Takeda | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 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). |
| 2022-12-08 | 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. |
| 2022-11-22 | 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. |
| 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. |
| 2017-11-07 | Takeda | Results Takeda’s Dengue Vaccine Candidate Associated with Reduced Incidence of Dengue in Children and Adolescents; New 18-Month Interim Phase 2 Data Published in The Lancet Infectious Diseases takeda.com ↗
The results of this interim analysis, a pre-planned evaluation of data from an ongoing trial, show that TAK-003 is associated with a reduction in the incidence of dengue in children and adolescents. |
| 2017-03-29 | Takeda | Results Takeda’s Dengue Vaccine Candidate Elicited Broad Immune Responses in Children and Adolescents Living in Dengue-Endemic Areas; Interim Phase 2 Analysis Published in The Lancet Infectious Diseases takeda.com ↗
The published data showed that TAK-003 elicited a broad antibody response against all four dengue virus types (called serotypes), regardless of previous exposure to the dengue virus. |
All press releases naming this drug 15 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tetravalent Dengue Vaccine Candidate | “The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV).” NCT03746015 ↗ |
| Known as | TDV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03746015 ↗ |
| Route | Subcutaneous | “All participants will receive subcutaneous injection of TDV on Day 1 (Month 0) and Day 90 (Month 3).” NCT03746015 ↗ |