Drugs / Takeda's Tetravalent Dengue Vaccine Candidate
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT01542632 | Feb 2012 → Jan 2014 | — | Takeda | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 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. |
| 2022-06-09 | 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. |
All press releases naming this drug 9 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 | Takeda's Tetravalent Dengue Vaccine Candidate | “Takeda's Tetravalent Dengue Vaccine Candidate (TDV)” NCT01542632 ↗ |
| Known as | TDV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01542632 ↗ |
| Modality | Vaccine | “Tetravalent Chimeric Dengue Vaccine” NCT01542632 ↗ |
| Route | Subcutaneous | “TDV subcutaneous injection” NCT01542632 ↗ |