Approval Probability
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Adjusted LOA
ML Risk
TAK-003 · 1 trial · 1 indication
GMTs of neutralizing antibodies for each of the 4 Dengue Serotypes was measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | TDV placebo matching injection, subcutaneously (SC) once on Day 1, and Day 90. |
| TDV Lot 1 | EXPERIMENTAL | Participants were administered TDV lot 1, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| TDV Lot 2 | EXPERIMENTAL | Participants were administered TDV lot 2, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection, once on Day 1, and Day 90. |
| TDV Lot 3 | EXPERIMENTAL | Participants were administered TDV lot 3, 0.5 ml (each TDV 0.5 mL dose contained TDV-1, TDV-2, TDV-3, and TDV-4), SC injection once on Day 1, and Day 90. |
| Name | Type | Description |
|---|---|---|
| TAK-003 | BIOLOGICAL | TDV subcutaneous injection |
| Placebo | BIOLOGICAL | TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection |
Inclusion Criteria: 1. Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator. 2. Signs and dates a written informed consent form and any required privacy authorization prior ...
TAK-003 is an investigational vaccine being developed for the prevention of Dengue Fever. It is a tetravalent dengue vaccine (TDV) designed to protect against the disease. As of the available data, it has completed a Phase 3 clinical trial and remains in clinical development, not yet approved.
TAK-003 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy for Dengue Fever prevention.
TAK-003 is in Phase 3 clinical development. A Phase 3 trial has been completed, but the vaccine is still investigational and has not received regulatory approval. It is being studied for the prevention of Dengue Fever.
TAK-003 has one completed Phase 3 trial, NCT03423173, titled 'Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue.' This randomized, double-blind, placebo-controlled study enrolled 923 healthy adults aged 18 years and older in the United States.
TAK-003 is not FDA approved. It is an investigational vaccine currently in clinical development for Dengue Fever. A Phase 3 trial has been completed, but regulatory approval has not been granted based on the available information.