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Also known as TDV Liquid Formulation 1
TDV Liquid · 1 trial · 1 indication
Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.
| Arm | Type | Description |
|---|---|---|
| Group A: TDV Liquid + Placebo | ACTIVE_COMPARATOR | Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3). |
| Group B: TDV Liquid | ACTIVE_COMPARATOR | TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3). |
| Group C: TDV Liquid | EXPERIMENTAL | TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3). |
| Group D: TDV Lyophilized | EXPERIMENTAL | TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3). |
| Name | Type | Description |
|---|---|---|
| TDV Liquid Formulation 1 | DRUG | TDV Liquid Formulation 1 for subcutaneous injection |
| TDV Liquid Formulation 2 | DRUG | TDV Liquid Formulation 2 for subcutaneous injection |
| TDV IDT Lyophilized | DRUG | TDV Lyophilized Formulation for subcutaneous injection |
| Placebo | DRUG | TDV liquid formulation placebo-matching solution for subcutaneous injection |
Inclusion Criteria: 1. Is aged 18 to 49 years, at the time of enrollment inclusive. 2. Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator. 3. Signs and dates ...
TDV Liquid is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for the prevention of dengue fever. It is a liquid formulation of Takeda's tetravalent dengue vaccine candidate, studied in a Phase 2 clinical trial. It is also known as TDV Liquid Formulation 1.
TDV Liquid is being developed for dengue fever, an infectious disease. It is a vaccine candidate intended to be given to healthy adult volunteers. The Phase 2 study enrolled participants 18 years of age and older in the United States.
TDV Liquid is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating this liquid formulation of its tetravalent dengue vaccine candidate.
TDV Liquid is in Phase 2 development. It is investigational and has not been approved by the FDA. The Phase 2 trial evaluating three formulations of Takeda's tetravalent dengue vaccine candidate has been completed, and no trials of TDV Liquid are currently active.
TDV Liquid was evaluated in the Phase 2 trial NCT02193087, titled Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The completed study enrolled 1,002 participants in the United States, was randomized, double blind, and used an active control.
Yes, TDV Liquid is also known as TDV Liquid Formulation 1. Both names refer to the same liquid formulation of Takeda's tetravalent dengue vaccine candidate that was evaluated in the Phase 2 trial NCT02193087 for dengue fever.