Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TDV Liquid Formulation 1 · 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 Formulation 1 is an investigational small molecule being developed for the prevention of dengue fever. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety and immunogenicity.
TDV Liquid Formulation 1 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this dengue vaccine candidate.
TDV Liquid Formulation 1 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under investigation for the prevention of dengue fever.
TDV Liquid Formulation 1 has been studied in one completed Phase 2 clinical trial with the identifier NCT02193087. This randomized, double-blind, active-controlled study enrolled 1,002 healthy adult volunteers in the United States to evaluate the safety and immunogenicity of three formulations of Takeda's tetravalent dengue vaccine candidate.
Yes, TDV Liquid Formulation 1 is one of the formulations evaluated in the clinical trial titled 'Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)'. It is part of Takeda's tetravalent dengue vaccine candidate program, which aims to protect against all four dengue virus serotypes.