Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02193087 | Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) | PHASE2 | COMPLETED | 1,002 | — | — | Aug 6, 2014 | May 19, 2015 | Jul 18, 2019 | 7 | United States |
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 ...