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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03423173 | Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue | PHASE3 | COMPLETED | 923 | — | — | Feb 12, 2018 | Jan 14, 2019 | Oct 20, 2020 | 14 | United States |
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 ...