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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07047521 | A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults | PHASE3 | ACTIVE NOT_RECRUITING | 496 | — | — | Nov 7, 2025 | Jul 30, 2027 | Feb 12, 2026 | 5 | Australia |
| NCT03771963 | Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults | PHASE3 | COMPLETED | 200 | — | — | Mar 28, 2019 | Mar 13, 2020 | Jun 7, 2021 | 2 | United States |
GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 120 in the TDV (new) and TDV (current) groups will be reported.
GMTs of neutralizing antibodies for each of the 4 dengue serotypes were measured by microneutralization test 50% \[MNT50\]. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3, and DENV-4.
| Arm | Type | Description |
|---|---|---|
| Tetravalent Dengue Vaccine (TDV) (New) | EXPERIMENTAL | Participants will receive TDV (new formulation) dose 1, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose). |
| Tetravalent Dengue Vaccine (TDV) (current) | EXPERIMENTAL | Participants will receive TDV (current approved formulation) 0.5 mL dose, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose). |
| Tetravalent Dengue Vaccine (TDV) | EXPERIMENTAL | TDV 0.5 mL, injection, subcutaneously (SC), once on Day 1 (first dose) and Day 90 (second dose). |
| Name | Type | Description |
|---|---|---|
| Tetravalent Dengue Vaccine (TDV) | BIOLOGICAL | TDV subcutaneous injection |
Inclusion Criteria * Participant eligibility is determined according to the following criteria: * Participant is aged 18 to 60 years at the time of entry into the trial. * Participant is male or female. * Participant is in good health at the time of entry into the trial, as determined by medical hi...