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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05507450 | Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003) | PHASE2 | COMPLETED | 1,271 | — | — | Sep 7, 2022 | May 7, 2024 | May 9, 2025 | 32 | United States, Australia +5 |
A dengue VRNT was conducted to assess neutralizing antibody Geometric Mean Titers (GMTs) for each of the 4 dengue vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination.
An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
| Arm | Type | Description |
|---|---|---|
| V181 High-Potency Level Group | EXPERIMENTAL | Participants will receive a single 0.5mL subcutaneous (SC) dose of V181 High-Potency vaccine. |
| V181 Mid-Potency Level Group | EXPERIMENTAL | Participants will receive a single 0.5mL SC dose of V181 Mid-Potency vaccine. |
| V181 Low-Potency Level Group | EXPERIMENTAL | Participants will receive a single 0.5mL SC dose of V181 Low-Potency vaccine. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single SC 0.5 mL dose of placebo. |
| Name | Type | Description |
|---|---|---|
| V181 High-Potency Level | BIOLOGICAL | 0.5 mL SC dose of V181 High-Potency vaccine |
| V181 Mid-Potency Level | BIOLOGICAL | 0.5 mL SC dose of V181 Mid-Potency vaccine |
| V181 Low-Potency Level | BIOLOGICAL | 0.5 mL SC dose of V181 Low-Potency vaccine |
| Placebo | BIOLOGICAL | 0.5 mL SC dose of placebo |
Inclusion Criteria: * Male participants are eligible to participate if they agree to the following for at least 90 days after administration of study intervention: Abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree ...