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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07013487 | A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1) | PHASE3 | RECRUITING | 12,000 | — | — | Jun 11, 2025 | Oct 24, 2031 | May 12, 2026 | 40 | Indonesia, Malaysia +5 |
A MAAE is an adverse event (AE) in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an ER visit, office visit, or an urgent care visit with any medical personnel for any reason.
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.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited injection-site AEs will include pain/tenderness, erythema/redness, and swelling.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. Solicited systemic AEs will include rash, headache, tiredness (fatigue), muscle aches all over body (myalgia), joint pain and fever (pyrexia).
Fever is defined as presence of body temperature ≥ 100.4 °F. Dengue status will be confirmed by wild type (WT) reverse transcription polymerase chain reaction (RT-PCR) or non-structural protein 1 (NS1) enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| V181 | EXPERIMENTAL | Participants will receive a single 0.5 mL subcutaneous (SC) dose of V181 on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single 0.5 mL SC dose of placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| V181 | BIOLOGICAL | Participants will receive a single 0.5 mL SC dose of V181 on Day 1. |
| Placebo | BIOLOGICAL | Participants will receive a single 0.5 mL SC dose of placebo on Day 1. |
The key Inclusion Criteria include but are not limited to: * Is generally healthy based on medical history and physical examination. The key Exclusion Criteria include but are not limited to: * Has a known or suspected impairment of immunological function. * Has a history of congenital or acquire...