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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00995865 | Trial of Yellow Fever Inactivated Vaccine | PHASE1 | COMPLETED | 60 | — | — | Jan 1, 2010 | Oct 1, 2010 | May 5, 2016 | 1 | United States |
Subjects were observed for 60 minutes (greater than of equal to 60 minutes and less than of equal to 90 minutes) after vaccine adminstration for any signs or symptoms or local and/or systematic intolerance to the test articles and vital signs were to be checked within the same observation timeframe. After vaccination, subjects were to complete a memory aid to record daily temperature, symptoms, and concomitant medications from Day-0 to Day-42. Subjects were to return to the clinic on Days 3, 10, 21, 24, 31, and 42 with a second vaccination given on Day 21. At each visit, study personnel were to conduct a structured adverse event (AE) interview, and subject were to use their memory aid to assist with the recall of symptoms experiences and daily oral temperatures.
| Arm | Type | Description |
|---|---|---|
| High dose | ACTIVE_COMPARATOR | - |
| Mid Dose | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | NaCl Injectable 0.9% |
| Name | Type | Description |
|---|---|---|
| XRX-001 Inactivated yellow fever vaccine | BIOLOGICAL | Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10\^8 VE/0.5mL and Mid dose = 2.2 x 10\^7 VE/0.5mL |
| Placebo | BIOLOGICAL | NaCl Injectable 0.9% |
Inclusion Criteria: * All aspects of the protocol explained and written informed consent obtained from the subject; * Aged 18 to 49 years, inclusive; * In good general health, without significant medical history, physical examination findings, or abnormal laboratory results; and * Subject must be a...