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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00519389 | Safety, Reactogenicity and Immunogenicity of an H5N1 VLP | PHASE1 | COMPLETED | 230 | — | — | Jul 1, 2007 | Nov 1, 2008 | Jun 21, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Low dose H5N1 VLP Vaccine | EXPERIMENTAL | - |
| Mid dose H5N1 VLP Vaccine | EXPERIMENTAL | - |
| High dose H5N1 VLP Vaccine | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| H5N1 VLP Vaccine | BIOLOGICAL | Two doses - Day 0 \& Day 28 |
| Placebo | BIOLOGICAL | Two doses - Day 0 \& Day 28 |
Inclusion Criteria: 1. Male or female 18 to 40 years of age at the time of the vaccination. 2. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool). 3. Available by telephone. ...