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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01072799 | Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine | PHASE2 | COMPLETED | 4,560 | — | — | Oct 1, 2009 | Mar 1, 2012 | Apr 25, 2012 | 1 | Mexico |
| Arm | Type | Description |
|---|---|---|
| Low dose H1N1 | EXPERIMENTAL | - |
| Mid dose H1N1 | EXPERIMENTAL | - |
| High dose H1N1 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Two doses (Day 1 and Day 22); 0.5mL |
| A/H1N1 2009 Influenza VLP Vaccine | BIOLOGICAL | Two doses (Day 1 \& Day 22); 0.5mL |
Inclusion Criteria: 1. Male or female 18-64 years of age at the time of the vaccination. 2. Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures descr...