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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00466245 | Phase 2 Study of Safety, Tolerability, and Immunogenicity of Three Dose Levels of ACAM3000 Smallpox Vaccine | PHASE2 | COMPLETED | 590 | — | — | Jul 1, 2005 | Jun 1, 2006 | Jan 22, 2014 | - | — |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Previously vaccinated for smallpox, 1x10-8 dose |
| B | EXPERIMENTAL | Smallpox vaccine naive, 1x10-8 dose |
| C | EXPERIMENTAL | Previous smallpox vaccination, 1x10-7 dose |
| D | EXPERIMENTAL | Smallpox vaccine naive, 1x10-7 dose |
| E | EXPERIMENTAL | Previous smallpox vaccination, 1x10-6 dose |
| F | EXPERIMENTAL | Smallpox vaccine naive, 1x10-6 dose |
| G | EXPERIMENTAL | Previous smallpox vaccination, placebo dose |
| H | EXPERIMENTAL | Smallpox vaccine naive, placebo dose |
| Name | Type | Description |
|---|---|---|
| MVA Smallpox vaccine | DRUG | Two 0.5mL subcutaneous injections, separated by 28 days |
| Placebo | DRUG | Two 0.5mL subcutaneous injections, separated by 28 days |
Inclusion Criteria: * subjects must be in good general health, checked on toxicity grading table. * for previously vaccinated subjects- must be between the ages of 33 and 55 with a previous vaccine more than 10 years ago. * for vaccine naive subjects- must be between the ages of 18 and 32, and have...