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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00850616 | Three-Dose Regimen of MRKAd5+6 Trigene (V526) in Healthy Adults (V526-001)(COMPLETED) | PHASE1 | COMPLETED | 147 | — | — | Apr 1, 2005 | Mar 1, 2011 | Nov 2, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | MRKAd6 Trigene 0.5x10\^9 Ad6 vg |
| 2 | EXPERIMENTAL | MRKAd6 Trigene 0.5x10\^10 Ad6 vg |
| 3 | EXPERIMENTAL | MRKAd6 Trigene 0.5x10\^11 Ad6 vg |
| 4 | EXPERIMENTAL | MRKAd5 Trigene 0.5x10\^10 Ad5 vg |
| 5 | EXPERIMENTAL | MRKAd5 Trivalent 1.5x10\^10 Ad5 vg |
| 6 | EXPERIMENTAL | MRKAd5+6 Trigene 1x10\^9 Ad vg |
| 7 | EXPERIMENTAL | MRKAd5+6 Trigene 1x10\^10 Ad vg |
| 8 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| V526 | BIOLOGICAL | 0.5 mL intramuscular injections of MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4 and Week 26. |
| Comparator: Placebo to V526 | BIOLOGICAL | 0.5 mL intramuscular injections of placebo to MRKAd5+6 trigene vaccine (V526) in a 3-dose regimen on Day 1, Week 4, and Week 26. |
Inclusion Criteria: * Subject has negative tests for HIV, Hepatitis B, and Hepatitis C within 60 days of injection * Subject agrees to use an acceptable method of birth control through week 52 of the study Exclusion Criteria: * Subject has been given immune globulin or blood products within 30 da...