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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01405885 | A Study of DNA Vaccine With Electroporation for the Prevention of Disease Caused by H1 and H5 Influenza Virus | PHASE1 | COMPLETED | 116 | — | — | May 1, 2011 | Aug 1, 2013 | Mar 3, 2014 | 3 | United States |
Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events
| Arm | Type | Description |
|---|---|---|
| Arm A - 0.9mg of INO-3605 | EXPERIMENTAL | - |
| Arm B - 0.9mg of INO-3609 | EXPERIMENTAL | - |
| Arm C- 0.9mg of INO-3401 | EXPERIMENTAL | - |
| Arm D- 0.3mg of INO-3609 | EXPERIMENTAL | - |
| Arm E - 0.45mg each INO-3605 , INO-3609 | EXPERIMENTAL | - |
| Arm F - 0.3mg each of INO-3401,INO-3605,INO-3609 | EXPERIMENTAL | - |
| Arm G - 0.9mg of INO-3609 | EXPERIMENTAL | - |
| Arm H - 0.9mg of INO-3609 | EXPERIMENTAL | - |
| Arm I - Seasonal influenza vaccine | ACTIVE_COMPARATOR | - |
| Arm J - 1.8mg of INO-3609 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| INO-3605 | BIOLOGICAL | 0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24. |
| INO-3609 | BIOLOGICAL | 0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24. |
| INO-3401 | BIOLOGICAL | 0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24. |
| INO-3605 AND INO-3609 | BIOLOGICAL | 0.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24. |
| INO-3510 | BIOLOGICAL | 0.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24. |
| Seasonal Influenza vaccine | BIOLOGICAL | 0.5ml of vaccine delivered IM |
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI); * Adults of either gender 18-55 years of age at entry; * Healthy subjects as judged by the ...