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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01587131 | DNA-based Influenza Vaccine in the Elderly | PHASE1 | COMPLETED | 50 | — | — | Jun 1, 2012 | Mar 1, 2015 | Apr 17, 2015 | 1 | Canada |
Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events
| Arm | Type | Description |
|---|---|---|
| Group 1- DNA prime DNA boost | EXPERIMENTAL | 0.9 mg of FVH1 vaccine delivered ID followed by electroporation on Day 0, Week 15 and Week 27 |
| Group 2 - DNA prime Seasonal Vaccine boost | EXPERIMENTAL | 0.9 mg FVH1 vaccine delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15 |
| Group 3 - sWFI prime Seasonal Vaccine boost | PLACEBO_COMPARATOR | 100 microliters of sterile water for injection delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15 |
| Name | Type | Description |
|---|---|---|
| FVH1 - a DNA-based influenza vaccine | BIOLOGICAL | 0.9 mg FVH1 vaccine |
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines; * Adults of either gender ≥ 65 years of age at entry; * Healthy subjects, as judged by the Qualified Investigator based on medical history, physical examination, and normal results of an electrocardiogram (E...