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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00755703 | Safety and Immunogenicity Study of Adenovirus-vectored, Intranasal Pandemic Influenza Vaccine. | PHASE1 | COMPLETED | 48 | — | — | Oct 1, 2008 | Dec 1, 2011 | May 29, 2025 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | There will be 12 subjects in Group 1 that will receive 10e8 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Group 2 | EXPERIMENTAL | There will be 12 subjects in Group 2 that will receive 10e9 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Group 3 | EXPERIMENTAL | There will be 12 subjects in Group 3 that will receive 10e10 viral particles of the Pandemic Influenza Vaccine administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Experimental: Group 4 | PLACEBO_COMPARATOR | There will be 12 subjects in Group 4 that will receive a placebo consisting of buffer administered via intranasal spray on day 0 and day 28 (+/- 4d). |
| Name | Type | Description |
|---|---|---|
| Pandemic Influenza Vaccine | BIOLOGICAL | Undetermined |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: * Healthy males and females in good general health, 19-49 years of age * Subjects must provide written consent * Willing to participate through study completion * Willing to undergo nasal washes and swabs and provide urine and blood samples per protocol for safety and immunogeni...