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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01006798 | Safety and Immunogenicity of Replication-Competent Adenovirus 4-vectored Vaccine for Avian Influenza H5N1 | PHASE1 | COMPLETED | 166 | — | — | Oct 1, 2009 | Sep 1, 2011 | Mar 18, 2024 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | three vaccinations of 10\^7vp Ad4-H5-Vtn or placebo |
| Cohort 2 | EXPERIMENTAL | three vaccinations of the 10\^8vp Ad4-H5-Vtn or placebo |
| Cohort 3 | EXPERIMENTAL | three vaccinations of 10\^9 Ad4-H5-Vtn or placebo |
| Cohort 4 | EXPERIMENTAL | three vaccinations of 10\^10 Ad4-H5-Vtn or placebo |
| Cohort 5 | EXPERIMENTAL | three vaccinations of 10\^11 Ad4-H5-Vtn or placebo |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | enteric coated capsule containing no vaccine virus |
| Ad4-H5-Vtn | BIOLOGICAL | a live, replication-competent, recombinant Ad4 virus expressing the HA of H5N1 influenza (A/Vietnam/1194/2004) in an enteric capsule for oral administration |
| Sanofi Pasteur Influenza Virus Vaccine, H5N1 | BIOLOGICAL | Single administration of a heterologous boost given to volunteers 3 to 15 months following their last vaccination with Ad4-H5-Vtn or placebo. |
Inclusion Criteria: * Healthy adults and their healthy adult household contacts. Exclusion Criteria: * Healthcare workers who have direct contact with patients who are immunodeficient, are HIV-positive, have an unstable medical condition, or are under the age of 18. * Childcare workers who have d...