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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00382187 | Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in Adults | PHASE2 | COMPLETED | 40 | — | — | Nov 1, 2006 | Jan 1, 2008 | Dec 1, 2016 | 1 | Italy |
| Arm | Type | Description |
|---|---|---|
| MF59 adjuvant H5N1 influenza vaccine 7.5 micrograms | EXPERIMENTAL | - |
| MF59 adjuvant H5N1 influenza vaccine 15 micrograms | EXPERIMENTAL | - |
| non-adjuvanted influenza vaccine 15 micrograms of H5N1 antigen | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| MF59 adjuvanted H5N1 influenza vaccine | BIOLOGICAL | * MF59 adjuvanted (H5N1) influenza vaccine (Vietnam strain) containing 7.5 mg or 15 mg of H5N1 * non-adjuvanted influenza vaccine containing 15 ug of H5N1 |
Inclusion Criteria: * Male and female volunteers 18-60 years of age Exclusion Criteria: * Any auto-immune disease or other serious acute, chronic or progressive disease * Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other compo...