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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00545701 | Immunogenicity and Safety of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Adults | PHASE2 | COMPLETED | 100 | — | — | Oct 1, 2007 | Sep 1, 2008 | Jan 14, 2014 | 2 | Australia |
| NCT00415129 | Safety and Immunogenicity of an Intramuscular Pandemic Influenza Vaccine in Adults and the Elderly | PHASE2 | COMPLETED | 600 | — | — | Jun 1, 2006 | Mar 1, 2009 | Jan 14, 2014 | 4 | Belgium, United Kingdom |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Study Group 1 | EXPERIMENTAL | Vaccine with adjuvant |
| Study Group 2 | EXPERIMENTAL | Vaccine without adjuvant |
| Name | Type | Description |
|---|---|---|
| A/H5N1 inactivated, split-virion influenza virus | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 18 to 60 years on day of inclusion. * Informed Consent Form signed. * Able to attend all scheduled visits and to comply with all trial procedures. * For a woman, inability to bear a child or negative urine pregnancy test. * For a woman of child-bearing potential, use of a...