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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01014806 | Evaluate the Safety and Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine in Older Adults | PHASE2 | COMPLETED | 467 | — | — | Nov 1, 2009 | May 1, 2010 | Jul 18, 2013 | 6 | United States |
| NCT00754455 | Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults | PHASE2 | COMPLETED | 317 | — | — | Sep 1, 2008 | Mar 1, 2009 | Jul 18, 2013 | 4 | United States |
| Arm | Type | Description |
|---|---|---|
| Low dose | EXPERIMENTAL | - |
| High dose | EXPERIMENTAL | Investigational Influenza VLP Vaccine 60ug/strain |
| TIV | ACTIVE_COMPARATOR | Trivalent Influenza Vaccine 15ug/strain, Commercially Licenced |
| Mid dose | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Influenza VLP Vaccine | BIOLOGICAL | Single dose; 0.5mL |
| TIV | BIOLOGICAL | Trivalent Influenza Vaccine 15ug/strain, commercially licensed |
| Influenza VLP Vaccine (recombinant) | BIOLOGICAL | Single injection Day 0; 0.5mL |
| Placebo | BIOLOGICAL | Placebo as a single injection of 0.5 mL. |
Inclusion Criteria: 1. Healthy male or female \> 60 years of age at the time of the vaccination. 2. Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedur...