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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02307851 | Quadrivalent Influenza VLP Vaccine Dose Ranging Study in Young Adults | PHASE2 | COMPLETED | 400 | — | — | Nov 1, 2014 | Jun 1, 2015 | Sep 23, 2016 | 5 | United States |
Derived/calculated endpoints based on: Seroconversion rate (SCR) Seroprotection rate (SPR) Geometric mean titer (GMT) Geometric mean ratio (GMR)
Number and percentage of subjects with solicited local and systemic adverse events over the seven days post-injections; all adverse events (including adverse changes in clinical laboratory parameters) over 21 days post-injections; and Medically Attended Events (MAEs), Serious Adverse Events (SAEs), and Significant New medical Conditions (SNMCs) through six months.
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | Quadrivalent VLP vaccine, low dose, intramuscular injection (0.5mL) |
| Group B | EXPERIMENTAL | Quadrivalent VLP vaccine, high dose, intramuscular injection (0.5mL) |
| Group C | EXPERIMENTAL | Quadrivalent VLP vaccine, medium dose, intramuscular injection (0.5mL) |
| Group D | ACTIVE_COMPARATOR | Comparator TIV, intramuscular injection (0.5mL) |
| Name | Type | Description |
|---|---|---|
| Quadrivalent VLP Vaccine | BIOLOGICAL | - |
| Comparator TIV | BIOLOGICAL | - |
Inclusion Criteria: 1. Healthy adult male or female, 18-49 years of age 2. Willing and able to give informed consent prior to study enrollment 3. Able to comply with study requirements 4. Women of child-bearing potential must have a negative urine pregnancy test at vaccination, will be advised thro...