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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02111070 | Immunogenicity and Safety Study of Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects | PHASE1 | COMPLETED | 44 | — | — | Sep 1, 2012 | Oct 1, 2012 | Apr 10, 2014 | 1 | South Korea |
Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia
Seroprotection: HI antibody titer ≥ 1:40 28 days after the administration of the study vaccine
| Arm | Type | Description |
|---|---|---|
| ILYANG Inactivated split influenza vaccine | EXPERIMENTAL | IL-YANG FLU Vaccine Vial INJ 0.5mL by intramuscular injection |
| Name | Type | Description |
|---|---|---|
| IL-YANG FLU Vaccine | BIOLOGICAL | 0.5mL |
Inclusion Criteria: * Healthy males between 20 and 55 years of age at screening * Body weight of ≥ 55kg and within ±20% of ideal body weight (ideal body weight = (height cm - 100) X 0.9) at screening * Subjects with no congenital or chronic disease who were considered suitable for the study after s...