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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00537524 | Immunogenicity, Safety and Tolerability of Two Doses of a Pre-pandemic Influenza Vaccine in Participants Aged 6 Months to 17 Years | PHASE2 | COMPLETED | 471 | — | — | Sep 1, 2007 | May 1, 2008 | Feb 16, 2012 | 1 | Finland |
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 0.5mL of H5N1 vaccine 7.5ug |
| Arm 2 | ACTIVE_COMPARATOR | 0.25 or 0.5mL of H5N1 vaccine |
| Name | Type | Description |
|---|---|---|
| H5N1 Influenza Vaccine | BIOLOGICAL | Two 0.5mL injections of H5N1 influenza vaccine containing 7.5μg of H5N1 antigen (A/Vietnam/1194/2004), administered 3 weeks apart, and one 0.5mL injection of H5N1 vaccine 12 months after the second dose, IM into the deltoid muscle (preferably of the non-dominant arm) or anterolateral thigh (depending on the muscle mass). |
Inclusion Criteria: * Healthy subjects Exclusion Criteria: * Receipt of Seasonal Influenza Vaccine for season 2007/2008 * Receipt of another vaccine within 3 weeks before and after each vaccination * Previous vaccination with a pandemic candidate vaccine and/or vaccine containing the adjuvant MF5...