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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01857206 | Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age | PHASE3 | COMPLETED | 2,055 | — | — | May 1, 2013 | Jun 1, 2014 | Dec 5, 2014 | 34 | United States, Australia +3 |
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.
| Arm | Type | Description |
|---|---|---|
| TIVc | EXPERIMENTAL | Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status. |
| TIVf | ACTIVE_COMPARATOR | Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status. |
| Name | Type | Description |
|---|---|---|
| Mammalian cell based flu vaccine | BIOLOGICAL | - |
| Egg based flu vaccine | BIOLOGICAL | - |
Inclusion Criteria: \- Healthy subjects 4-17 years of age Exclusion Criteria: * Subjects who are not healthy, * Subjects who are pregnant or breast feeding, * Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.