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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00765076 | Clinical Study of the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in People Aged 65 Years or Older | PHASE3 | COMPLETED | 192 | — | — | Oct 16, 2008 | Dec 4, 2009 | Jul 31, 2018 | 4 | United States, Spain |
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin-2 (IL-2), tumor necrosis factor alpha (TNF-α), interferon-gamma (IFN-γ)
| Arm | Type | Description |
|---|---|---|
| New generation influenza vaccine GSK2186877A Group | EXPERIMENTAL | Subjects aged ≥ 65 years receiving 1 dose of New generation influenza vaccine GSK2186877A at Day 0 |
| Fluarix elderly Group | ACTIVE_COMPARATOR | Subjects aged \>= 65 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Fluarix young Group | ACTIVE_COMPARATOR | Subjects aged 18-40 years receiving 1 dose of Fluarix vaccine at Day 0 |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' influenza vaccine GSK2186877A | BIOLOGICAL | One intramuscular injection at Day 0 |
| GSK Biologicals' Fluarix | BIOLOGICAL | One intramuscular injection at Day 0 |
Inclusion Criteria: All subjects must satisfy the following criteria at study entry: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subje...