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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01096056 | Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children | PHASE1 | COMPLETED | 40 | — | — | Apr 5, 2010 | Dec 13, 2010 | Sep 24, 2018 | 1 | Spain |
Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).
| Arm | Type | Description |
|---|---|---|
| Influenza vaccine GSK2186877A formulation 1 Group | EXPERIMENTAL | Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6. |
| Influenza vaccine GSK2186877A formulation 2 Group | EXPERIMENTAL | Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6. |
| Name | Type | Description |
|---|---|---|
| Influenza vaccine GSK2186877A formulation 1 | BIOLOGICAL | Intramuscular administration, 2 doses |
| Influenza vaccine GSK2186877A formulation 2 | BIOLOGICAL | Intramuscular administration, 1 dose |
| Fluarix | BIOLOGICAL | Intramuscular administration, 1 dose |
Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * Children, male or female between, and includ...