Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' Influenza investigational vaccine GSK2340274A · 1 trial · 1 indication
Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre
A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
| Arm | Type | Description |
|---|---|---|
| AREPANRIX-ADJUVANTED F1 2D GROUP | EXPERIMENTAL | Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| AREPANRIX-ADJUVANTED F2 2D GROUP | EXPERIMENTAL | Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| AREPANRIX-ADJUVANTED F2 3D GROUP | EXPERIMENTAL | Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster). |
| AREPANRIX-UNADJUVANTED F2 2D GROUP | EXPERIMENTAL | Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' Influenza investigational vaccine GSK2340274A | BIOLOGICAL | One or two doses administered intramuscularly |
| GSK Biologicals' Influenza investigational vaccine GSK2340273A | BIOLOGICAL | Two doses intramuscularly |
| Placebo (saline) | BIOLOGICAL | One dose intramuscularly |
Inclusion Criteria: * Male or female children 10 to \< 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol. * Written informed c...