Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals 2-dose inactivated hepatitis A vaccine · 1 trial · 1 indication
Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
| Arm | Type | Description |
|---|---|---|
| Havrix Group | ACTIVE_COMPARATOR | Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9. |
| Havrix+Prevnar Group | EXPERIMENTAL | Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9. |
| Prevnar Havrix Group | ACTIVE_COMPARATOR | Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) | BIOLOGICAL | Two doses, administered intramuscularly in the right anterolateral thigh. |
| Prevnar™ | BIOLOGICAL | One dose, administered intramuscularly in the left anterolateral thigh. |
Inclusion Criteria: * A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase, * Free of obvious health problems, * Subjects must have previously received three doses of Prevnar in his/her first year of life. Exclusion Criteria: * Use of any investigational or...