Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biological's investigational MMRV vaccine 208136 · 1 trial · 4 indications
Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
| Arm | Type | Description |
|---|---|---|
| Priorix-Tetra Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. |
| Priorix/ Priorix-Tetra Group | EXPERIMENTAL | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh. |
| Control Group | ACTIVE_COMPARATOR | Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. |
| Name | Type | Description |
|---|---|---|
| GSK Biological's investigational MMRV vaccine 208136 | BIOLOGICAL | Subcutaneous injection |
| Priorix™ | BIOLOGICAL | Subcutaneous injection |
| Varilrix™ | BIOLOGICAL | Subcutaneous injection |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination. * Written...