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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00751348 | Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136 | PHASE3 | COMPLETED | 475 | — | — | Oct 1, 2008 | May 27, 2010 | Jun 8, 2018 | 13 | South Korea |
Seroconversion was defined as the appearance of antibodies \[i.e. titer greater than or equal to (≥) the cut-off value\] in the sera of subjects seronegative \[i.e. titer below (\<) cut-off value\] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.
| Arm | Type | Description |
|---|---|---|
| PRIORIX-TETRA GROUP | EXPERIMENTAL | Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm. |
| PRIORIX + VARILRIX GROUP | ACTIVE_COMPARATOR | Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively. |
| Name | Type | Description |
|---|---|---|
| PriorixTM | BIOLOGICAL | Subcutaneous administration in left upper arm |
| VarilrixTM | BIOLOGICAL | Subcutaneous administration in right upper arm |
| Priorix-Tetra® | BIOLOGICAL | Subcutaneous injection in left upper arm |
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. * A male or female between, and including 11 and 24 months of age, at the time of the vaccination. * Written informed ...