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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00892775 | Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and Rubella Working Seeds | PHASE2 | COMPLETED | 501 | — | — | Jun 3, 2009 | Dec 13, 2010 | Nov 15, 2019 | 6 | Singapore, Taiwan |
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
| Arm | Type | Description |
|---|---|---|
| Priorix-Tetra new WS Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. |
| Priorix-Tetra current WS Group | EXPERIMENTAL | Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12. |
| Name | Type | Description |
|---|---|---|
| Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine) | BIOLOGICAL | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
| GSK Biologicals' 208136, new formulation | BIOLOGICAL | Vaccine will be administered subcutaneously in the left upper arm (deltoid region) |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 11 and 21...