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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00568334 | Study of Two Formulations of GSK Biologicals' Varicella Vaccine | PHASE2 | COMPLETED | 244 | — | — | Nov 1, 2007 | Apr 29, 2008 | Jun 8, 2018 | 13 | Czechia, Hungary |
Antibody titers have been assessed by immunofluorescence assay (IFA) and presented as geometric mean titers (GMTs), for initially seronegative subjects \[with anti-VZV titer below (\<) 1:4\].
Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL), for initially seronegative subjects \[with anti-VZV concentration below (\<) 25 mIU/mL\].
| Arm | Type | Description |
|---|---|---|
| VARILRIX HSA-FREE GROUP | EXPERIMENTAL | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine produced without human serum albumin (HSA-Free), administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
| VARILRIX GROUP | EXPERIMENTAL | Healthy male or female children between, and including, 11 and 21 months of age, who received 2 doses of Varilrix™ vaccine, administered subcutaneously into the deltoid region of the left upper arm, at Day 0 and Day 43-57 (Week 6). |
| Name | Type | Description |
|---|---|---|
| Varilrix (inactivated varicella vaccine) | BIOLOGICAL | subcutaneously injection |
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...