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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02570126 | A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age. | PHASE3 | COMPLETED | 1,236 | — | — | Nov 13, 2015 | Oct 25, 2016 | Nov 25, 2019 | 23 | Estonia, Germany +3 |
Fever was defined as axillary temperature above (\>) 39.0 °C (\> 102.2°F)
| Arm | Type | Description |
|---|---|---|
| VAR_HSA_F Group | EXPERIMENTAL | 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm |
| VAR Group | ACTIVE_COMPARATOR | 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm |
| Name | Type | Description |
|---|---|---|
| Varilrix HSA-free | BIOLOGICAL | 2 doses will be administered, one at Day 0 and the other at Day 42 |
| Varilrix™ | BIOLOGICAL | 2 doses will be administered, one at Day 0 and the other at Day 42 |
Inclusion Criteria: * Subjects' parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccinat...