Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Varilrix · 1 trial · 1 indication
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...
Varilrix is a vaccine being studied for the prevention of varicella, the disease caused by the varicella-zoster virus. It is currently in Phase 2 clinical development and is being investigated for use in children as young as 11 months.
Varilrix is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
Varilrix is in Phase 2 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. One Phase 2 trial has been completed, and the vaccine remains under evaluation.
Varilrix has been studied in one completed Phase 2 clinical trial, identified as NCT00568334. This trial evaluated two formulations of the varicella vaccine in 244 healthy participants in Czechia and Hungary.
Varilrix is a varicella vaccine, meaning it is designed to protect against chickenpox. It is being developed as a preventive measure for varicella infection, and the clinical trial data supports its potential use in this indication.