Approval Probability
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Varilrix HSA-free · 1 trial · 2 indications
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...
Varilrix HSA-free is a varicella vaccine being studied for the prevention of chicken-pox illness, also known as varicella virus disease. It is intended for use in healthy children aged 12 to 23 months, administered as a two-dose course.
Varilrix HSA-free is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the vaccine's safety and immune response in children.
Varilrix HSA-free is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed to assess its safety and immunogenicity in healthy children.
Varilrix HSA-free has one completed Phase 3 clinical trial, identified as NCT02570126. This randomized, double-blind, active-controlled study enrolled 1,236 healthy children aged 12 to 23 months to evaluate the safety and immune response of two types of GSK varicella vaccines given as a two-dose course.
Varilrix HSA-free is a formulation of GSK's varicella vaccine, with the HSA-free designation indicating it is free of human serum albumin. It is being studied for the same indication as other varicella vaccines, but it is a distinct investigational product in clinical development.