Recent Updates
Recently added Catalysts

Varilrix

Phase 3

Varicella | Vaccine | Infectious Disease |GSK plc|Trials Updated: Jun 8, 2018

Varilrix development status

Highest phase Phase 3 (NCT02570126)
Phase scored for GSKPhase 2
Registered trials 3 across 1 sponsor since Feb 2008

Varilrix target and mechanism

ModalityVaccine

Also known as Varilrix (inactivated varicella vaccine)

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment244

FDA Designations

No designations recorded

Varilrix clinical trials

Varilrix · 1 trial · 1 indication

Phase 2 1
NCT00568334Study of Two Formulations of GSK Biologicals' Varicella VaccineVaricella
COMPLETED244 Analytics
PHASE2COMPLETED
Study of Two Formulations of GSK Biologicals' Varicella Vaccine
VaricellaUnlock trial analytics

Study Endpoints

Primary Endpoints

Antibody Titers Against Varicella Zoster Virus (VZV)
At 43-57 days after the first vaccine dose (Week 6)

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 Against Varicella Zoster Virus (VZV)
At 43-57 days after the first vaccine dose (Week 6)

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 \[with anti-VZV concentration below (\<) 25 mIU/mL\].

Secondary Endpoints

Number of Seroconverted Subjects for Varicella Antibodies
At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
Number of Subjects With Anti-VZV Antibody Concentrations Above Cut-off Values
At 43-57 days post-Dose 1 (Week 6) and 86-114 days post-Dose 2 (Week 12)
Antibody Titers Against Varicella Zoster Virus (VZV)
At 86-114 days after the second vaccine dose (Week 12)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
VARILRIX HSA-FREE GROUPEXPERIMENTALHealthy 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 GROUPEXPERIMENTALHealthy 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).

Interventions

NameTypeDescription
Varilrix (inactivated varicella vaccine)BIOLOGICALsubcutaneously injection
Unlock Study Design Details

Eligibility Criteria

Age Range11 Months to 21 Months
SexALL
Healthy VolunteersYes
Study Sites13

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...

Countries:CzechiaHungary
Unlock Eligibility Criteria

Frequently asked questions about Varilrix

What is Varilrix used for?

Varilrix is a varicella vaccine developed by GSK plc for the prevention of varicella, commonly known as chickenpox. It is an inactivated varicella vaccine studied in healthy volunteers, including young children from 11 months of age, in a Phase 2 clinical program.

Who makes Varilrix?

Varilrix is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals conducted the clinical study of two formulations of the vaccine. GSK plc is the sponsor and manufacturer associated with the Varilrix varicella vaccine asset.

What phase is Varilrix in?

Varilrix is in Phase 2 clinical development. One Phase 2 trial has been completed, and no active trials are currently listed. The completed study was a randomized, double-blind, controlled trial of two formulations of GSK Biologicals' varicella vaccine.

What clinical trials is Varilrix in?

Varilrix has been studied in one completed Phase 2 trial, NCT00568334, titled Study of Two Formulations of GSK Biologicals' Varicella Vaccine. The trial enrolled 244 healthy volunteers aged 11 months and older in Czechia and Hungary and was randomized, double-blind, and controlled.

Is Varilrix the same as inactivated varicella vaccine?

Yes. Varilrix is also known as inactivated varicella vaccine and is sometimes written as Varilrix. These names refer to the same GSK plc vaccine asset for varicella. Searches for either name point to the same Phase 2 program.