Actively Recruiting
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age
Led by GlaxoSmithKline · Updated on 2025-01-20
750
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.
CONDITIONS
Official Title
A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legally acceptable representative can comply with study requirements including diaries and follow-up visits
- Written or witnessed informed consent from parent or legal representative before any study procedure
- Healthy child based on medical history and clinical exam
- Male or female child aged 12 to 15 months at time of vaccination
- For children in countries where pneumococcal conjugate vaccine (PCV) is recommended at 12 to 15 months and given in the study: must have completed primary PCV series in first year of life with last dose at least 60 days before study entry
You will not qualify if you...
- History of allergic reaction or hypersensitivity to any component of the study vaccines
- Known or suspected immune system problems
- Allergy to latex
- History of uncontrolled neurological disorders or seizures
- Previous chickenpox disease
- Active untreated tuberculosis
- Any condition posing extra risk per investigator's opinion
- Use of any investigational or non-registered drug, vaccine, or invasive device within 30 days before vaccination or planned use during study
- Planned vaccines other than study vaccines or inactivated influenza vaccine from 30 days before to 43 days after vaccination
- Chronic or planned use of immune modifying drugs (over 14 days total) or long-acting immune treatments up to study end
- Previous vaccination against measles, mumps, rubella, hepatitis A, or varicella
- For children receiving PCV as part of study in countries recommending it: previous PCV booster dose
- Participation in another clinical study involving investigational or non-investigational interventions
- Child in care
- Immediate family or household members who are study staff
- Household members who are immunocompromised, pregnant without documented varicella history, newborns of mothers without documented varicella history, or newborns born before 28 weeks gestation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
GSK Investigational Site
West Covina, California, United States, 91790
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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