Actively Recruiting
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age
Led by GlaxoSmithKline · Updated on 2025-03-07
1840
Participants Needed
5
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
CONDITIONS
Official Title
A Study on the Immune Response and 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 legal representative willing and able to follow study requirements including diary completion and follow-up visits
- Written informed consent obtained from parent or legal representative before any study procedures
- Healthy children based on medical history and clinical exam
- Male or female aged 12 to 15 months at time of vaccination
- For children in countries recommending PCV at 12 to 15 months, 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 study vaccine component
- Immunosuppressive or immunodeficient condition
- Allergy to latex
- Major congenital defects
- Recurrent uncontrolled neurological disorders or seizures
- History of chickenpox disease
- Active untreated tuberculosis
- Any condition posing additional risk for study participation
- Use of investigational or non-registered products within 30 days before vaccination or planned during study
- Planned vaccination (other than inactivated influenza vaccine) within 30 days before or 43 days after study vaccine
- Chronic or planned immune-modifying drug use up to study end, including corticosteroids above specified doses
- Prior vaccination against MMR, hepatitis A, or varicella viruses
- For countries recommending PCV at 12 to 15 months, prior booster dose of any PCV
- Participation in other clinical studies with investigational or non-investigational interventions
- Child in care
- Immediate family or household members employed by study site
- Household members who are immunocompromised, pregnant without varicella history, newborns of mothers without varicella history, or very premature infants born before 28 weeks gestation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
GSK Investigational Site
Tampa, Florida, United States, 33613
Actively Recruiting
2
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
Actively Recruiting
3
GSK Investigational Site
McAllen, Texas, United States, 78504
Actively Recruiting
4
GSK Investigational Site
Layton, Utah, United States, 84041
Actively Recruiting
5
GSK Investigational Site
Layton, Utah, United States, 84041
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
5
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