Actively Recruiting
A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age
Led by GlaxoSmithKline · Updated on 2025-12-04
600
Participants Needed
3
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.
CONDITIONS
Official Title
A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant's parent(s) or legal representative can comply with study requirements
- Written or witnessed consent obtained from parent(s) or legal representative before any study procedure
- Healthy child based on medical history and clinical exam
- Child aged between 12 and 15 months at first vaccine dose
- For children in countries recommending PCV at 12 to 15 months, must have completed primary PCV series with last dose at least 60 days before study start
You will not qualify if you...
- History of allergic reaction to any study vaccine component
- Confirmed or suspected immune deficiency or immunosuppressive condition
- Allergic to latex
- Major congenital defects
- 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 drugs or devices within 30 days before first dose
- Planned vaccination 30 days before first dose to 43 days after second dose, except inactivated influenza vaccine given separately
- Chronic use of immune-modifying drugs longer than 14 days or planned long-acting immune treatments up to study end
- Previous vaccination against measles, mumps, rubella, hepatitis A, or varicella virus
- For children in countries with PCV recommendations, previous booster dose of PCV
- Participation in another clinical trial with investigational or non-investigational interventions
- Child in care
- Immediate family or household member of study personnel
- Household includes high-risk individuals such as immunocompromised persons, pregnant women without varicella history, or newborns without varicella history or born before 28 weeks gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
GSK Investigational Site
Salvaleón de Higüey, La Altagracia Province, Dominican Republic, 23000
Actively Recruiting
2
GSK Investigational Site
Constanza, Dominican Republic, 11201
Actively Recruiting
3
GSK Investigational Site
Santo Domingo Oeste, Dominican Republic, 11906
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
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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