Actively Recruiting
Study to Evaluate Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax as a Second Dose in Healthy Children Aged 12 to 15 Months
Led by GlaxoSmithKline · Updated on 2026-05-29
600
Participants Needed
6
Research Sites
20 weeks
Total Duration
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AI-Summary
What this Trial Is About
This research aims to evaluate the immune response and safety of an investigational chickenpox vaccine (VNS Vaccine) compared to an already approved vaccine called Varivax (VV). The study focuses on healthy children who have not previously had chickenpox or received a chickenpox vaccine, and takes place when the second dose is given three months after the first dose, which is administered between 12 and 15 months of age. Participants are randomly assigned to one of three groups: one group receives two doses of the Varivax vaccine; another group receives two doses of the investigational VNS vaccine; and the third group receives a first dose of Varivax followed by a second dose of the VNS vaccine. Additional vaccines including measles, mumps, and rubella (MMR), hepatitis A (HAV), and pneumococcal conjugate vaccine (PCV) are given on the first day. In some countries, a second dose of MMR is also given between 15 and 18 months according to national guidelines. During the study, researchers will monitor immune responses by measuring specific antibodies against the chickenpox virus after the second dose, particularly 43 days post-vaccination. They will also track any local or systemic side effects following each vaccine dose, recording adverse events up to nearly nine months after the first dose. The total participation includes multiple visits over this time, ensuring detailed safety and immune response assessment for each child.
CONDITIONS
Brief 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...
- Parent or legal guardian able and willing to comply with study requirements
- Written or witnessed informed consent obtained before study procedures
- Healthy children based on medical history and physical exam
- Male or female aged 12 to 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 entry
You will not qualify if you...
- History of allergic reaction or hypersensitivity to any vaccine component
- Confirmed or suspected immune deficiency
- Allergy to latex
- Major congenital defects
- Recurrent uncontrolled neurological disorders or seizures
- History of chickenpox disease
- Active untreated tuberculosis
- Any condition posing additional risk as judged by investigator
- Use of investigational or unregistered products within 30 days before first dose
- Planned vaccination (except inactivated flu vaccine) from 30 days before first dose to 43 days after second dose
- Chronic use of immune-modifying drugs or planned long-acting immune treatments
- Previous vaccination against measles, mumps, rubella, hepatitis A, or varicella
- For countries recommending PCV at 12 to 15 months: prior booster dose of PCV
- Participation in another clinical study involving investigational or non-investigational interventions
- Child in care
- Immediate family or household members of study personnel
- Household members who are immunocompromised, pregnant without chickenpox history, newborns of mothers without chickenpox history, or very premature infants born before 28 weeks gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 13 weeks
Participants receive two doses of vaccine injections on Day 1 and Day 91. On Day 1, participants also receive one dose each of MMR vaccine, hepatitis A vaccine, and a pneumococcal conjugate vaccine. In some countries, a second dose of MMR vaccine may be co-administered between 15 to 18 months of age according to the national immunization schedule.
2 visits (Day 1 and Day 91, in-person)
Duration - Up to 12 weeks after second dose
Participants are monitored for safety and immune response after the second vaccine dose, including assessment of adverse events and immune response markers.
Multiple follow-up visits up to Day 133 and safety monitoring through Day 271
Trial Site Locations
Total: 6 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
4
GSK Investigational Site
San Pedro Sula, Honduras, 21104
Actively Recruiting
5
GSK Investigational Site
Tegucigalpa, Honduras, 11101
Actively Recruiting
6
GSK Investigational Site
Tegucigalpa, Honduras, 2449
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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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