Actively Recruiting
Evaluation of Investigational Varicella Vaccine and Priorix Compared to Varivax and Priorix in Healthy Children 12 to 15 Months Old
Led by GlaxoSmithKline · Updated on 2026-05-29
911
Participants Needed
22
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the immune response and safety of GlaxoSmithKline's investigational chickenpox vaccine and a marketed measles, mumps, and rubella (MMR) vaccine when given to healthy children aged 12 to 15 months. The study compares these vaccines administered by muscle injection to Merck's chickenpox vaccine given just under the skin. It also assesses the immune response and safety when the GSK vaccines are given together with other routine childhood vaccines. Participants are randomly assigned to receive either the candidate varicella vaccine intramuscularly along with MMR, hepatitis A virus (HAV) vaccine, and a pneumococcal conjugate vaccine (PCV), or the marketed varicella vaccine subcutaneously with the same additional vaccines. The PCV given may be PCV 13, Vaxneuvance, or PCV 20 depending on availability and national recommendations. All vaccines are given on Day 1. Throughout the study, children are monitored for immune responses by measuring antibody levels against varicella zoster virus and MMR antigens at Day 43. Safety is evaluated by tracking any local and systemic reactions in the days following vaccination, as well as any adverse events up to six months after the dose. The study aims to understand both the immune response and safety profile over this period in healthy young children receiving these vaccines.
CONDITIONS
Brief Title
A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent(s) or legal representatives can comply with study requirements such as completing diaries and follow-up visits
- Written or witnessed informed consent obtained from parent(s) or legal representatives before study procedures
- Healthy children based on medical history and clinical exam
- Male or female children aged 12 to 15 months at vaccination
- For countries recommending pneumococcal conjugate vaccine (PCV) at 12 to 15 months, children must have completed the primary PCV series with last dose at least 60 days before vaccination
You will not qualify if you...
- History of allergic reaction or hypersensitivity to vaccine components including neomycin or gelatin
- Any known or suspected immunosuppressive or immunodeficient condition
- Hypersensitivity to latex
- Major congenital defects as judged by investigator
- Recurrent uncontrolled neurological disorders or seizures
- Past infection with measles, mumps, rubella, or varicella
- Active untreated tuberculosis
- Bleeding disorders such as thrombocytopenia or coagulation problems
- Condition making intramuscular injection unsafe
- Any other condition posing additional risk from study participation
- Use of investigational or non-registered products other than study vaccines within 30 days before vaccination
- Chronic use of immune-modifying drugs or planned use during study
- Previous vaccination against measles, mumps, rubella, varicella, or hepatitis A
- Previous booster dose of PCV for children in countries recommending PCV at 12 to 15 months
- Concurrent participation in other clinical studies involving investigational or non-investigational interventions
- Study personnel or immediate family members
- Child in care
- Living with immunocompromised individuals
- Pregnant women without documented varicella history
- Newborn infants of mothers without varicella history
- Newborn 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 - 1 day
Participants receive one dose of the varicella vaccine (either investigational or marketed), one dose of the MMR vaccine, one dose of hepatitis A vaccine, and one dose of pneumococcal conjugate vaccine on Day 1.
1 vaccination visit (in-person)
Duration - Up to 181 days after vaccination
Participants are monitored for immune response and safety after vaccination.
Multiple visits for safety assessments and immune response measurements up to Day 181
Trial Site Locations
Total: 22 locations
1
GSK Investigational Site
Tucson, Arizona, United States, 85704
Actively Recruiting
2
GSK Investigational Site
Huntington Park, California, United States, 90255
Actively Recruiting
3
GSK Investigational Site
Sherman Oaks, California, United States, 91403
Actively Recruiting
4
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Actively Recruiting
5
GSK Investigational Site
Miami Lakes, Florida, United States, 33014
Actively Recruiting
6
GSK Investigational Site
Tampa, Florida, United States, 33612
Actively Recruiting
7
GSK Investigational Site
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
8
GSK Investigational Site
Dayton, Ohio, United States, 45414
Actively Recruiting
9
GSK Investigational Site
Houston, Texas, United States, 77584
Actively Recruiting
10
GSK Investigational Site
Lewisville, Texas, United States, 75067
Actively Recruiting
11
GSK Investigational Site
Mansfield, Texas, United States, 76063
Actively Recruiting
12
GSK Investigational Site
Pharr, Texas, United States, 78577
Actively Recruiting
13
GSK Investigational Site
Richmond, Virginia, United States, 23294
Actively Recruiting
14
GSK Investigational Site
Alken, Belgium, 3570
Actively Recruiting
15
GSK Investigational Site
Tartu, Estonia, 50106
Actively Recruiting
16
GSK Investigational Site
Athens, Greece, 115 27
Withdrawn
17
GSK Investigational Site
Athens, Greece, 11527
Actively Recruiting
18
GSK Investigational Site
Thessaloniki, Greece, 54642
Actively Recruiting
19
GSK Investigational Site
Trzebnica, Poland, 55-100
Actively Recruiting
20
GSK Investigational Site
Brasov, Romania, 500283
Actively Recruiting
21
GSK Investigational Site
Calarasi, Romania, 910160
Actively Recruiting
22
GSK Investigational Site
Chiang Mai, Thailand, 50200
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
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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