Actively Recruiting
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
Led by GlaxoSmithKline · Updated on 2025-12-04
900
Participants Needed
12
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
CONDITIONS
Official 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...
- Participant's parent(s) or legal representatives who can comply with study requirements including diary completion and follow-up visits
- Written or witnessed/thumb printed informed consent obtained from parent(s)/legal representatives
- Healthy children based on medical history and clinical exam
- Male or female children aged 12 to 15 months (from 1 year birthday up to the day before 16 months)
- For children in countries where pneumococcal conjugate vaccine (PCV) is recommended at 12 to 15 months: previously received primary PCV series in the first year of life with last dose at least 60 days before study vaccine administration
You will not qualify if you...
- History of hypersensitivity to any vaccine components including neomycin, gelatin, or latex
- Confirmed or suspected immunosuppressive or immunodeficient condition
- Major congenital defects
- Recurrent uncontrolled neurological disorders or seizures
- History of measles, mumps, rubella, or varicella disease
- Active untreated tuberculosis
- Bleeding disorders such as thrombocytopenia or coagulation problems
- Condition making intramuscular injection unsafe
- Other clinical conditions posing increased risk as judged by investigator
- Use of investigational or non-registered products within 30 days before vaccination or planned use during study
- Chronic or planned immune-modifying drug use
- Previous vaccination against measles, mumps, rubella, varicella, or hepatitis A viruses
- For PCV countries: having received a booster dose of any PCV
- Concurrent participation in other clinical studies involving investigational or non-investigational interventions
- Study personnel or their immediate family members
- Children in care
- Household members with immunocompromised individuals
- Pregnant women without documented varicella history
- Newborn infants of mothers without documented varicella history
- Newborn infants born before 28 weeks of gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 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
Pharr, Texas, United States, 78577
Actively Recruiting
12
GSK Investigational Site
Alken, Belgium, 3570
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
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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