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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
Sponsor: GlaxoSmithKline
Summary
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.
Official title: A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age
Key Details
Gender
All
Age Range
12 Months - 15 Months
Study Type
INTERVENTIONAL
Enrollment
900
Start Date
2025-04-17
Completion Date
2027-02-02
Last Updated
2025-12-04
Healthy Volunteers
Yes
Conditions
Interventions
Candidate varicella vaccine
Investigational varicella vaccine administered intramuscularly.
Marketed varicella vaccine
Marketed varicella vaccine administered subcutaneously.
MMR vaccine
MMR vaccine administered subcutaneously or intramuscularly.
Hepatitis A vaccine
Hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
PCV 20
The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Vaxneuvance
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Locations (12)
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Huntington Park, California, United States
GSK Investigational Site
Sherman Oaks, California, United States
GSK Investigational Site
Coral Gables, Florida, United States
GSK Investigational Site
Miami Lakes, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Idaho Falls, Idaho, United States
GSK Investigational Site
Dayton, Ohio, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Lewisville, Texas, United States
GSK Investigational Site
Pharr, Texas, United States
GSK Investigational Site
Alken, Belgium