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A Study on the Safety of an Investigational Chickenpox Vaccine, When Given to Healthy Children, 12 to 15 Months of Age
Sponsor: GlaxoSmithKline
Summary
The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.
Official title: A Phase 3a, Observer-blind, Randomized, Controlled Study to Evaluate the Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered 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
750
Start Date
2024-11-26
Completion Date
2026-11-23
Last Updated
2026-05-29
Healthy Volunteers
Yes
Conditions
Interventions
Investigational varicella vaccine
1 dose of investigational varicella vaccine administered subcutaneously.
Marketed varicella vaccine
1 dose of marketed varicella vaccine administered subcutaneously.
Measles, mumps, and rubella vaccine
1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.
Hepatitis A vaccine
1 dose of hepatitis A vaccine co-administered intramuscularly.
PCV (pneumococcal conjugate vaccine) 13
1 dose of 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
1 dose of 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
1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) 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.
Locations (46)
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Huntington Park, California, United States
GSK Investigational Site
National City, California, United States
GSK Investigational Site
West Covina, California, United States
GSK Investigational Site
Hialeah, Florida, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
El Dorado, Kansas, United States
GSK Investigational Site
Lafayette, Louisiana, United States
GSK Investigational Site
Mankato, Minnesota, United States
GSK Investigational Site
Lincoln, Nebraska, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States
GSK Investigational Site
Richmond, Texas, United States
GSK Investigational Site
Richmond, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Roy, Utah, United States
GSK Investigational Site
Syracuse, Utah, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Vienna, Virginia, United States
GSK Investigational Site
Burgas, Bulgaria
GSK Investigational Site
Gabrovo, Bulgaria
GSK Investigational Site
Kyustendil, Bulgaria
GSK Investigational Site
Plovdiv, Bulgaria
GSK Investigational Site
Rousse, Bulgaria
GSK Investigational Site
Sevlievo, Bulgaria
GSK Investigational Site
Yambol, Bulgaria
GSK Investigational Site
Aarhus N, Denmark
GSK Investigational Site
Copenhagen, Denmark
GSK Investigational Site
Hvidovre, Denmark
GSK Investigational Site
Odense C, Denmark
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Tallinn, Estonia
GSK Investigational Site
Hong Kong, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Kaunas, Lithuania
GSK Investigational Site
Kaunas, Lithuania
GSK Investigational Site
Durango, Mexico
GSK Investigational Site
Tlalpan, Mexico
GSK Investigational Site
Tlalpan, Mexico
GSK Investigational Site
Bydgoszcz, Poland
GSK Investigational Site
Trzebnica, Poland
GSK Investigational Site
Warsaw, Poland