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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
2025-01-20
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 (1)
GSK Investigational Site
West Covina, California, United States