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A Study on the Immune Response and 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 the consistency of immune response to three different lots of GSK's investigational varicella vaccine (VNS Vaccine), and to compare the safety and immune response of VNS vaccine to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted in healthy children aged 12 to 15 months, who have neither contracted varicella nor received a varicella vaccination.
Official title: A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and 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
1840
Start Date
2025-01-10
Completion Date
2027-05-13
Last Updated
2025-03-07
Healthy Volunteers
Yes
Conditions
Interventions
Investigational varicella vaccine_Lot 1
Investigational varicella vaccine of Lot 1 administered subcutaneously.
Investigational varicella vaccine_Lot 2
Investigational varicella vaccine of Lot 2 administered subcutaneously.
Investigational varicella vaccine_Lot 3
Investigational varicella vaccine of Lot 3 administered subcutaneously.
Marketed varicella vaccine_Lot 1
Marketed varicella vaccine of Lot 1 administered subcutaneously.
Marketed varicella vaccine_Lot 2
Marketed varicella vaccine of Lot 2 administered subcutaneously.
MMR vaccine
MMR vaccine co-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 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 (5)
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Bingham Farms, Michigan, United States
GSK Investigational Site
McAllen, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Layton, Utah, United States