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A Study on the Immune Response and Safety of the Second Dose of an Investigational Chickenpox Vaccine When Given to Healthy Children 3 Months After a First Dose at 12 to 15 Months of Age
Sponsor: GlaxoSmithKline
Summary
The purpose of this study is to evaluate the immune response and safety of GSKs investigational varicella vaccine (VNS Vaccine) compared to an already approved varicella vaccine, Varivax (VV), when administered as second dose to healthy children. 3 months after first dose at 12 to 15 months. The study will be conducted in children who have not previously contracted varicella or received a varicella vaccination.
Official title: A Phase 3a, Observer-blind, Randomized, Controlled, Study to Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, When Given as a Second Dose to Healthy Children, 3 Months After the Administration of a First Dose at 12 to 15 Months of Age
Key Details
Gender
All
Age Range
12 Months - 15 Months
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2025-05-15
Completion Date
2027-05-03
Last Updated
2025-12-04
Healthy Volunteers
Yes
Conditions
Interventions
Investigational varicella vaccine
Investigational varicella vaccine administered subcutaneously.
Marketed varicella vaccine
Marketed varicella vaccine 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 (3)
GSK Investigational Site
Salvaleón de Higüey, La Altagracia Province, Dominican Republic
GSK Investigational Site
Constanza, Dominican Republic
GSK Investigational Site
Santo Domingo Oeste, Dominican Republic