drugset / Trial / NCT06740630

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age

NCT06740630

Phase 3 Recruiting 1840 enrolled GlaxoSmithKline
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2025-01-10
Primary completion
2026-12-25
Completion
2027-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Investigational varicella vaccine Vaccine Subcutaneous
Comparator Marketed varicella vaccine Vaccine Subcutaneous
Background Havrix Vaccine Intramuscular
Background MMR vaccine Vaccine Subcutaneous
Background PCV (pneumococcal conjugate vaccine) 13 Vaccine Intramuscular
Background PCV20 Vaccine Intramuscular
Background V114 Vaccine Intramuscular

Indications