drugset / Trial / NCT06806137

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

NCT06806137

Phase 3 Recruiting 600 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2025-05-15
Primary completion
2026-12-14
Completion
2027-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Investigational varicella vaccine Vaccine Subcutaneous
Subject 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