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Recruiting Phase 3 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

Trial Parameters

Condition Chickenpox
Sponsor GlaxoSmithKline
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 600
Sex ALL
Min Age 12 Months
Max Age 15 Months
Start Date 2025-05-15
Completion 2026-12-14
Interventions
Investigational varicella vaccineMarketed varicella vaccineMMR vaccine

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Participant's parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol * Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure. * Healthy participants as established by medical history and clinical examination before entering into the study. * A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1 year birthday until the day before 16 months of age) at the time of the administration of the first study interventions. * Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry. Exclusion Crite

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