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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

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.

Conditions

• Chickenpox

Interventions

Type	Name	Description
BIOLOGICAL	Investigational varicella vaccine	Investigational varicella vaccine administered subcutaneously.
BIOLOGICAL	Marketed varicella vaccine	Marketed varicella vaccine administered subcutaneously.
BIOLOGICAL	MMR vaccine	MMR vaccine co-administered subcutaneously or intramuscularly.
BIOLOGICAL	Hepatitis A vaccine	Hepatitis A vaccine co-administered intramuscularly.
BIOLOGICAL	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.
BIOLOGICAL	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.
BIOLOGICAL	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.

Timeline

• Start date: 2025-05-15
• Primary completion: 2026-12-14
• Completion: 2027-05-03
• First posted: 2025-02-03
• Last updated: 2025-12-04

Locations

3 sites across 1 country: Dominican Republic

Regulatory

• FDA-regulated drug study