NCT06693895

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

A Phase 3a, Observer-blind, Randomized, Controlled Study to Evaluate the Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess how well-tolerated GSK's investigational varicella vaccine (VNS Vaccine) is, in comparison to an already approved varicella vaccine (VV) known as Varivax. The study will be conducted on healthy children aged 12 to 15 months, and who have neither contracted varicella nor received a varicella vaccination.

Conditions

• Chickenpox

Interventions

Type	Name	Description
BIOLOGICAL	Investigational varicella vaccine	1 dose of investigational varicella vaccine administered subcutaneously.
BIOLOGICAL	Marketed varicella vaccine	1 dose of marketed varicella vaccine administered subcutaneously.
BIOLOGICAL	Measles, mumps, and rubella vaccine	1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly.
BIOLOGICAL	Hepatitis A vaccine	1 dose of hepatitis A vaccine co-administered intramuscularly.
BIOLOGICAL	PCV (pneumococcal conjugate vaccine) 13	1 dose of 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	1 dose of 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	1 dose of 15-valent pneumococcal conjugate (Vaxneuvance) 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: 2024-11-26
• Primary completion: 2026-07-01
• Completion: 2026-11-23
• First posted: 2024-11-18
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study