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

A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and 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: 1,840 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

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.

Conditions

• Chickenpox

Interventions

Type	Name	Description
BIOLOGICAL	Investigational varicella vaccine_Lot 1	Investigational varicella vaccine of Lot 1 administered subcutaneously.
BIOLOGICAL	Investigational varicella vaccine_Lot 2	Investigational varicella vaccine of Lot 2 administered subcutaneously.
BIOLOGICAL	Investigational varicella vaccine_Lot 3	Investigational varicella vaccine of Lot 3 administered subcutaneously.
BIOLOGICAL	Marketed varicella vaccine_Lot 1	Marketed varicella vaccine of Lot 1 administered subcutaneously.
BIOLOGICAL	Marketed varicella vaccine_Lot 2	Marketed varicella vaccine of Lot 2 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: 2025-01-10
• Primary completion: 2026-12-25
• Completion: 2027-05-13
• First posted: 2024-12-18
• Last updated: 2025-03-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study