NCT05084508

A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age

A Phase II, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Varicella Vaccine at Various Potencies Compared With Varivax, as a First Dose, Administered in Healthy Children in Their Second Year of Life

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 12 Months – 15 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age.

Detailed description

The study aims to demonstrate the immunogenicity of the investigational VNS vaccine at three potencies (VNS\_Low, VNS\_Med, and VNS\_High) compared to the licensed varicella vaccine, Varivax (VV), as a first dose for children aged 12 to 15 months in the US. To ensure more representative data, participants in the VV group are randomized into two lots (VV\_Lot1 and VV\_Lot2), which are analyzed as pooled lots throughout the study. Besides assessing immunogenicity, the study also seeks to generate safety data. In the US, participants will receive additional vaccines: a measles, mumps, and rubella vaccine (MMR), a hepatitis A vaccine (Havrix), and a 13-valent pneumococcal conjugate vaccine (Prevnar 13). Participants outside the US will receive an MMR vaccine (M-M-R II or M-M-RVaxPro, depending on the country), Havrix, and, in some cases, Prevnar 13, but only in countries where it's recommended for children 12-15 months according to local immunization schedules. At the end of the study, or shortly after, GSK provided re-vaccination with a dose of Varivax (VV) to participants who did not meet the pre-specified seroresponse threshold of anti-gE antibody concentration was greater than or equal to (\>=) 300 mIU/mL. Additionally, a second dose of VV and/or Havrix was offered to participants in non-US countries where local health departments do not routinely provide varicella and/or hepatitis A vaccines.

Conditions

• Chickenpox

Interventions

Type	Name	Description
BIOLOGICAL	Investigational varicella vaccine low potency	1 dose of a low-potency investigational varicella vaccine administered subcutaneously.
BIOLOGICAL	Investigational varicella vaccine medium potency	1 dose of a medium-potency investigational varicella vaccine administered subcutaneously.
BIOLOGICAL	Investigational varicella vaccine high potency	1 dose of a high-potency investigational varicella vaccine administered subcutaneously.
BIOLOGICAL	Licensed varicella vaccine Lot 1	1 dose of a licensed varicella vaccine of Lot 1 administered subcutaneously.
BIOLOGICAL	Licensed varicella vaccine Lot 2	1 dose of a licensed varicella vaccine of Lot 2 administered subcutaneously.
BIOLOGICAL	Measles, mumps, and rubella vaccine	1 dose of a measles, mumps, and rubella vaccine administered subcutaneously.
BIOLOGICAL	Hepatitis A vaccine	1 dose of a hepatitis A vaccine administered intramuscularly.
BIOLOGICAL	13-valent pneumococcal conjugate vaccine	1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly.

Timeline

• Start date: 2022-02-03
• Primary completion: 2024-02-09
• Completion: 2024-06-13
• First posted: 2021-10-19
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

51 sites across 6 countries: United States, Estonia, Poland, Puerto Rico, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study