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RECRUITING
NCT06740630
PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

12 Months - 15 Months

Study Type

INTERVENTIONAL

Enrollment

1840

Start Date

2025-01-10

Completion Date

2027-05-13

Last Updated

2025-03-07

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (5)

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Bingham Farms, Michigan, United States

GSK Investigational Site

McAllen, Texas, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Layton, Utah, United States