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RECRUITING
NCT06693895
PHASE3

A Study on the 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 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.

Official title: 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

Key Details

Gender

All

Age Range

12 Months - 15 Months

Study Type

INTERVENTIONAL

Enrollment

750

Start Date

2024-11-26

Completion Date

2026-11-23

Last Updated

2026-05-29

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (46)

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Huntington Park, California, United States

GSK Investigational Site

National City, California, United States

GSK Investigational Site

West Covina, California, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

El Dorado, Kansas, United States

GSK Investigational Site

Lafayette, Louisiana, United States

GSK Investigational Site

Mankato, Minnesota, United States

GSK Investigational Site

Lincoln, Nebraska, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Richmond, Texas, United States

GSK Investigational Site

Richmond, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Roy, Utah, United States

GSK Investigational Site

Syracuse, Utah, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Vienna, Virginia, United States

GSK Investigational Site

Burgas, Bulgaria

GSK Investigational Site

Gabrovo, Bulgaria

GSK Investigational Site

Kyustendil, Bulgaria

GSK Investigational Site

Plovdiv, Bulgaria

GSK Investigational Site

Rousse, Bulgaria

GSK Investigational Site

Sevlievo, Bulgaria

GSK Investigational Site

Yambol, Bulgaria

GSK Investigational Site

Aarhus N, Denmark

GSK Investigational Site

Copenhagen, Denmark

GSK Investigational Site

Hvidovre, Denmark

GSK Investigational Site

Odense C, Denmark

GSK Investigational Site

Tallinn, Estonia

GSK Investigational Site

Tallinn, Estonia

GSK Investigational Site

Hong Kong, Hong Kong

GSK Investigational Site

Shatin, Hong Kong

GSK Investigational Site

Kaunas, Lithuania

GSK Investigational Site

Kaunas, Lithuania

GSK Investigational Site

Durango, Mexico

GSK Investigational Site

Tlalpan, Mexico

GSK Investigational Site

Tlalpan, Mexico

GSK Investigational Site

Bydgoszcz, Poland

GSK Investigational Site

Trzebnica, Poland

GSK Investigational Site

Warsaw, Poland