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RECRUITING
NCT06855160
PHASE3

A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine and a Marketed Measles, Mumps and Rubella Vaccine When Administered as Intramuscular Injection to Healthy Children 12 to 15 Months of Age

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.

Official title: A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given 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

900

Start Date

2025-04-17

Completion Date

2027-02-02

Last Updated

2025-12-04

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

Candidate varicella vaccine

Investigational varicella vaccine administered intramuscularly.

BIOLOGICAL

Marketed varicella vaccine

Marketed varicella vaccine administered subcutaneously.

BIOLOGICAL

MMR vaccine

MMR vaccine 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 Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.

Locations (12)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Huntington Park, California, United States

GSK Investigational Site

Sherman Oaks, California, United States

GSK Investigational Site

Coral Gables, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

GSK Investigational Site

Idaho Falls, Idaho, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Lewisville, Texas, United States

GSK Investigational Site

Pharr, Texas, United States

GSK Investigational Site

Alken, Belgium