Back to Trials
NCT06740630PHASE3RecruitingAccepts Healthy Volunteers

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

GlaxoSmithKline

Start Date

1/10/2025

Completion Date

5/17/2027

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * Participant's parent(s) Legally acceptable representatives /(LAR\[s\]), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits). * Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior to performance of any study-specific procedure. * Healthy participants as established by medical history and clinical examination before entering into the study. * A male or female between, and including, 12 to 15 months of age (i.e., from the day of 1-year birthday until the day before 16 months of age) at the time of the administration of study interventions. * Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions: * Participant who previously received the primary series of PCV in the first year of life with last dose at least 60 days prior to study entry. Exclusion Criteria: * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Hypersensitivity to latex. * Major congenital defects, as assessed by the investigator. * Recurrent history of uncontrolled neurological disorders or seizures. * History of varicella disease. * Active untreated tuberculosis. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. * Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions administration (Day -29 to Day 1), or their planned use during the study period. * Planned administration of a vaccine in the period starting 30 days before the dose and ending 43 days after the dose of study interventions administration\* (Visit 2) with the exception of inactivated influenza vaccine which may be given at any time during the study and administered at a different location than the study interventions. Any other age-appropriate vaccine may be given starting at Visit 2 and anytime thereafter. \*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified * Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study. * Up to 90 days prior to the study intervention administration: * For corticosteroids, this will mean prednisone equivalent \>=0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/or any blood products or plasma derivatives. * Up to 180 days prior to study interventions administration: long acting immune-modifying drugs including among others immunotherapy (e.g., tumor necrosis factor-inhibitors), monoclonal antibodies (except the ones not interfering with the immune response to the study vaccines, e.g., nirsevimab), antitumoral medication. * Previous vaccination against measles, mumps, and rubella. * Previous vaccination against hepatitis A virus. * Previous vaccination against varicella virus. * Only for children in countries where PCV is recommended at 12 to 15 months of age as per national immunization schedule and provided as part of the study interventions, participant who previously received a booster dose of any PCV. * Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). * Child in care. * Any study personnel's immediate dependents, family, or household members. * Participants with the following high-risk individuals in their household: * Immunocompromised individuals. * Pregnant women without documented history of varicella. * Newborn infants of mothers without documented history of varicella. * Newborn infants born less than (\<) 28 weeks of gestation.

Interventions

BIOLOGICAL

Investigational varicella vaccine_Lot 1

BIOLOGICAL

Investigational varicella vaccine_Lot 2

BIOLOGICAL

Investigational varicella vaccine_Lot 3

BIOLOGICAL

Marketed varicella vaccine_Lot 1

BIOLOGICAL

Marketed varicella vaccine_Lot 2

BIOLOGICAL

MMR vaccine

BIOLOGICAL

Hepatitis A vaccine

BIOLOGICAL

PCV (pneumococcal conjugate vaccine) 13

BIOLOGICAL

PCV 20

BIOLOGICAL

Vaxneuvance

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Chickenpox

Locations

GSK Investigational Site

Mobile, Alabama 36608

United States

GSK Investigational Site

Hot Springs, Arkansas 71913

United States

GSK Investigational Site

Sherwood, Arkansas 72120

United States

GSK Investigational Site

Canoga Park, California 91304

United States

GSK Investigational Site

Covina, California 91723

United States

GSK Investigational Site

Fullerton, California 92835

United States

GSK Investigational Site

Long Beach, California 90807

United States

GSK Investigational Site

Los Angeles, California 90057

United States

GSK Investigational Site

Paramount, California 90723

United States

GSK Investigational Site

Sacramento, California 95823

United States

GSK Investigational Site

Ventura, California 93003

United States

GSK Investigational Site

Walnut Creek, California 94598

United States

GSK Investigational Site

Winnetka, California 91306

United States

GSK Investigational Site

Miami, Florida 33176

United States

GSK Investigational Site

Miami, Florida 33184

United States

GSK Investigational Site

Miami Lakes, Florida 33014

United States

GSK Investigational Site

Spring Hill, Florida 34609

United States

GSK Investigational Site

Tampa, Florida 33613

United States

GSK Investigational Site

Covington, Georgia 70433

United States

GSK Investigational Site

Ammon, Idaho 83406

United States

GSK Investigational Site

Moline, Illinois 61265

United States

GSK Investigational Site

South Bend, Indiana 46617

United States

GSK Investigational Site

Topeka, Kansas 66606

United States

GSK Investigational Site

Bardstown, Kentucky 40004

United States

GSK Investigational Site

Louisville, Kentucky 40202-1822

United States

GSK Investigational Site

Haughton, Louisiana 71037

United States

GSK Investigational Site

Fall River, Massachusetts 02721-1735

United States

GSK Investigational Site

Bingham Farms, Michigan 48025

United States

GSK Investigational Site

Jefferson City, Missouri 65109

United States

GSK Investigational Site

Lincoln, Nebraska 68505

United States

GSK Investigational Site

Lincoln, Nebraska 68510

United States

GSK Investigational Site

Lincoln, Nebraska 68516

United States

GSK Investigational Site

The Bronx, New York 10456

United States

GSK Investigational Site

Charlotte, North Carolina 28203

United States

GSK Investigational Site

Monroe, North Carolina 28112

United States

GSK Investigational Site

Cleveland, Ohio 44121

United States

GSK Investigational Site

Dayton, Ohio 45424

United States

GSK Investigational Site

Chickasha, Oklahoma 73018

United States

GSK Investigational Site

Tulsa, Oklahoma 74137

United States

GSK Investigational Site

Gresham, Oregon 97030

United States

GSK Investigational Site

Charleston, South Carolina 29407

United States

GSK Investigational Site

Charleston, South Carolina 29414

United States

GSK Investigational Site

Greenville, South Carolina 29607

United States

GSK Investigational Site

Simpsonville, South Carolina 29681

United States

GSK Investigational Site

Beaumont, Texas 77701

United States

GSK Investigational Site

Burleson, Texas 76028

United States

GSK Investigational Site

Corpus Christi, Texas 78404

United States

GSK Investigational Site

Dallas, Texas 75230-2571

United States

GSK Investigational Site

Dallas, Texas 75251

United States

GSK Investigational Site

Houston, Texas 77030

United States

GSK Investigational Site

Houston, Texas 77087

United States

GSK Investigational Site

McAllen, Texas 78504

United States

GSK Investigational Site

Mesquite, Texas 75149

United States

GSK Investigational Site

Layton, Utah 84041

United States

GSK Investigational Site

Layton, Utah 84041

United States

GSK Investigational Site

Murray, Utah 84107

United States

GSK Investigational Site

Pleasant View, Utah 84404

United States

GSK Investigational Site

South Jordan, Utah 84095

United States

GSK Investigational Site

West Jordan, Utah 84088

United States

GSK Investigational Site

Richmond, Virginia 23226

United States

GSK Investigational Site

Brussels, 1200

Belgium

GSK Investigational Site

Ghent, 9000

Belgium

GSK Investigational Site

Gozée, 6534

Belgium

GSK Investigational Site

Leuven, 3000

Belgium

GSK Investigational Site

Liège, 4000

Belgium

GSK Investigational Site

Cali, 760042

Colombia

GSK Investigational Site

Medellín, 050021

Colombia

GSK Investigational Site

Jindřichův Hradec, 377 01

Czechia

GSK Investigational Site

Jindřichův Hradec, 37701

Czechia

GSK Investigational Site

Jinočany, 530 12

Czechia

GSK Investigational Site

Ostrava, 708 00

Czechia

GSK Investigational Site

Prague, 160 00

Czechia

GSK Investigational Site

Santo Domingo, 10201

Dominican Republic

GSK Investigational Site

Santo Domingo, 10205

Dominican Republic

GSK Investigational Site

Santo Domingo Oeste, 11114

Dominican Republic

GSK Investigational Site

Paide, 72713

Estonia

GSK Investigational Site

Tartu, 50106

Estonia

GSK Investigational Site

Acapulco, 39670

Mexico

GSK Investigational Site

Hidalgo, 42000

Mexico

GSK Investigational Site

Mexico City, 6750

Mexico

GSK Investigational Site

Mexico City,

Mexico

GSK Investigational Site

Veracruz, 91900

Mexico

GSK Investigational Site

Bydgoszcz, 85-048

Poland

GSK Investigational Site

Częstochowa, 42-217

Poland

GSK Investigational Site

Krakow, 30-363

Poland

GSK Investigational Site

Siemianowice Śląskie, 41103

Poland

GSK Investigational Site

Torun, 87-100

Poland

GSK Investigational Site

Caguas, 00725

Puerto Rico

GSK Investigational Site

Ponce, 00716

Puerto Rico

GSK Investigational Site

San Juan, 00918

Puerto Rico

GSK Investigational Site

San Juan, 907

Puerto Rico

GSK Investigational Site

Bangkok, 10700

Thailand

GSK Investigational Site

Rajathevee, 10400

Thailand

GSK Investigational Site

Abu Dhabi,

United Arab Emirates

GSK Investigational Site

Abu Dhabi,

United Arab Emirates

GSK Investigational Site

Abu Dhabi,

United Arab Emirates

GSK Investigational Site

Al Ain City,

United Arab Emirates