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NCT06693895PHASE3RecruitingAccepts Healthy Volunteers

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

GlaxoSmithKline

Start Date

11/26/2024

Completion Date

11/23/2026

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.

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 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 (no laboratory testing required). * Hypersensitivity to latex. * 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. * 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

BIOLOGICAL

Marketed varicella vaccine

BIOLOGICAL

Measles, mumps, and rubella vaccine

BIOLOGICAL

Hepatitis A vaccine

BIOLOGICAL

PCV (pneumococcal conjugate vaccine) 13

BIOLOGICAL

PCV 20

BIOLOGICAL

Vaxneuvance

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Conditions

Chickenpox

Locations

GSK Investigational Site

Phoenix, Arizona 85006

United States

GSK Investigational Site

Tucson, Arizona 85741

United States

GSK Investigational Site

Huntington Park, California 90057

United States

GSK Investigational Site

National City, California 91950

United States

GSK Investigational Site

West Covina, California 91790

United States

GSK Investigational Site

Hialeah, Florida 33012

United States

GSK Investigational Site

Miami, Florida 33142

United States

GSK Investigational Site

Chicago, Illinois 60621

United States

GSK Investigational Site

El Dorado, Kansas 67042

United States

GSK Investigational Site

Lafayette, Louisiana 70508

United States

GSK Investigational Site

Mankato, Minnesota 56002

United States

GSK Investigational Site

Lincoln, Nebraska 68516

United States

GSK Investigational Site

Cincinnati, Ohio 45245

United States

GSK Investigational Site

Dallas, Texas 75230-2571

United States

GSK Investigational Site

Dallas, Texas 75235

United States

GSK Investigational Site

Houston, Texas 77065

United States

GSK Investigational Site

Richmond, Texas 77469

United States

GSK Investigational Site

Richmond, Texas 77469

United States

GSK Investigational Site

San Antonio, Texas 78244

United States

GSK Investigational Site

Roy, Utah 84067

United States

GSK Investigational Site

Syracuse, Utah 84075

United States

GSK Investigational Site

Richmond, Virginia 23294

United States

GSK Investigational Site

Vienna, Virginia 22180

United States

GSK Investigational Site

Burgas, 8008

Bulgaria

GSK Investigational Site

Gabrovo, 5300

Bulgaria

GSK Investigational Site

Kyustendil, 2500

Bulgaria

GSK Investigational Site

Plovdiv, 4002

Bulgaria

GSK Investigational Site

Rousse, 7000

Bulgaria

GSK Investigational Site

Sevlievo, 5400

Bulgaria

GSK Investigational Site

Yambol, 8600

Bulgaria

GSK Investigational Site

Aarhus N, 8200

Denmark

GSK Investigational Site

Copenhagen, DK-2100

Denmark

GSK Investigational Site

Hvidovre, 2650

Denmark

GSK Investigational Site

Odense C, DK-5000

Denmark

GSK Investigational Site

Tallinn, 10615

Estonia

GSK Investigational Site

Tallinn, 10617

Estonia

GSK Investigational Site

Hong Kong, 00852

Hong Kong

GSK Investigational Site

Shatin,

Hong Kong

GSK Investigational Site

Kaunas, 47116

Lithuania

GSK Investigational Site

Kaunas, LT-48259

Lithuania

GSK Investigational Site

Durango, 34000

Mexico

GSK Investigational Site

Tlalpan, 14340

Mexico

GSK Investigational Site

Tlalpan, 14340

Mexico

GSK Investigational Site

Bydgoszcz, 85-796

Poland

GSK Investigational Site

Trzebnica, 55-100

Poland

GSK Investigational Site

Warsaw, 02-172

Poland