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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

2027-05-17

Last Updated

2026-05-29

Healthy Volunteers

Yes

Conditions

Chickenpox

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.

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.

Locations (97)

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Hot Springs, Arkansas, United States

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Sherwood, Arkansas, United States

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Canoga Park, California, United States

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Covina, California, United States

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Fullerton, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Paramount, California, United States

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Sacramento, California, United States

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Ventura, California, United States

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Walnut Creek, California, United States

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Winnetka, California, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Spring Hill, Florida, United States

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Tampa, Florida, United States

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Covington, Georgia, United States

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Ammon, Idaho, United States

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Moline, Illinois, United States

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South Bend, Indiana, United States

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Topeka, Kansas, United States

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Bardstown, Kentucky, United States

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Louisville, Kentucky, United States

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Haughton, Louisiana, United States

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Fall River, Massachusetts, United States

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Bingham Farms, Michigan, United States

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Jefferson City, Missouri, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Monroe, North Carolina, United States

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Cleveland, Ohio, United States

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Dayton, Ohio, United States

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Chickasha, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Gresham, Oregon, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Greenville, South Carolina, United States

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Simpsonville, South Carolina, United States

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Beaumont, Texas, United States

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Burleson, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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McAllen, Texas, United States

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Mesquite, Texas, United States

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Layton, Utah, United States

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Layton, Utah, United States

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Murray, Utah, United States

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Pleasant View, Utah, United States

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South Jordan, Utah, United States

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West Jordan, Utah, United States

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Richmond, Virginia, United States

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Brussels, Belgium

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Ghent, Belgium

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Gozée, Belgium

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Leuven, Belgium

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Liège, Belgium

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Cali, Colombia

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Medellín, Colombia

GSK Investigational Site

Jindřichův Hradec, Czechia

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Jindřichův Hradec, Czechia

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Jinočany, Czechia

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Ostrava, Czechia

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Prague, Czechia

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Santo Domingo, Dominican Republic

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Santo Domingo, Dominican Republic

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Santo Domingo Oeste, Dominican Republic

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Paide, Estonia

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Tartu, Estonia

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Acapulco, Mexico

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Hidalgo, Mexico

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Mexico City, Mexico

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Mexico City, Mexico

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Veracruz, Mexico

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Bydgoszcz, Poland

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Częstochowa, Poland

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Krakow, Poland

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Siemianowice Śląskie, Poland

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Torun, Poland

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Caguas, Puerto Rico

GSK Investigational Site

Ponce, Puerto Rico

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San Juan, Puerto Rico

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San Juan, Puerto Rico

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Bangkok, Thailand

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Rajathevee, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (97)