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

Last updated: January 17, 2025
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Shingles

Rash

Treatment

Investigational varicella vaccine

PCV (pneumococcal conjugate vaccine) 13

Measles, mumps, and rubella vaccine

Clinical Study ID

NCT06693895
213997
2024-515868-31-00
  • Ages 12-15
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion

Inclusion Criteria:

  • Participant's parent(s)/Legally acceptable representatives (LAR[s]), who, in theopinion of the investigator, can and will comply with the requirements of theprotocol (e.g., completion of the eDiaries, return for follow-up visits).

  • Written or witnessed/thumb printed informed consent obtained from the participant'sparent(s)/LAR(s) prior to performance of any study-specific procedure.

  • Healthy participants as established by medical history and clinical examinationbefore entering the study.

  • A male or female between, and including, 12 to 15 months of age (i.e., from the dayof 1 year birthday until the day before 16 months of age) at the time of theadministration of study interventions.

  • Only for children in countries where PCV is recommended at 12 to 15 months of age asper national immunization schedule and provided as part of the study interventions:participant who previously received the primary series of PCV in the first year oflife with last dose at least 60 days prior to study entry.

Exclusion

Exclusion Criteria:

  • History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study interventions.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical 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 poseadditional risk to the participant due to participation in the study.

  • Use of any investigational or non-registered product (drug, vaccine or invasivemedical device) other than the study interventions during the period beginning 30days before the dose of study interventions administration (Day -29 to Day 1), ortheir planned use during the study period.

  • Planned administration of a vaccine in the period starting 30 days before the doseand 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 timeduring the study and administered at a different location than the studyinterventions. Any other age-appropriate vaccine may be given starting at Visit 2and anytime thereafter.

  • Chronic administration of immune-modifying drugs (defined as more than 14consecutive days in total) and/or planned use of long-acting immune modifyingtreatments 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/daywith maximum of 20 mg/day for pediatric participants. Inhaled and topicalsteroids are allowed.

  • Administration of immunoglobulins and/or any blood products or plasmaderivatives.

  • Up to 180 days prior to study interventions administration: long acting immunemodifying drugs including among others immunotherapy (e.g., tumor necrosisfactor-inhibitors), monoclonal antibodies (except the ones not interfering withthe immune response to the study vaccines, e.g., nirsevimab), antitumoralmedication.

  • 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 asper 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 studyperiod, in which the participant has been or will be exposed to an investigationalor 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.

Study Design

Total Participants: 750
Treatment Group(s): 7
Primary Treatment: Investigational varicella vaccine
Phase: 3
Study Start date:
November 26, 2024
Estimated Completion Date:
November 23, 2026

Connect with a study center

  • GSK Investigational Site

    Burgas, 8008
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Kyustendil, 2500
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Ruse, 7000
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Sevlievo, 5400
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Yambol, 8600
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Aarhus N, 8200
    Denmark

    Site Not Available

  • GSK Investigational Site

    Copenhagen, DK-2100
    Denmark

    Site Not Available

  • GSK Investigational Site

    Hvidovre, 2650
    Denmark

    Site Not Available

  • GSK Investigational Site

    Odense C, DK-5000
    Denmark

    Site Not Available

  • GSK Investigational Site

    Tallinn, 10615
    Estonia

    Site Not Available

  • GSK Investigational Site

    Hong Kong, 00852
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Shatin,
    Hong Kong

    Site Not Available

  • GSK Investigational Site

    Kaunas, 47116
    Lithuania

    Site Not Available

  • GSK Investigational Site

    Durango, 34000
    Mexico

    Site Not Available

  • GSK Investigational Site

    Tlalpan, 14340
    Mexico

    Site Not Available

  • GSK Investigational Site

    Bydgoszcz, 85-796
    Poland

    Site Not Available

  • GSK Investigational Site

    Trzebnica, 55-100
    Poland

    Site Not Available

  • GSK Investigational Site

    Warszawa, 02-172
    Poland

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • GSK Investigational Site

    Tucson, Arizona 85741
    United States

    Site Not Available

  • GSK Investigational Site

    Huntington Park, California 90255
    United States

    Site Not Available

  • GSK Investigational Site

    National City, California 91950
    United States

    Site Not Available

  • GSK Investigational Site

    West Covina, California 91790
    United States

    Active - Recruiting

  • GSK Investigational Site

    Hialeah, Florida 33012
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33134
    United States

    Site Not Available

  • GSK Investigational Site

    Chicago, Illinois 60621
    United States

    Site Not Available

  • GSK Investigational Site

    El Dorado, Kansas 67042
    United States

    Site Not Available

  • GSK Investigational Site

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • GSK Investigational Site

    Mankato, Minnesota 56002
    United States

    Site Not Available

  • GSK Investigational Site

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45245
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75235
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77065
    United States

    Site Not Available

  • GSK Investigational Site

    Richmond, Texas 77469
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78244
    United States

    Site Not Available

  • GSK Investigational Site

    Syracuse, Utah 84075
    United States

    Site Not Available

  • GSK Investigational Site

    Vienna, Virginia 22180
    United States

    Site Not Available

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