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RecruitingAccepts healthy volunteersPhase 3

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 · NCT06740630

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 1–1 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 3
Target enrollment
1840
US sites recruiting
50
Study start
January 10, 2025
Record last updated
May 29, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Investigational varicella vaccine_Lot 1; Investigational varicella vaccine_Lot 2; Investigational varicella vaccine_Lot 3; Marketed varicella vaccine_Lot 1; Marketed varicella vaccine_Lot 2; MMR vaccine; Hepatitis A vaccine; PCV (pneumococcal conjugate vaccine) 13; PCV 20; Vaxneuvance

Conditions: Chickenpox

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • GSK Investigational Site

    Mobile, AL 36608

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Hot Springs, AR 71913

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Sherwood, AR 72120

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Canoga Park, CA 91304

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Covina, CA 91723

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Los Angeles, CA 90057

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Sacramento, CA 95823

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Ventura, CA 93003

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Walnut Creek, CA 94598

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Winnetka, CA 91306

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami, FL 33184

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Miami Lakes, FL 33014

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Spring Hill, FL 34609

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Tampa, FL 33613

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Covington, GA 70433

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Ammon, ID 83406

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Moline, IL 61265

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    South Bend, IN 46617

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Topeka, KS 66606

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Bardstown, KY 40004

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Louisville, KY 40202-1822

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Haughton, LA 71037

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Fall River, MA 02721-1735

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Bingham Farms, MI 48025

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Jefferson City, MO 65109

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Lincoln, NE 68505

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Lincoln, NE 68516

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    The Bronx, NY 10456

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Charlotte, NC 28203

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Cleveland, OH 44121

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Dayton, OH 45424

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Chickasha, OK 73018

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Tulsa, OK 74137

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Gresham, OR 97030

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Charleston, SC 29407

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Charleston, SC 29414

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Greenville, SC 29607

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Simpsonville, SC 29681

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Beaumont, TX 77701

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Corpus Christi, TX 78404

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Dallas, TX 75230-2571

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Houston, TX 77030

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Houston, TX 77087

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    McAllen, TX 78504

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Mesquite, TX 75149

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Layton, UT 84041

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Murray, UT 84107

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Pleasant View, UT 84404

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    South Jordan, UT 84095

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

  • GSK Investigational Site

    Richmond, VA 23226

    Site contact: US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com

Study contacts (from the official record)

  • US GSK Clinical Trials Call Center · 877-379-3718 · GSKClinicalSupportHD@gsk.com
  • EU GSK Clinical Trials Call Center · +44 (0) 20 89904466 · GSKClinicalSupportHD@gsk.com
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A Study on the Immune Response and Safety of an Investigational… (NCT06740630) | Bored Studies