Clinical trial Recruiting at 87 sites Phase 3 Interventional Ages 12 Months to 15 Months

Investigating a new chickenpox vaccine for healthy children aged 12 to 15 months

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

Run by GlaxoSmithKline · NCT06740630 · Data updated 2026-11-12

This study is testing a new chickenpox vaccine in healthy kids aged 12 to 15 months to see if it works well and is safe compared to an existing vaccine.

More Chickenpox trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages12 Months to 15 Months
SexAll
Enrollment1840 (estimated)
SponsorGlaxoSmithKline
Industry-sponsored
Drugs / interventionsnirsevimab, immunotherapy, prednisone
Locations97 sites (Mobile, Alabama and 96 other locations)
StatusRecruiting
StartedJanuary 10, 2025
Main results expectedDecember 25, 2026
Study endsMay 17, 2027
Registry record updatedMay 29, 2026
Trial IDNCT06740630 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are healthy children aged 12 to 15 months who have not had chickenpox or received a varicella vaccination.

Probably not a fit

Patients who have previously contracted chickenpox or received a varicella vaccination will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the immune response and safety of an investigational chickenpox vaccine in healthy children aged 12 to 15 months. It compares the immune response of three different lots of the new vaccine to an already approved vaccine known as Varivax. Participants must not have previously contracted chickenpox or received any varicella vaccination. The study aims to ensure that the new vaccine is both effective and safe for this age group.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective chickenpox vaccination option for young children.

How similar studies have gone: Other studies have shown success with similar vaccine approaches, indicating a promising avenue for this investigational vaccine.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • GSK Investigational Site
    Mobile, Alabama, United States
    Recruiting
  • GSK Investigational Site
    Hot Springs, Arkansas, United States
    Recruiting
  • GSK Investigational Site
    Sherwood, Arkansas, United States
    Recruiting
  • GSK Investigational Site
    Canoga Park, California, United States
    Recruiting
  • GSK Investigational Site
    Covina, California, United States
    Recruiting
  • GSK Investigational Site
    Los Angeles, California, United States
    Recruiting
Show 44 more locations
  • GSK Investigational Site
    Sacramento, California, United States
    Recruiting
  • GSK Investigational Site
    Ventura, California, United States
    Recruiting
  • GSK Investigational Site
    Walnut Creek, California, United States
    Recruiting
  • GSK Investigational Site
    Winnetka, California, United States
    Recruiting
  • GSK Investigational Site
    Miami, Florida, United States
    Recruiting
  • GSK Investigational Site
    Miami Lakes, Florida, United States
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  • GSK Investigational Site
    Spring Hill, Florida, United States
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  • GSK Investigational Site
    Tampa, Florida, United States
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  • GSK Investigational Site
    Covington, Georgia, United States
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  • GSK Investigational Site
    Ammon, Idaho, United States
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  • GSK Investigational Site
    Moline, Illinois, United States
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  • GSK Investigational Site
    South Bend, Indiana, United States
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  • GSK Investigational Site
    Topeka, Kansas, United States
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  • GSK Investigational Site
    Bardstown, Kentucky, United States
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  • GSK Investigational Site
    Louisville, Kentucky, United States
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  • GSK Investigational Site
    Haughton, Louisiana, United States
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  • GSK Investigational Site
    Fall River, Massachusetts, United States
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  • GSK Investigational Site
    Bingham Farms, Michigan, United States
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  • GSK Investigational Site
    Jefferson City, Missouri, United States
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  • GSK Investigational Site
    Lincoln, Nebraska, United States
    Recruiting
  • GSK Investigational Site
    Lincoln, Nebraska, United States
    Recruiting
  • GSK Investigational Site
    The Bronx, New York, United States
    Recruiting
  • GSK Investigational Site
    Charlotte, North Carolina, United States
    Recruiting
  • GSK Investigational Site
    Cleveland, Ohio, United States
    Recruiting
  • GSK Investigational Site
    Dayton, Ohio, United States
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  • GSK Investigational Site
    Chickasha, Oklahoma, United States
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  • GSK Investigational Site
    Tulsa, Oklahoma, United States
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  • GSK Investigational Site
    Gresham, Oregon, United States
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  • GSK Investigational Site
    Charleston, South Carolina, United States
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  • GSK Investigational Site
    Charleston, South Carolina, United States
    Recruiting
  • GSK Investigational Site
    Greenville, South Carolina, United States
    Recruiting
  • GSK Investigational Site
    Simpsonville, South Carolina, United States
    Recruiting
  • GSK Investigational Site
    Beaumont, Texas, United States
    Recruiting
  • GSK Investigational Site
    Corpus Christi, Texas, United States
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  • GSK Investigational Site
    Dallas, Texas, United States
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  • GSK Investigational Site
    Houston, Texas, United States
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  • GSK Investigational Site
    Houston, Texas, United States
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  • GSK Investigational Site
    McAllen, Texas, United States
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  • GSK Investigational Site
    Mesquite, Texas, United States
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  • GSK Investigational Site
    Layton, Utah, United States
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  • GSK Investigational Site
    Murray, Utah, United States
    Recruiting
  • GSK Investigational Site
    Pleasant View, Utah, United States
    Recruiting
  • GSK Investigational Site
    South Jordan, Utah, United States
    Recruiting
  • GSK Investigational Site
    Richmond, Virginia, United States
    Recruiting

+47 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.