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New chickenpox vaccine shows promise in toddler trial

NCT ID NCT06740630

Vaccine Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new chickenpox vaccine in healthy children aged 12 to 15 months who have never had chickenpox or the vaccine. Researchers want to see if the new vaccine works as well as the approved Varivax vaccine and if different batches of the new vaccine produce consistent immune responses. About 1,840 children will take part, and the study is currently recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,840 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 15 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chickenpox prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chickenpox

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • GSK Investigational Site

    RECRUITING

    Mobile, Alabama, 36608, United States

  • GSK Investigational Site

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • GSK Investigational Site

    RECRUITING

    Sherwood, Arkansas, 72120, United States

  • GSK Investigational Site

    RECRUITING

    Canoga Park, California, 91304, United States

  • GSK Investigational Site

    RECRUITING

    Covina, California, 91723, United States

  • GSK Investigational Site

    WITHDRAWN

    Fullerton, California, 92835, United States

  • GSK Investigational Site

    WITHDRAWN

    Long Beach, California, 90807, United States

  • GSK Investigational Site

    RECRUITING

    Los Angeles, California, 90057, United States

  • GSK Investigational Site

    WITHDRAWN

    Paramount, California, 90723, United States

  • GSK Investigational Site

    RECRUITING

    Sacramento, California, 95823, United States

  • GSK Investigational Site

    RECRUITING

    Ventura, California, 93003, United States

  • GSK Investigational Site

    RECRUITING

    Walnut Creek, California, 94598, United States

  • GSK Investigational Site

    RECRUITING

    Winnetka, California, 91306, United States

  • GSK Investigational Site

    WITHDRAWN

    Miami, Florida, 33176, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33184, United States

  • GSK Investigational Site

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • GSK Investigational Site

    RECRUITING

    Spring Hill, Florida, 34609, United States

  • GSK Investigational Site

    RECRUITING

    Tampa, Florida, 33613, United States

  • GSK Investigational Site

    RECRUITING

    Covington, Georgia, 70433, United States

  • GSK Investigational Site

    RECRUITING

    Ammon, Idaho, 83406, United States

  • GSK Investigational Site

    RECRUITING

    Moline, Illinois, 61265, United States

  • GSK Investigational Site

    RECRUITING

    South Bend, Indiana, 46617, United States

  • GSK Investigational Site

    RECRUITING

    Topeka, Kansas, 66606, United States

  • GSK Investigational Site

    RECRUITING

    Bardstown, Kentucky, 40004, United States

  • GSK Investigational Site

    RECRUITING

    Louisville, Kentucky, 40202-1822, United States

  • GSK Investigational Site

    RECRUITING

    Haughton, Louisiana, 71037, United States

  • GSK Investigational Site

    RECRUITING

    Fall River, Massachusetts, 02721-1735, United States

  • GSK Investigational Site

    RECRUITING

    Bingham Farms, Michigan, 48025, United States

  • GSK Investigational Site

    RECRUITING

    Jefferson City, Missouri, 65109, United States

  • GSK Investigational Site

    RECRUITING

    Lincoln, Nebraska, 68505, United States

  • GSK Investigational Site

    WITHDRAWN

    Lincoln, Nebraska, 68510, United States

  • GSK Investigational Site

    RECRUITING

    Lincoln, Nebraska, 68516, United States

  • GSK Investigational Site

    RECRUITING

    The Bronx, New York, 10456, United States

  • GSK Investigational Site

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • GSK Investigational Site

    WITHDRAWN

    Monroe, North Carolina, 28112, United States

  • GSK Investigational Site

    RECRUITING

    Cleveland, Ohio, 44121, United States

  • GSK Investigational Site

    RECRUITING

    Dayton, Ohio, 45424, United States

  • GSK Investigational Site

    RECRUITING

    Chickasha, Oklahoma, 73018, United States

  • GSK Investigational Site

    RECRUITING

    Tulsa, Oklahoma, 74137, United States

  • GSK Investigational Site

    RECRUITING

    Gresham, Oregon, 97030, United States

  • GSK Investigational Site

    RECRUITING

    Charleston, South Carolina, 29407, United States

  • GSK Investigational Site

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • GSK Investigational Site

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • GSK Investigational Site

    RECRUITING

    Simpsonville, South Carolina, 29681, United States

  • GSK Investigational Site

    RECRUITING

    Beaumont, Texas, 77701, United States

  • GSK Investigational Site

    WITHDRAWN

    Burleson, Texas, 76028, United States

  • GSK Investigational Site

    RECRUITING

    Corpus Christi, Texas, 78404, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75230-2571, United States

  • GSK Investigational Site

    WITHDRAWN

    Dallas, Texas, 75251, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77030, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77087, United States

  • GSK Investigational Site

    RECRUITING

    McAllen, Texas, 78504, United States

  • GSK Investigational Site

    RECRUITING

    Mesquite, Texas, 75149, United States

  • GSK Investigational Site

    RECRUITING

    Layton, Utah, 84041, United States

  • GSK Investigational Site

    COMPLETED

    Layton, Utah, 84041, United States

  • GSK Investigational Site

    RECRUITING

    Murray, Utah, 84107, United States

  • GSK Investigational Site

    RECRUITING

    Pleasant View, Utah, 84404, United States

  • GSK Investigational Site

    RECRUITING

    South Jordan, Utah, 84095, United States

  • GSK Investigational Site

    WITHDRAWN

    West Jordan, Utah, 84088, United States

  • GSK Investigational Site

    RECRUITING

    Richmond, Virginia, 23226, United States

  • GSK Investigational Site

    RECRUITING

    Brussels, 1200, Belgium

  • GSK Investigational Site

    RECRUITING

    Ghent, 9000, Belgium

  • GSK Investigational Site

    RECRUITING

    Gozée, 6534, Belgium

  • GSK Investigational Site

    RECRUITING

    Leuven, 3000, Belgium

  • GSK Investigational Site

    RECRUITING

    Liège, 4000, Belgium

  • GSK Investigational Site

    RECRUITING

    Cali, 760042, Colombia

  • GSK Investigational Site

    RECRUITING

    Medellín, 050021, Colombia

  • GSK Investigational Site

    RECRUITING

    Jindřichův Hradec, 377 01, Czechia

  • GSK Investigational Site

    RECRUITING

    Jindřichův Hradec, 37701, Czechia

  • GSK Investigational Site

    RECRUITING

    Jinočany, 530 12, Czechia

  • GSK Investigational Site

    RECRUITING

    Ostrava, 708 00, Czechia

  • GSK Investigational Site

    RECRUITING

    Prague, 160 00, Czechia

  • GSK Investigational Site

    RECRUITING

    Santo Domingo, 10201, Dominican Republic

  • GSK Investigational Site

    RECRUITING

    Santo Domingo, 10205, Dominican Republic

  • GSK Investigational Site

    RECRUITING

    Santo Domingo Oeste, 11114, Dominican Republic

  • GSK Investigational Site

    RECRUITING

    Paide, 72713, Estonia

  • GSK Investigational Site

    RECRUITING

    Tartu, 50106, Estonia

  • GSK Investigational Site

    RECRUITING

    Acapulco, 39670, Mexico

  • GSK Investigational Site

    RECRUITING

    Hidalgo, 42000, Mexico

  • GSK Investigational Site

    RECRUITING

    Mexico City, 6750, Mexico

  • GSK Investigational Site

    RECRUITING

    Mexico City, Mexico

  • GSK Investigational Site

    RECRUITING

    Veracruz, 91900, Mexico

  • GSK Investigational Site

    RECRUITING

    Bydgoszcz, 85-048, Poland

  • GSK Investigational Site

    RECRUITING

    Częstochowa, 42-217, Poland

  • GSK Investigational Site

    RECRUITING

    Krakow, 30-363, Poland

  • GSK Investigational Site

    RECRUITING

    Siemianowice Śląskie, 41103, Poland

  • GSK Investigational Site

    RECRUITING

    Torun, 87-100, Poland

  • GSK Investigational Site

    RECRUITING

    Caguas, 00725, Puerto Rico

  • GSK Investigational Site

    RECRUITING

    Ponce, 00716, Puerto Rico

  • GSK Investigational Site

    RECRUITING

    San Juan, 00918, Puerto Rico

  • GSK Investigational Site

    RECRUITING

    San Juan, 907, Puerto Rico

  • GSK Investigational Site

    RECRUITING

    Bangkok, 10700, Thailand

  • GSK Investigational Site

    RECRUITING

    Rajathevee, 10400, Thailand

  • GSK Investigational Site

    RECRUITING

    Abu Dhabi, United Arab Emirates

  • GSK Investigational Site

    RECRUITING

    Abu Dhabi, United Arab Emirates

  • GSK Investigational Site

    RECRUITING

    Abu Dhabi, United Arab Emirates

  • GSK Investigational Site

    RECRUITING

    Al Ain City, United Arab Emirates

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Other studies related to the condition(s) this trial covers.