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New Needle-Freeze? muscle shot chickenpox vaccine tested in toddlers

NCT ID NCT06855160

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 given as a muscle injection in healthy children aged 12 to 15 months. It compares the immune response and safety of this vaccine to the standard shot given under the skin. The study also looks at combining it with the MMR vaccine. About 911 children will take part.

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 911 people

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

Started

Apr 2025

Expected to finish

Feb 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 the administration of study intervention. Exclusion Criteria: * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Hypersensitivity to latex. * Major congenital defects, as assessed by the investigator. * Recurrent history of uncontrolled neurological disorders or seizures. * History of measles, mumps, rubella, or varicella disease. * Active untreated tuberculosis. * Participants with bleeding disorders (e.g., thrombocytopenia or any coagulation disorder). * Condition that in the judgment of the investigator would make intramuscular injection unsafe. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior/Concomitant therapy * 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. * 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 varicella virus. * Previous vaccination against hepatitis A 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. Prior/Concurrent clinical study experience • 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). Other exclusion criteria * Any study personnel or their immediate dependents, family, or household members. * Child in care. * 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 \<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

    21 sites in 7 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

    Tucson, Arizona, 85704, United States

  • GSK Investigational Site

    RECRUITING

    Huntington Park, California, 90255, United States

  • GSK Investigational Site

    RECRUITING

    Sherman Oaks, California, 91403, United States

  • GSK Investigational Site

    RECRUITING

    Coral Gables, Florida, 33134, United States

  • GSK Investigational Site

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • GSK Investigational Site

    RECRUITING

    Tampa, Florida, 33612, United States

  • GSK Investigational Site

    RECRUITING

    Idaho Falls, Idaho, 83404, United States

  • GSK Investigational Site

    RECRUITING

    Dayton, Ohio, 45414, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77584, United States

  • GSK Investigational Site

    RECRUITING

    Lewisville, Texas, 75067, United States

  • GSK Investigational Site

    RECRUITING

    Mansfield, Texas, 76063, United States

  • GSK Investigational Site

    RECRUITING

    Pharr, Texas, 78577, United States

  • GSK Investigational Site

    RECRUITING

    Richmond, Virginia, 23294, United States

  • GSK Investigational Site

    RECRUITING

    Alken, 3570, Belgium

  • GSK Investigational Site

    RECRUITING

    Tartu, 50106, Estonia

  • GSK Investigational Site

    WITHDRAWN

    Athens, 115 27, Greece

  • GSK Investigational Site

    RECRUITING

    Athens, 11527, Greece

  • GSK Investigational Site

    RECRUITING

    Thessaloniki, 54642, Greece

  • GSK Investigational Site

    RECRUITING

    Trzebnica, 55-100, Poland

  • GSK Investigational Site

    RECRUITING

    Brasov, 500283, Romania

  • GSK Investigational Site

    RECRUITING

    Calarasi, 910160, Romania

  • GSK Investigational Site

    RECRUITING

    Chiang Mai, 50200, Thailand

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