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New chickenpox vaccine for toddlers shows promise in safety trial

NCT ID NCT06693895

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new chickenpox vaccine in 750 healthy children aged 12-15 months. Researchers will compare its safety to the existing Varivax vaccine. The goal is to see if the new vaccine causes similar side effects like injection site pain, fever, or rash.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
investigational varicella vaccine
What this could lead to
If successful, this could provide a safe and effective alternative chickenpox vaccine for young children.
What could go wrong
This is an early-stage safety study, so it may not prove the vaccine prevents chickenpox. Side effects like fever or rash are possible.

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 750 people

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

Started

Nov 2024

Expected to finish

Nov 2026

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 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 (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 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. * 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.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    37 sites in 8 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

    WITHDRAWN

    Phoenix, Arizona, 85006, United States

  • GSK Investigational Site

    WITHDRAWN

    Tucson, Arizona, 85741, United States

  • GSK Investigational Site

    RECRUITING

    Huntington Park, California, 90057, United States

  • GSK Investigational Site

    RECRUITING

    National City, California, 91950, United States

  • GSK Investigational Site

    RECRUITING

    West Covina, California, 91790, United States

  • GSK Investigational Site

    RECRUITING

    Hialeah, Florida, 33012, United States

  • GSK Investigational Site

    RECRUITING

    Miami, Florida, 33142, United States

  • GSK Investigational Site

    RECRUITING

    Chicago, Illinois, 60621, United States

  • GSK Investigational Site

    WITHDRAWN

    El Dorado, Kansas, 67042, United States

  • GSK Investigational Site

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • GSK Investigational Site

    RECRUITING

    Mankato, Minnesota, 56002, United States

  • GSK Investigational Site

    RECRUITING

    Lincoln, Nebraska, 68516, United States

  • GSK Investigational Site

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • GSK Investigational Site

    RECRUITING

    Dallas, Texas, 75230-2571, United States

  • GSK Investigational Site

    WITHDRAWN

    Dallas, Texas, 75235, United States

  • GSK Investigational Site

    RECRUITING

    Houston, Texas, 77065, United States

  • GSK Investigational Site

    RECRUITING

    Richmond, Texas, 77469, United States

  • GSK Investigational Site

    RECRUITING

    Richmond, Texas, 77469, United States

  • GSK Investigational Site

    WITHDRAWN

    San Antonio, Texas, 78244, United States

  • GSK Investigational Site

    COMPLETED

    Roy, Utah, 84067, United States

  • GSK Investigational Site

    RECRUITING

    Syracuse, Utah, 84075, United States

  • GSK Investigational Site

    RECRUITING

    Richmond, Virginia, 23294, United States

  • GSK Investigational Site

    WITHDRAWN

    Vienna, Virginia, 22180, United States

  • GSK Investigational Site

    WITHDRAWN

    Burgas, 8008, Bulgaria

  • GSK Investigational Site

    RECRUITING

    Gabrovo, 5300, Bulgaria

  • GSK Investigational Site

    RECRUITING

    Kyustendil, 2500, Bulgaria

  • GSK Investigational Site

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • GSK Investigational Site

    RECRUITING

    Rousse, 7000, Bulgaria

  • GSK Investigational Site

    RECRUITING

    Sevlievo, 5400, Bulgaria

  • GSK Investigational Site

    WITHDRAWN

    Yambol, 8600, Bulgaria

  • GSK Investigational Site

    RECRUITING

    Aarhus N, 8200, Denmark

  • GSK Investigational Site

    RECRUITING

    Copenhagen, DK-2100, Denmark

  • GSK Investigational Site

    RECRUITING

    Hvidovre, 2650, Denmark

  • GSK Investigational Site

    RECRUITING

    Odense C, DK-5000, Denmark

  • GSK Investigational Site

    RECRUITING

    Tallinn, 10615, Estonia

  • GSK Investigational Site

    RECRUITING

    Tallinn, 10617, Estonia

  • GSK Investigational Site

    RECRUITING

    Hong Kong, 00852, Hong Kong

  • GSK Investigational Site

    RECRUITING

    Shatin, Hong Kong

  • GSK Investigational Site

    RECRUITING

    Kaunas, 47116, Lithuania

  • GSK Investigational Site

    RECRUITING

    Kaunas, LT-48259, Lithuania

  • GSK Investigational Site

    RECRUITING

    Durango, 34000, Mexico

  • GSK Investigational Site

    RECRUITING

    Tlalpan, 14340, Mexico

  • GSK Investigational Site

    RECRUITING

    Tlalpan, 14340, Mexico

  • GSK Investigational Site

    RECRUITING

    Bydgoszcz, 85-796, Poland

  • GSK Investigational Site

    RECRUITING

    Trzebnica, 55-100, Poland

  • GSK Investigational Site

    RECRUITING

    Warsaw, 02-172, Poland

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