New chickenpox vaccine for toddlers shows promise in safety trial
NCT ID NCT06693895
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 750 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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12 to 15 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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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Get notified about this study
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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.
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The places running it
37 sites in 8 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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GSK Investigational Site
WITHDRAWNPhoenix, Arizona, 85006, United States
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GSK Investigational Site
WITHDRAWNTucson, Arizona, 85741, United States
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GSK Investigational Site
RECRUITINGHuntington Park, California, 90057, United States
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GSK Investigational Site
RECRUITINGNational City, California, 91950, United States
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GSK Investigational Site
RECRUITINGWest Covina, California, 91790, United States
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GSK Investigational Site
RECRUITINGHialeah, Florida, 33012, United States
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GSK Investigational Site
RECRUITINGMiami, Florida, 33142, United States
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GSK Investigational Site
RECRUITINGChicago, Illinois, 60621, United States
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GSK Investigational Site
WITHDRAWNEl Dorado, Kansas, 67042, United States
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GSK Investigational Site
RECRUITINGLafayette, Louisiana, 70508, United States
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GSK Investigational Site
RECRUITINGMankato, Minnesota, 56002, United States
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GSK Investigational Site
RECRUITINGLincoln, Nebraska, 68516, United States
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GSK Investigational Site
RECRUITINGCincinnati, Ohio, 45245, United States
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GSK Investigational Site
RECRUITINGDallas, Texas, 75230-2571, United States
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GSK Investigational Site
WITHDRAWNDallas, Texas, 75235, United States
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GSK Investigational Site
RECRUITINGHouston, Texas, 77065, United States
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GSK Investigational Site
RECRUITINGRichmond, Texas, 77469, United States
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GSK Investigational Site
RECRUITINGRichmond, Texas, 77469, United States
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GSK Investigational Site
WITHDRAWNSan Antonio, Texas, 78244, United States
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GSK Investigational Site
COMPLETEDRoy, Utah, 84067, United States
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GSK Investigational Site
RECRUITINGSyracuse, Utah, 84075, United States
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GSK Investigational Site
RECRUITINGRichmond, Virginia, 23294, United States
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GSK Investigational Site
WITHDRAWNVienna, Virginia, 22180, United States
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GSK Investigational Site
WITHDRAWNBurgas, 8008, Bulgaria
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GSK Investigational Site
RECRUITINGGabrovo, 5300, Bulgaria
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GSK Investigational Site
RECRUITINGKyustendil, 2500, Bulgaria
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GSK Investigational Site
RECRUITINGPlovdiv, 4002, Bulgaria
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GSK Investigational Site
RECRUITINGRousse, 7000, Bulgaria
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GSK Investigational Site
RECRUITINGSevlievo, 5400, Bulgaria
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GSK Investigational Site
WITHDRAWNYambol, 8600, Bulgaria
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GSK Investigational Site
RECRUITINGAarhus N, 8200, Denmark
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GSK Investigational Site
RECRUITINGCopenhagen, DK-2100, Denmark
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GSK Investigational Site
RECRUITINGHvidovre, 2650, Denmark
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GSK Investigational Site
RECRUITINGOdense C, DK-5000, Denmark
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GSK Investigational Site
RECRUITINGTallinn, 10615, Estonia
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GSK Investigational Site
RECRUITINGTallinn, 10617, Estonia
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GSK Investigational Site
RECRUITINGHong Kong, 00852, Hong Kong
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GSK Investigational Site
RECRUITINGShatin, Hong Kong
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GSK Investigational Site
RECRUITINGKaunas, 47116, Lithuania
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GSK Investigational Site
RECRUITINGKaunas, LT-48259, Lithuania
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GSK Investigational Site
RECRUITINGDurango, 34000, Mexico
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GSK Investigational Site
RECRUITINGTlalpan, 14340, Mexico
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GSK Investigational Site
RECRUITINGTlalpan, 14340, Mexico
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GSK Investigational Site
RECRUITINGBydgoszcz, 85-796, Poland
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GSK Investigational Site
RECRUITINGTrzebnica, 55-100, Poland
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GSK Investigational Site
RECRUITINGWarsaw, 02-172, Poland
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