Safety assessment of a new chickenpox vaccine for young children
Official title: A Phase 3a, Observer-blind, Randomized, Controlled Study to Evaluate the 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 · NCT06693895 · Data updated 2026-11-12
This study tests a new chickenpox vaccine in healthy kids aged 12 to 15 months to see if it's safe compared to the already approved vaccine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Months to 15 Months |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | nirsevimab, immunotherapy, prednisone |
| Locations | 46 sites (Phoenix, Arizona and 45 other locations) |
| Status | Recruiting |
| Started | November 26, 2024 |
| Main results expected | November 23, 2026 |
| Study ends | November 23, 2026 |
| Registry record updated | May 29, 2026 |
| Trial ID | NCT06693895 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 vaccine.
✕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 safety and tolerability of GSK's investigational varicella vaccine (VNS Vaccine) in healthy children aged 12 to 15 months. Participants will receive either the investigational vaccine or an already approved varicella vaccine (Varivax) to compare their safety profiles. The study aims to enroll children who have not previously contracted chickenpox or received any varicella vaccination. The findings will help determine if the new vaccine is a viable alternative to the existing one.
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 assessments, indicating a promising approach to evaluating new immunizations.
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 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.
Where it's running
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GSK Investigational Site
Huntington Park, California, United States Recruiting -
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National City, California, United States Recruiting -
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West Covina, California, United States Recruiting -
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Hialeah, Florida, United States Recruiting -
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Miami, Florida, United States Recruiting -
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Chicago, Illinois, United States Recruiting
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Mankato, Minnesota, United States Recruiting -
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Lincoln, Nebraska, United States Recruiting -
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Cincinnati, Ohio, United States Recruiting -
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Houston, Texas, United States Recruiting -
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Richmond, Texas, United States Recruiting -
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Syracuse, Utah, United States Recruiting -
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Gabrovo, Bulgaria Recruiting -
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Aarhus N, Denmark Recruiting -
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Copenhagen, Denmark Recruiting -
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Hvidovre, Denmark Recruiting -
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Odense C, Denmark Recruiting -
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Tallinn, Estonia Recruiting -
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Hong Kong, Hong Kong Recruiting -
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Shatin, Hong Kong Recruiting -
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Kaunas, Lithuania Recruiting -
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Durango, Mexico Recruiting -
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Tlalpan, Mexico Recruiting -
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Bydgoszcz, Poland Recruiting -
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Trzebnica, Poland Recruiting -
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Warsaw, Poland Recruiting -
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Phoenix, Arizona, United States Withdrawn -
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Tucson, Arizona, United States Withdrawn -
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El Dorado, Kansas, United States Withdrawn -
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Dallas, Texas, United States Withdrawn -
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San Antonio, Texas, United States Withdrawn -
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Roy, Utah, United States Completed -
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Vienna, Virginia, United States Withdrawn -
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Burgas, Bulgaria Withdrawn -
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Yambol, Bulgaria Withdrawn
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Immune response and safety of an investigational chickenpox vaccine and MMR given by muscle injection to healthy 12–15 month-olds
This trial will test whether GSK's investigational chickenpox vaccine given with MMR as a muscle shot is safe and produces a good immune response in healthy children aged 12 to 15 months, compared with Merck's chickenpox vaccine given under the skin.
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Second-dose chickenpox vaccine given three months after the first dose for 12–15 month olds
This test checks whether GSK’s investigational chickenpox vaccine is safe and produces a strong immune response as the second dose when given to healthy children three months after their first dose at age 12–15 months.
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Investigating a new chickenpox vaccine for healthy children aged 12 to 15 months
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.
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Second dose of chickenpox (varicella) vaccine for healthy children
This project will give a Sinovac second dose of the chickenpox vaccine to children aged 15 months–12 years who had a first dose at 12 months to see if switching brands is safe and produces good immune responses.
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Varicella vaccine with lower potencies in healthy children aged 12 months to 12 years
This test compares an investigational varicella vaccine called NBP608 with licensed vaccines in children aged 12 months to 12 years to see if it is safe and can provoke an immune response.
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MG1111 (BARYCELA) versus VARIVAX for preventing chickenpox in children 1 to 12 years
This will test whether the MG1111 (BARYCELA) vaccine is safe and produces an immune response comparable to VARIVAX in healthy children aged 12 months to 12 years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.