Clinical trial Recruiting at 37 sites Phase 3 Interventional Ages 12 Months to 15 Months

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.

More Chickenpox trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages12 Months to 15 Months
SexAll
Enrollment750 (estimated)
SponsorGlaxoSmithKline
Industry-sponsored
Drugs / interventionsnirsevimab, immunotherapy, prednisone
Locations46 sites (Phoenix, Arizona and 45 other locations)
StatusRecruiting
StartedNovember 26, 2024
Main results expectedNovember 23, 2026
Study endsNovember 23, 2026
Registry record updatedMay 29, 2026
Trial IDNCT06693895 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

  • GSK Investigational Site
    Huntington Park, California, United States
    Recruiting
  • GSK Investigational Site
    National City, California, United States
    Recruiting
  • GSK Investigational Site
    West Covina, California, United States
    Recruiting
  • GSK Investigational Site
    Hialeah, Florida, United States
    Recruiting
  • GSK Investigational Site
    Miami, Florida, United States
    Recruiting
  • GSK Investigational Site
    Chicago, Illinois, United States
    Recruiting
Show 40 more locations
  • GSK Investigational Site
    Lafayette, Louisiana, United States
    Recruiting
  • GSK Investigational Site
    Mankato, Minnesota, United States
    Recruiting
  • GSK Investigational Site
    Lincoln, Nebraska, United States
    Recruiting
  • GSK Investigational Site
    Cincinnati, Ohio, United States
    Recruiting
  • GSK Investigational Site
    Dallas, Texas, United States
    Recruiting
  • GSK Investigational Site
    Houston, Texas, United States
    Recruiting
  • GSK Investigational Site
    Richmond, Texas, United States
    Recruiting
  • GSK Investigational Site
    Richmond, Texas, United States
    Recruiting
  • GSK Investigational Site
    Syracuse, Utah, United States
    Recruiting
  • GSK Investigational Site
    Richmond, Virginia, United States
    Recruiting
  • GSK Investigational Site
    Gabrovo, Bulgaria
    Recruiting
  • GSK Investigational Site
    Kyustendil, Bulgaria
    Recruiting
  • GSK Investigational Site
    Plovdiv, Bulgaria
    Recruiting
  • GSK Investigational Site
    Rousse, Bulgaria
    Recruiting
  • GSK Investigational Site
    Sevlievo, Bulgaria
    Recruiting
  • GSK Investigational Site
    Aarhus N, Denmark
    Recruiting
  • GSK Investigational Site
    Copenhagen, Denmark
    Recruiting
  • GSK Investigational Site
    Hvidovre, Denmark
    Recruiting
  • GSK Investigational Site
    Odense C, Denmark
    Recruiting
  • GSK Investigational Site
    Tallinn, Estonia
    Recruiting
  • GSK Investigational Site
    Tallinn, Estonia
    Recruiting
  • GSK Investigational Site
    Hong Kong, Hong Kong
    Recruiting
  • GSK Investigational Site
    Shatin, Hong Kong
    Recruiting
  • GSK Investigational Site
    Kaunas, Lithuania
    Recruiting
  • GSK Investigational Site
    Kaunas, Lithuania
    Recruiting
  • GSK Investigational Site
    Durango, Mexico
    Recruiting
  • GSK Investigational Site
    Tlalpan, Mexico
    Recruiting
  • GSK Investigational Site
    Tlalpan, Mexico
    Recruiting
  • GSK Investigational Site
    Bydgoszcz, Poland
    Recruiting
  • GSK Investigational Site
    Trzebnica, Poland
    Recruiting
  • GSK Investigational Site
    Warsaw, Poland
    Recruiting
  • GSK Investigational Site
    Phoenix, Arizona, United States
    Withdrawn
  • GSK Investigational Site
    Tucson, Arizona, United States
    Withdrawn
  • GSK Investigational Site
    El Dorado, Kansas, United States
    Withdrawn
  • GSK Investigational Site
    Dallas, Texas, United States
    Withdrawn
  • GSK Investigational Site
    San Antonio, Texas, United States
    Withdrawn
  • GSK Investigational Site
    Roy, Utah, United States
    Completed
  • GSK Investigational Site
    Vienna, Virginia, United States
    Withdrawn
  • GSK Investigational Site
    Burgas, Bulgaria
    Withdrawn
  • GSK Investigational Site
    Yambol, Bulgaria
    Withdrawn

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.