Investigating a new chickenpox vaccine for healthy children aged 12 to 15 months

A Phase 3a, Observer-blind, Randomized, Controlled Study to Demonstrate Lot-to-lot Consistency and Evaluate the Immunogenicity and Safety of an Investigational Varicella Vaccine Compared With Varivax, Administered as a First Dose to Healthy Children 12 to 15 Months of Age

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.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1840 (estimated)
• Ages: 12 Months to 15 Months
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Drugs / interventions: nirsevimab, immunotherapy, prednisone
• Locations: 5 sites (Tampa, Florida and 4 other locations)
• Trial ID: NCT06740630 on ClinicalTrials.gov

What this trial studies

This study evaluates the immune response and safety of an investigational chickenpox vaccine in healthy children aged 12 to 15 months. It compares the immune response of three different lots of the new vaccine to an already approved vaccine known as Varivax. Participants must not have previously contracted chickenpox or received any varicella vaccination. The study aims to ensure that the new vaccine is both effective and safe for this age group.

Who should consider this trial

Good fit: Ideal candidates are healthy children aged 12 to 15 months who have not had chickenpox or received a varicella vaccination.

Not a fit: Patients who have previously contracted chickenpox or received a varicella vaccination will not benefit from this study.

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 performed: Other studies have shown success with similar vaccine approaches, indicating a promising avenue for this investigational vaccine.

Eligibility 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 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 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.
* Hypersensitivity to latex.
* Major congenital defects, as assessed by the investigator.
* 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.

\*If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is organized by public health authorities outside the routine immunization program, the time period described above can be reduced provided it is used according to the local governmental recommendations and sponsor is notified

* 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 this trial is running

Tampa, Florida and 4 other locations

• GSK Investigational Site — Tampa, Florida, United States (Recruiting)
• GSK Investigational Site — Bingham Farms, Michigan, United States (Recruiting)
• GSK Investigational Site — McAllen, Texas, United States (Recruiting)
• GSK Investigational Site — Layton, Utah, United States (Recruiting)
• GSK Investigational Site — Layton, Utah, United States (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Chickenpox; Chicken pox; VNS; Varicella; Varivax; Healthy Children