Actively Recruiting
Reactogenicity, Safety and Immune Response Study of GSKs Pediatric Herpes Zoster Vaccine in Kidney Transplant Children
Led by GlaxoSmithKline · Updated on 2026-02-27
184
Participants Needed
31
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the reactogenicity, safety, and immune response of two doses of PED-HZsu, GlaxoSmithKlines vaccine candidate, for preventing Herpes Zoster in immunocompromised children aged 1 to 17 years who have had a kidney transplant. This Phase 12 study focuses on pediatric renal transplant recipients to understand how the vaccine performs in this vulnerable group. Participants are divided by age and treatment into four groups children aged 12 to 17 receiving the vaccine, similar-aged children receiving standard care without the vaccine, children aged 1 to 11 receiving the vaccine, and the youngest group receiving standard care. Vaccinated groups receive two intramuscular doses of PED-HZsu in the deltoid muscle on day 1 and one month later. The younger age group enrollment is staggered, starting after safety data from the older group is reviewed. During the study, participants are monitored closely for local and general adverse events within seven days after each vaccination, as well as unsolicited adverse events and serious safety concerns up to two months post-vaccination. Researchers measure antibody levels one month after the second dose to assess immune response. Follow-up continues up to 13 months to track serious events, kidney transplant rejection, and occurrence of Herpes Zoster. The study includes careful assessment of seizures and other potential side effects related to the vaccine.
CONDITIONS
Brief Title
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal representative able and willing to comply with study requirements
- Written informed consent from parent/legal representative before study procedures
- Written informed assent from child when applicable
- Male or female aged 1 to 17 years at randomization
- Body weight of at least 6 kg
- Documented previous varicella vaccination, medically verified varicella infection, or positive varicella antibody before transplant
- Kidney transplant received more than six months before randomization
- ABO compatible allogeneic renal transplant
- Stable kidney function with less than 20% variability in creatinine levels or investigator opinion
- Receiving maintenance immunosuppressive therapy for at least one month before randomization
- Female of childbearing potential must use adequate contraception 30 days before and during treatment and for 2 months after vaccination series
You will not qualify if you...
- Primary kidney disease with high risk of recurrence in transplant
- Evidence of recurrent primary kidney disease in current transplant
- Previous transplant loss due to recurrent disease
- History of more than one organ transplant
- Acute transplant rejection episode within six months before enrollment
- Unknown panel reactive antibody score at transplant
- Unknown varicella antibody status before transplant
- Advanced chronic kidney disease
- Significant proteinuria believed renal in origin (≥ 200 g/mol creatinine)
- Lack of multiple dialysis options if needed
- History of unstable or progressive neurological disorder
- History of febrile seizures depending on age
- Varicella or Herpes Zoster episode within six months before enrollment
- Autoimmune diseases except specific listed nephropathies and diabetes with nephropathy
- Confirmed or suspected HIV or primary immunodeficiency
- Any condition increasing risk per investigator
- History of hypersensitivity to vaccine components
- Conditions making intramuscular injection unsafe
- Atypical Hemolytic Uremic Syndrome
- Use of investigational products or treatments for rejection recently or planned
- Use of certain monoclonal antibodies within one year
- Recent or planned blood product or immunoglobulin administration
- Recent vaccinations except certain influenza vaccines
- Previous Herpes Zoster vaccination
- Planned Herpes Zoster or varicella vaccine during study
- Participation in other clinical studies involving investigational or non-registered products
- Child in care
- Pregnant or breastfeeding female
- Planning pregnancy or stopping contraception during study period
- Evidence or suspicion of non-compliance with immunosuppressive therapies
- Failure to complete pre-vaccination diary card
- Study personnel or immediate family members
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
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