Study of GSKs PED-HZsu Vaccine for Preventing Shingles in Children Aged 1 to 17 Years Who Have Had Kidney Transplants

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.

A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant