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Recruiting Phase 1, Phase 2 NCT04006808

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

Trial Parameters

Condition Herpes Zoster
Sponsor GlaxoSmithKline
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 184
Sex ALL
Min Age 1 Year
Max Age 17 Years
Start Date 2019-10-25
Completion 2026-05-01
Interventions
PED-HZ/su

Brief Summary

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant recipients aged 1-17 years

Eligibility Criteria

Inclusion Criteria: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol * Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure. * Written informed assent obtained from the subjects when applicable according to local requirements. * A male or female between, and including, 1 and 17 years of age at the time of randomisation (Visit Day 1) * Body weight ≥ 6 kg/13.23 pounds. * A subject is eligible if they meet at least one of the following criteria: * Documented previous VZV vaccination OR * Medically verified varicella (with source documentation) OR * Seropositive for VZV prior to transplantation. * Subjects with renal transplant more than six months (180 days) prior randomization (Visit Day 1) * Subject who has received an ABO compatible allogeneic renal transplant (allogra

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