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

ConditionHerpes Zoster
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-17
SponsorGlaxoSmithKline

About this trial

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

Qualifiers

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)

Disqualifiers

Any primary kidney disease with a high incidence of recurrent primary kidney disease within the allograft

Evidence of recurrent primary kidney disease within the current allograft

Previous allograft loss secondary to recurrent primary kidney disease

History of more than one organ transplanted (that is, kidney-liver, simultaneous double kidney or kidney-other organ(s) transplanted).

Trial design

Treatments tested in this trial

  • PED-HZ/su

Treatment groups

184 Participants
are divided into 4 treatment groups

Sponsors and collaborators