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