EUCTR2019-000607-33-GB
Active, not recruiting
Phase 1
A Phase II, randomized, open-label, multicentre study to assess the reactogenicity, safety and immunogenicity of GSK’s paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su) when administered intramuscularly on a two-dose schedule to immunocompromised paediatric renal transplant recipients from 1 to 17 years of age. - ZOSTER-047
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 184
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
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\)
Exclusion Criteria
- •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 (i.e. kidney\-liver, simultaneous double kidney or kidney\-other organ(s) transplanted).
- •Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment
- •Panel Reactive Antibodies (PRA) calculated PRA (cPRA) or Calculated Reaction Frequency (cRF) score that is unknown at the time of transplant
- •VZV serostatus unknown prior to transplant
- •Subjects with advanced chronic kidney disease
- •Evidence of significant proteinuria (\= 200 g/mol creatinine) believed to be of renal origin (an example of non\-renal origin is proteinuria from mucus in a reconstructed bladder).
- •Subjects without multiple dialysis options in the event acute or chronic dialysis needed.
Outcomes
Primary Outcomes
Not specified
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