EUCTR2019-000607-33-IT
Active, not recruiting
Phase 1
A Phase II, randomised, 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
- Herpes Zoster Renal transplant Pediatric population
- 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
- •Medical conditions:
- •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).
- •Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment.
- •PRA or cPRA or cRF score that is unknown at the time of transplant.
- •VZV serostatus unknown prior to transplant.
- •Subjects with advanced chronic kidney disease (CKD) (that is, estimated GFR by the bedside CKD in children equation of less than 30 mL/min/1\.73 m2\).
- •Evidence of significant proteinuria (major and equal to 200 g/mol creatinine) believed to be of renal origin (an example of non\-renal origin is proteinuria from mucus in a reconstructed bladder).
Outcomes
Primary Outcomes
Not specified
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