EUCTR2019-000607-33-FR
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
- Herpes Zoster Renal transplant Pediatric population
- Sponsor
- GlaxoSmithKline Biologicals
- Enrollment
- 184
- Status
- Active, not recruiting
- Last Updated
- 6 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 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
- •Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment or receipt of treatment for rejection during 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
Outcomes
Primary Outcomes
Not specified
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