A study to test GlaxoSmithKline’s (GSK) candidate vaccine-GSK1437173A for prevention of shingles in children with kidney transplant

Phase 1

Conditions: Herpes Zoster Renal transplant Pediatric population
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2019-000607-33-ES

Lead Sponsor: GlaxoSmithKline S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 184

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)
•Subject who has received an ABO compatible allogeneic renal transplant (allograft).
•Subject with stable renal function with stability defined as <20% variability between the last two creatinine measurements or calculated glomerular filtration rate (GFR) or based on investigator opinion after review of multiple creatinine measurements or calculated GFRs.
•Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to randomization (Visit Day 1).
•Female subjects of childbearing potential may be enrolled in the study, if the subject
-has practiced adequate contraception for 30 days prior to Visit Day 1 and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
Are the trial subjects under 18? yes
Number of subjects for this age range: 184
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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
•Subjects without multiple dialysis options in the event acute or chronic dialysis needed.
•History of unstable or progressive neurological disorder.
•Subjects <= 5 years of age with a history of one or more simple or complex febrile seizures
•Subjects > 5 years with history of one or more complex febrile seizures
•Occurrence of a varicella or HZ episode by clinical history within the 6 months (180 days) preceding Visit Day 1
•Any autoimmune disease, with the following exceptions which do not constitute an exclusion criterion:
-IgA nephropathy
-Rapidly progressive glomerulonephritis
-Membranous glomerulonephritis
-Idiopathic Type I membranoproliferative glomerulonephritis
-Diabetes mellitus (type 1 and 2) with diabetic nephropathy
•Confirmed or suspected Human Immunodeficiency Virus or primary immunodeficiency disease
•Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
•Any condition which, in the judgement of the investigator would make intramuscular injection unsafe

Prior/Concomitant therapy
•Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before Visit Day 1 (Day -29 to Day -1), or planned use during the study period. Subjects on treatment for rejection with ongoing treatment with T-cell depleting Ab or IL2R Ab
•Use of anti-CD20 or other B-cell monoclonal antibody agents within 1 year of Visit Day 1 or planned administration during the duration of the study
•Administration of blood products prior to 3 months (90 days) of enrolment or planned administration during the duration of the study
•Administration of immunoglobulins prior to 6 months (180 days) of enrolment or planned administration of immunoglobulins during the duration of the study
•Administration or planned administration of a vaccine in the period starting 30 days before Visit Day 1 up to Visit Month 2
•Previous vaccination against HZ
•Varicella vaccination within the 6 months (180 days) preceding Visit Day 1

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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