A study to test GlaxoSmithKline's (GSK) candidate vaccine-GSK1437173A for prevention of shingles in children with kidney transplant.
- Conditions
- Herpes Zoster Renal transplant Pediatric populationMedDRA version: 20.1Level: LLTClassification code 10040555Term: ShinglesSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2019-000607-33-IT
- Lead Sponsor
- GLAXOSMITHKLINE BIOLOGICALS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 184
• 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)
• 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 based on investigator opinion after review of multiple creatinine measurements.
• 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:
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
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).
• Atypical Haemolytic Uraemic Syndrome.
• Subjects without multiple dialysis options (that is peritoneal and/or more than one anatomical access site for haemodialysis) 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 > 5years 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 (MPGN)
- Diabetes mellitus (type 1 and 2) with diabetic nephropathy
- Confirmed or suspected HIV 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 (IM) injection unsafe.
• Atypical Haemolytic Uraemic Syndrome.
Prior/Concomitant therapy:
• Use of any investigational or non-registered product‡ (drug, vaccine or medical device) 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.
• Subject in receipt of treatment for rejection during the six months (180 days) prior to enrolment.
• Use of anti-CD20 or other B-cell monoclonal antibody agents (For example, rituximab) within 1 year of Visit Day 1 or planned administration during the duration of the study.
• Administration of blood products 3 months (90 days) prior to Visit Day 1 or planned administration during the duration of the study.
• Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or planned administration of immunoglobulins during the duration of the study.
For further exclusion criteria please refer to the protocol.
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