EUCTR2019-000607-33-IT进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 184
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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