EUCTR2019-000607-33-GB进行中（未招募）1 期
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
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: 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
排除标准
- •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 (i.e. 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
- •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 (= 200 g/mol creatinine) believed to be of renal origin (an example of non-renal origin is proteinuria from mucus in a reconstructed bladder).
- •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
- •Atypical Haemolytic Uraemic Syndrome
- •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.
- •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 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
- •Administration or planned administration of a vaccine within 30 days prior to Visit Day 1 up to Visit Month 2 with the exception of an inactivated or subunit influenza vaccine which may be given 8 days prior to or 14 days after Visits Day 1 and 8 days prior to or 14 days after Visit Month 1.
- •Previous vaccination against HZ
- •Varicella vaccination within the 6 months (180 days) preceding Visit Day 1
- •Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine
- •Concurrent or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exp
研究者
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