A reactogenicity, safety and immunogenicity study of GSK's paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su) GSK143713A in immunocompromised paediatric renal transplant recipients - 200075

GlaxoSmithKline Biologicals0 个研究点目标入组 191 人开始时间: 2023年1月27日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: GlaxoSmithKline Biologicals
入组人数: 191

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 0 至 17（—）
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 (For example, completion of the diary cards, return for follow-up visits)., •Subject receiving maintenance immunosuppressive therapy (refer to Glossary of terms for definition) for the prevention of allograft rejection for a minimum of one month (30 days) prior to randomisation (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 (note that abstinence is a method of contraception as defined in Section 12.6.2 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 randomisation (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.

排除标准

•Any primary kidney disease with a high incidence of recurrent primary kidney disease within the allograft., •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, History of more than one organ transplanted (that is, kidney-liver, simultaneous double kidney or kidney-other organ(s) transplanted)., •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., •History of unstable or progressive neurological disorder., •Subjects <= 5 years of age with a history of one or more simple or complex febrile seizures., Atypical Haemolytic Uraemic Syndrome., •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., •Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or planned administration of immunoglobulins during the duration of the study., •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., •Evidence of recurrent primary kidney disease within the current allograft., •Previous allograft loss secondary to recurrent primary kidney disease., Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment., Concurrent or planned participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product‡ (drug or medical device). ‡The only exception would be use of investigational or non-registered immunosuppressant(s), at the local/country level, which may be used if they are specifically prescribed for the prevention of allograft rejection and are: - available locally through compassionate use programs, - submitted for and pending local/country registration, - approved and registered for use in other countries with well-documented Summary of Product Characteristics (SmPC) or Prescribing Information (PI). - The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing., •Child in care (Please refer to the glossary of terms in the protocol for the definition of child in care)., •Pregnant or lactating female., •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine., •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., •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 prio

研究者

发起方

GlaxoSmithKline Biologicals

相似试验

进行中（未招募）

1 期

A study to evaluate different dose levels of GlaxoSmithKline (GSK) Biologicals’ investigational Respiratory Syncytial Virus (RSV) vaccine (GSK3888550A), based on the safety of the vaccine and the antibodies (body defences) that the body produces following the vaccine administration, when given to healthy non-pregnant womeHealthy volunteers (Prevention of RSV LRTI in infants)MedDRA version: 20.1Level: LLTClassification code 10035692Term: Pneumonia due to respiratory syncytial virusSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10038718Term: Respiratory syncytial virus bronchiolitisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10066741Term: Respiratory syncytial virus infection recurrentSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10061603Term: Respiratory syncytial virus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10052200Term: Respiratory syncytial virus infection NOSSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10067384Term: Respiratory syncytial virus pneumonitisSystem Organ Class: 10021881 - Infections and infestations

EUCTR2018-001340-62-FIGlaxoSmithKline Biologicals502

进行中（未招募）

1 期

EUCTR2018-001340-62-DEGlaxoSmithKline Biologicals500

已完成

4 期

Post marketing clinical trial to evaluate the reactogenicity profile of the Cuban vaccine against diphtheria, tetanus, and pertussis infections in infants.tetanus, diphtheria, whooping coughWhooping CoughCorynebacterium InfectionsActinomycetales InfectionsClostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBordetella InfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesTetanusDiphtheria

RPCEC00000049Finlay Institute57

招募中

2 期

Preliminary study: Safety and Immunological Response following COVID-19 Vaccination in COVID-19 survivorsCOVID-19 survivorsCOVID-19 Vaccination

TCTR20210720005Faculty of Medicine Siriraj Hospital180

进行中（未招募）

1 期

Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine when co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in EuropeHealthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations

EUCTR2017-004731-36-ITSanofi Pasteur Inc.1,540