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.
- Conditions
- Prevention of Herpes Zoster in immunocompromised subjects aged 1-17 yearsTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2022-502784-37-00
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 191
•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.
•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
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