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Prevention study for Herpes Zoster
Official title A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
ClinicalTrials.gov ID: NCT04006808
What this study is testing
What is PED-HZ/su?
PED-HZ/su is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for herpes zoster.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant recipients aged 1-17 years
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 17
You may be able to join if
- people' parent(s)/Legally Acceptable Representative(s) [LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of...
- Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific...
- Written informed assent obtained from the people 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.
You likely can't join if
- 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).
- people with an episode of acute allograft rejection over the six months (180 days) prior to enrolment
See the full eligibility criteria
Who can join
- people' 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 people 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.
- people 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 people 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
What rules you out
- 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).
- people 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
- people 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)
- people without multiple dialysis options in the event acute or chronic dialysis needed.
- History of unstable or progressive neurological disorder.
- people ≤ 5 years of age with a history of one or more simple or complex febrile seizures
- people \> 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. Prior/Concomitant therapy
- 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.
- 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 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...
- 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 Prior/Concurrent clinical study experience
- 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
- 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 or Prescribing Information
- The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing Other exclusions
- Child in care
- Pregnant or lactating female
- Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) between one month (30 days) prior to Visit Day 1 through two months (60 days) after Visit Month 1.
- Evidence or high suspicion, in the opinion of the investigator, of non-compliance or non-adherence to use of induction and/or maintenance immunosuppressive therapies.
- Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit
- Completion must cover the 7 days immediately prior to randomisation (Visit Day 1).
- Completion is defined as a minimum of 6 days completed.
- people with less than 6 days completed may be offered a new date for Visit Day 1 and the opportunity to comply with the completion of the 7-day pre-vaccination diary card prior to the new planned Visit Day 1.
- Any study personnel or their immediate dependants, family, or household member.
The study team makes the final eligibility decision.
Where it's taking place
- Brussels, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Bordeaux, France
- Lille, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Toulouse, France
- Genova, Italy
- Milan, Italy
- Padova, Italy
- Roma, Italy
- Torino, Italy
- Gdansk, Poland
- BaracaldoVizcaya, Spain
- Espluges de Llobregat, Spain
- HebrOn, Spain
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brussels, Belgium; Ghent, Belgium; Leuven, Belgium; Liège, Belgium; Bordeaux, France; Lille, France and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.