A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
NCT ID: NCT04006808
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
184 participants
INTERVENTIONAL
2019-10-25
2027-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant
NCT02058589
A Study to Test GlaxoSmithKline's (GSK) Herpes Zoster (HZ) Subunit Vaccine's Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses of the Vaccine Are Safe and Able to Generate an Immune Response
NCT04176939
Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older
NCT02735915
Evaluation of Immunogenicity, Reactogenicity and Safety of HBV-MPL Vaccine vs Engerix™-B, in Haemodialysis Patients
NCT00699231
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
NCT00697775
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PED-HZ/su 12-17 Group
Paediatric renal transplant recipients aged 12 to 17 years old, receiving 2 doses of the investigational vaccine (PED HZ/su)
PED-HZ/su
GSK's candidate vaccine- PED-HZ/su. is administered intramuscularly in the deltoid of the non-dominant arm, on a two-dose schedule in the two investigational groups.
Control 12-17 Group
Paediatric renal transplant recipients aged 12 to 17 years old, not receiving the investigational vaccine but being treated according to the local standard of care
No interventions assigned to this group
PED-HZ/su 1-11 Group
Paediatric renal transplant recipients aged 1 to 11 years old, receiving 2 doses of the investigational vaccine (PED HZ/su).
Enrolment into this group will be in a staggered manner. Following enrolment into the PED-HZ/su 12-17 group, a safety evaluation of data collected up to visit month 2 will be performed. Upon favourable outcome of the evaluation, enrolment into this group will begin.
PED-HZ/su
GSK's candidate vaccine- PED-HZ/su. is administered intramuscularly in the deltoid of the non-dominant arm, on a two-dose schedule in the two investigational groups.
Control 1-11 Group
Paediatric renal transplant recipients aged 1 to 11 years old, not receiving the investigational vaccine but being treated according to the local standard of care
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PED-HZ/su
GSK's candidate vaccine- PED-HZ/su. is administered intramuscularly in the deltoid of the non-dominant arm, on a two-dose schedule in the two investigational groups.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
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 days after Visit 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
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.
* Subjects 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.
1 Year
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Bordeaux, , France
GSK Investigational Site
Lille, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Toulouse, , France
GSK Investigational Site
Genova, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Padua, , Italy
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Torino, , Italy
GSK Investigational Site
Gdansk, , Poland
GSK Investigational Site
BaracaldoVizcaya, , Spain
GSK Investigational Site
Espluges de Llobregat, , Spain
GSK Investigational Site
HebrOn, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Seville, , Spain
GSK Investigational Site
Birmingham, , United Kingdom
GSK Investigational Site
Cardiff, , United Kingdom
GSK Investigational Site
Glasgow Strathclyde, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Manchester, , United Kingdom
GSK Investigational Site
Nottingham, , United Kingdom
GSK Investigational Site
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Mollo A, Peri M, Lodi L, Gissi A, Lionetti P, Marrani E, Mastrolia MV, Tondo A, Tintori V, Sardi I, Indolfi G, Trapani S, Galli L, Venturini E, Astorino V, Azzari C, Ricci S. Considering recombinant herpes zoster vaccine for fragile pediatric patients: A new opportunity. Vaccine. 2025 Apr 19;53:127072. doi: 10.1016/j.vaccine.2025.127072. Epub 2025 Apr 7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-000607-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
200075
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.