Actively Recruiting
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
Led by GlaxoSmithKline · Updated on 2026-02-27
184
Participants Needed
31
Research Sites
387 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Parent or legal representative can comply with study requirements
- Written informed consent from parent/legal representative and assent from child if required
- Male or female aged 1 to 17 years at randomization
- Body weight at least 6 kg (13.23 pounds)
- Documented previous varicella vaccination, medically confirmed varicella, or seropositive for varicella zoster virus before transplant
- Kidney transplant occurred more than 6 months before randomization
- Received an ABO compatible kidney transplant
- Stable kidney function with less than 20% variability in recent creatinine measurements
- Receiving maintenance immunosuppressive therapy for at least 1 month before randomization
- Females of childbearing potential must use adequate contraception for 30 days before and during study plus 2 months after vaccination
You will not qualify if you...
- Primary kidney disease with high risk of recurrence in the transplant
- Evidence of recurrent kidney disease in the transplant
- Previous transplant loss due to recurrent kidney disease
- History of more than one organ transplanted
- Acute transplant rejection episode within 6 months before enrollment
- Unknown varicella zoster virus status before transplant
- Advanced chronic kidney disease
- Significant proteinuria (≥200 g/mol creatinine) of renal origin
- No multiple dialysis options if needed
- History of unstable or progressive neurological disorder
- Children 5 years or younger with any febrile seizures; children older than 5 with complex febrile seizures
- Varicella or shingles episode within 6 months before study day 1
- Autoimmune diseases except specified types
- Confirmed or suspected HIV or primary immunodeficiency
- Any condition posing additional risk per investigator
- History of allergic reaction to vaccine components
- Conditions making intramuscular injection unsafe
- Atypical Hemolytic Uremic Syndrome
- Use of investigational or non-registered products within 30 days before study
- Treatment for rejection within 6 months before enrollment
- Use of anti-CD20 or B-cell antibodies within 1 year before study
- Blood products within 3 months before study
- Immunoglobulins within 6 months before study
- Vaccines within 30 days before study except certain influenza vaccines
- Previous shingles vaccination or varicella vaccination within 6 months before study
- Planned shingles or varicella vaccination other than study vaccine during study
- Participation in other clinical studies with investigational or non-registered products during study
- Child in care
- Pregnant or breastfeeding females
- Females planning pregnancy or stopping contraception from 30 days before to 60 days after study
- Non-compliance with immunosuppressive therapy
- Incomplete pre-vaccination diary card
- Study personnel or immediate family members involved in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
GSK Investigational Site
Brussels, Belgium, 1020
Actively Recruiting
2
GSK Investigational Site
Ghent, Belgium, 9000
Actively Recruiting
3
GSK Investigational Site
Leuven, Belgium, 3000
Actively Recruiting
4
GSK Investigational Site
Liège, Belgium, 4000
Actively Recruiting
5
GSK Investigational Site
Bordeaux, France, 33000
Actively Recruiting
6
GSK Investigational Site
Lille, France, 59000
Actively Recruiting
7
GSK Investigational Site
Marseille, France, 13385
Actively Recruiting
8
GSK Investigational Site
Montpellier, France, 34295
Actively Recruiting
9
GSK Investigational Site
Nantes, France, 44093
Withdrawn
10
GSK Investigational Site
Paris, France, 75015
Actively Recruiting
11
GSK Investigational Site
Paris, France, 75019
Actively Recruiting
12
GSK Investigational Site
Toulouse, France, 31059
Actively Recruiting
13
GSK Investigational Site
Genova, Italy, 16147
Completed
14
GSK Investigational Site
Milan, Italy, 20122
Actively Recruiting
15
GSK Investigational Site
Padova, Italy, 35128
Actively Recruiting
16
GSK Investigational Site
Roma, Italy, 00165
Actively Recruiting
17
GSK Investigational Site
Torino, Italy, 10126
Actively Recruiting
18
GSK Investigational Site
Gdansk, Poland, 80-952
Actively Recruiting
19
GSK Investigational Site
BaracaldoVizcaya, Spain, 48903
Actively Recruiting
20
GSK Investigational Site
Espluges de Llobregat, Spain, 08950
Completed
21
GSK Investigational Site
HebrOn, Spain, 08035
Actively Recruiting
22
GSK Investigational Site
Madrid, Spain, 28007
Actively Recruiting
23
GSK Investigational Site
Madrid, Spain, 28046
Actively Recruiting
24
GSK Investigational Site
Seville, Spain, 41013
Actively Recruiting
25
GSK Investigational Site
Birmingham, United Kingdom, B4 6NH
Completed
26
GSK Investigational Site
Cardiff, United Kingdom, CF14 4XW
Completed
27
GSK Investigational Site
Glasgow Strathclyde, United Kingdom, G51 4TF
Actively Recruiting
28
GSK Investigational Site
London, United Kingdom, WC1N 3JH
Actively Recruiting
29
GSK Investigational Site
Manchester, United Kingdom, M13 9WL
Actively Recruiting
30
GSK Investigational Site
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
31
GSK Investigational Site
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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