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

Who is this study for? Immunocompromised pediatric kidney transplant recipients aged 1-17 years
What treatments are being studied? PED-HZ/su
Status: Recruiting
Location: See all (31) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
Belgium
GSK Investigational Site
RECRUITING
Brussels
GSK Investigational Site
RECRUITING
Ghent
GSK Investigational Site
RECRUITING
Leuven
GSK Investigational Site
RECRUITING
Liège
France
GSK Investigational Site
RECRUITING
Bordeaux
GSK Investigational Site
RECRUITING
Lille
GSK Investigational Site
RECRUITING
Marseille
GSK Investigational Site
RECRUITING
Montpellier
GSK Investigational Site
WITHDRAWN
Nantes
GSK Investigational Site
RECRUITING
Paris
GSK Investigational Site
RECRUITING
Paris
GSK Investigational Site
RECRUITING
Toulouse
Italy
GSK Investigational Site
COMPLETED
Genova
GSK Investigational Site
RECRUITING
Milan
GSK Investigational Site
RECRUITING
Padua
GSK Investigational Site
RECRUITING
Roma
GSK Investigational Site
RECRUITING
Torino
Poland
GSK Investigational Site
RECRUITING
Gdansk
Spain
GSK Investigational Site
RECRUITING
Baracaldovizcaya
GSK Investigational Site
COMPLETED
Espluges De Llobregat
GSK Investigational Site
RECRUITING
Hebron
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Madrid
GSK Investigational Site
RECRUITING
Seville
United Kingdom
GSK Investigational Site
RECRUITING
Birmingham
GSK Investigational Site
COMPLETED
Cardiff
GSK Investigational Site
RECRUITING
Glasgow Strathclyde
GSK Investigational Site
RECRUITING
London
GSK Investigational Site
RECRUITING
Manchester
GSK Investigational Site
RECRUITING
Nottingham
GSK Investigational Site
RECRUITING
Southampton
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2019-10-25
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 184
Treatments
Experimental: 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)
No_intervention: 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
Experimental: 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.
No_intervention: 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
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov