Research Project

Project Title:

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 immunocomprom

Project Type:

Clinical Trial, Enrolment ongoing
Adjunct biobank: Serum, Plasma

Disease group(s):

Pediatric kidney transplantation

Project Summary:

ZOSTER-047 will be conducted to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su (GlaxoSmithKline Biologicals SA’s [GSK’s] vaccine candidate for the prevention of HZ in immunocompromised paediatric population) in paediatric renal transplant recipients in age groups 1-11 and 12-17 years.

Lead principal investigator(s):

Giovanni Montini, Milan

Co-investigator(s):

Sara Testa, Milan

Project Period:

09/2019   -   09/2050

Sponsors:

Industry

Project web page:

https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000607-33/IT

EudraCT Nr.:

2019-000607-33

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