a study to test glaxosmithkline's (gsk) candidate vaccine-gsk1437173a for prevention of shingles in children with kidney transplant

Conditions: Herpes Zoster

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 criteria:
inclusion criteria: * 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 exclusion criteria: 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). * 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.