A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant

Inclusion Criteria:

• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s) who, in the opinionof the investigator, can and will comply, with the requirements of the protocol

• Written or witnessed/thumb printed informed consent obtained from theparent(s)/LAR(s) of the subject prior to performance of any study specificprocedure.

• Written informed assent obtained from the subjects when applicable according tolocal requirements.

• A male or female between, and including, 1 and 17 years of age at the time ofrandomisation (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% variabilitybetween the last two creatinine measurements or based on investigator opinion afterreview of multiple creatinine measurements.

• Subject receiving maintenance immunosuppressive therapy for the prevention ofallograft 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 thesubject

• has practiced adequate contraception for 30 days prior to Visit Day 1 and hasagreed to continue adequate contraception during the entire treatment periodand 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 diseasewithin 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, simultaneousdouble 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 ReactionFrequency (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 renalorigin (an example of non-renal origin is proteinuria from mucus in a reconstructedbladder)

• Subjects without multiple dialysis options in the event acute or chronic dialysisneeded.

• History of unstable or progressive neurological disorder.

• Subjects ≤ 5 years of age with a history of one or more simple or complex febrileseizures

• 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 (180days) preceding Visit Day 1

• Any autoimmune disease, with the following exceptions which do not constitute anexclusion 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 immunodeficiencydisease

• Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the subject due to participation in the study

• History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the vaccine

• Any condition which, in the judgement of the investigator would make intramuscularinjection unsafe.

• Atypical Haemolytic Uraemic Syndrome.

Prior/Concomitant therapy

• Use of any investigational or non-registered product other than the study vaccineduring the period starting 30 days before Visit Day 1 (Day -29 to Day -1), orplanned use during the study period.

• Subject in receipt of treatment for rejection during the six months (180 days) priorto enrolment.

• Use of anti-CD20 or other B-cell monoclonal antibody agents within 1 year of VisitDay 1 or planned administration during the duration of the study.

• Administration of blood products 3 months (90 days) prior to Visit Day 1 or plannedadministration during the duration of the study.

• Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 orplanned administration of immunoglobulins during the duration of the study.

• Administration or planned administration of a vaccine within 30 days prior to VisitDay 1 up to Visit Month 2 with the exception of an inactivated or subunit influenzavaccine which may be given 8 days prior to or 14 days after Visit Day 1 and 8 daysprior 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 aninvestigational 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 ofProduct Characteristics or Prescribing Information

• The name of the active component(s) of these immunosuppressants must be provided inthe concomitant medication listing

Other exclusions

• Child in care

• Pregnant or lactating female

• Female planning to become pregnant or planning to discontinue contraceptiveprecautions (if of childbearing potential) between one month (30 days) prior toVisit Day 1 through two months (60 days) after Visit Month 1.

• Evidence or high suspicion, in the opinion of the investigator, of non-compliance ornon-adherence to use of induction and/or maintenance immunosuppressive therapies.

• Failure to fully complete the 7-day pre-vaccination diary card distributed at thePre-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 VisitDay 1 and the opportunity to comply with the completion of the 7-daypre-vaccination diary card prior to the new planned Visit Day 1.

• Any study personnel or their immediate dependants, family, or household member.