Phase
Condition
Chickenpox (Varicella Zoster Infection)
Rash
Shingles
Treatment
N/AClinical Study ID
Ages 1-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 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 localrequirements.
- 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% variability betweenthe last two creatinine measurements or based on investigator opinion after review ofmultiple creatinine measurements.
- Subject receiving maintenance immunosuppressive therapy for the prevention ofallograft rejection for a minimum of one month (30 days) prior to randomization (VisitDay 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 hasagreed to continue adequate contraception during the entire treatment period andfor 2 months after completion of the vaccination series
Exclusion
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 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 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 any componentof 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), or planneduse 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 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 plannedadministration during the duration of the study.
- Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or plannedadministration 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 thestudy period, in which the subject has been or will be exposed to an investigational or anon-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 to VisitDay 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 Visit Day 1 and the opportunity to comply with the completion of the 7-day pre-vaccinationdiary card prior to the new planned Visit Day 1.
- Any study personnel or their immediate dependants, family, or household member.
Study Design
Connect with a study center
GSK Investigational Site
Bordeaux, 33000
FranceActive - Recruiting
GSK Investigational Site
Lille, 59000
FranceActive - Recruiting
GSK Investigational Site
Marseille cedex 5, 13385
FranceActive - Recruiting
GSK Investigational Site
Montpellier cedex, 34295
FranceActive - Recruiting
GSK Investigational Site
Nantes cedex 1, 44093
FranceActive - Recruiting
GSK Investigational Site
Paris, 75015
FranceActive - Recruiting
GSK Investigational Site
Toulouse cedex 9, 31059
FranceActive - Recruiting
GSK Investigational Site
Roma, Lazio 00165
ItalyActive - Recruiting
GSK Investigational Site
Genova, Liguria 16147
ItalyActive - Recruiting
GSK Investigational Site
Milano, Lombardia 20122
ItalyActive - Recruiting
GSK Investigational Site
Torino, Piemonte 10126
ItalyActive - Recruiting
GSK Investigational Site
Padova, Veneto 35128
ItalyActive - Recruiting
GSK Investigational Site
Baracaldo/Vizcaya, 48903
SpainActive - Recruiting
GSK Investigational Site
Barcelona, 08035
SpainActive - Recruiting
GSK Investigational Site
Esplugues De Llobregat. Barcelona, 08950
SpainActive - Recruiting
GSK Investigational Site
Madrid, 28007
SpainActive - Recruiting
GSK Investigational Site
Sevilla, 41013
SpainActive - Recruiting
GSK Investigational Site
Birmingham, B4 6NH
United KingdomActive - Recruiting
GSK Investigational Site
Cardiff, CF14 4XW
United KingdomActive - Recruiting
GSK Investigational Site
Glasgow, G51 4TF
United KingdomActive - Recruiting
GSK Investigational Site
London, WC1N 3JH
United KingdomActive - Recruiting
GSK Investigational Site
Manchester, M13 9WL
United KingdomActive - Recruiting
GSK Investigational Site
Nottingham, NG7 2UH
United KingdomActive - Recruiting
GSK Investigational Site
Southampton, SO16 6YD
United KingdomActive - Recruiting
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