search
Back to results

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

Primary Purpose

Herpes Zoster

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PED-HZ/su
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Herpes Zoster

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

PED-HZ/su 12-17 Group

Control 12-17 Group

PED-HZ/su 1-11 Group

Control 1-11 Group

Arm Description

Paediatric renal transplant recipients aged 12 to 17 years old, receiving 2 doses of the investigational vaccine (PED HZ/su)

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

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.

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

Outcomes

Primary Outcome Measures

Number of subjects from the interventional groups, with solicited local adverse events (AEs)
Assessed solicited local AEs are pain, redness and swelling at the injection site. Pain includes tenderness. Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects < 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Number of subjects from the interventional groups, with solicited general AEs
Assessed solicited general AEs among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite Gastrointestinal (GI) symptoms** Assessed solicited general AEs among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects < 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Number of subjects from the control groups with solicited general symptoms
Assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite GI symptoms** Assessed solicited general symptoms among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain As subjects from the control group are not vaccinated, they will not complete the diary card for local solicited symptoms.
Number of subjects from the control groups with solicited general symptoms
Assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite GI symptoms** Assessed solicited general symptoms among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain
Number of subjects from the interventional groups with unsolicited AEs after each vaccination
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the control groups with unsolicited symptoms
An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the control groups with unsolicited symptoms
An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury. The reporting period for any renal allograft rejection is from Visit Day 1 to the study end (month 2).
Number of subjects from the interventional groups with seizures
All seizures occurring within 30 days following study vaccination are reported.
Number of subjects from the non-interventional groups with seizures
All seizures occurring within 30 days after visit day 1 are reported, for the control groups.
Number of subjects from the non-interventional groups with seizures
All seizures occurring within 30 days of visit month 1 are reported, for the control groups
Number of subjects from the interventional groups with generalized convulsive seizures
Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure.
Number of subjects from the non-interventional groups with generalized convulsive seizures
Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Number of subjects from the non-interventional groups with generalized convulsive seizures
Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
The geometric mean concentration (GMC) calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation

Secondary Outcome Measures

Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury. This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Occurrence of Herpes Zoster cases
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Number of subjects from the interventional pooled age group with solicited local AEs
The pooled age group includes all subjects aged 1-17 years. The assessed local AEs solicited are: Pain Redness Swelling Note: Pain includes tenderness.
Number of subjects from the interventional pooled age group with solicited general AEs
The pooled age group includes all subjects aged 1-17 years. The assessed solicited general AEs among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite Gastrointestinal (GI) symptoms** The assessed solicited general AEs among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain
Number of subjects from the non-interventional pooled age group with solicited general symptoms
The pooled age group includes all subjects aged 1-17 years. The assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite GI symptoms** The assessed solicited general symptoms among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain As subjects from the control group are not vaccinated, they will not complete the diary card for local solicited symptoms.
Number of subjects from the interventional pooled age group with unsolicited AEs after each vaccination
The pooled age group includes all subjects aged 1-17 years. An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
The pooled age group includes all subjects aged 1-17 years. An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
The pooled age group includes all subjects aged 1-17 years. An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury.
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury.
Number of subjects from the pooled age groups with HZ
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella. This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Number of subjects from the interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring within 30 days following study vaccination are reported
Number of subjects from the non-interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit day 1 are reported
Number of subjects from the non-interventional pooled age group with seizures
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit month 1 are reported
Number of subjects from the interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years. Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years. Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
The pooled age group includes all subjects aged 1-17 years. Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Vaccine Response Rate (VRR) for Anti-glycoprotein (Anti-gE) antibody concentrations
The Vaccine Response Rate for anti-gE antibodies is defined as the percentage of subjects who have at least: a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline. This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Median fold increase of anti-gE antibody concentrations
Median fold increase in antibody concentration with 95% Confidence Interval is tabulated for the interventional groups by age strata (1-11 years and 12-17 years) This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Percentage of subjects with anti-gE antibody concentrations in terms of GMCs
GMC calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation
Percentage of subjects in the interventional pooled age group, with Anti-gE antibody concentrations in terms of GMCs
GMC calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation. Median fold increase in antibody concentration with 95% Confidence Interval is to be tabulated for the interventional groups by pooled age category (1-17 years). This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)

Full Information

First Posted
July 1, 2019
Last Updated
December 6, 2022
Sponsor
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT04006808
Brief Title
A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
March 25, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PED-HZ/su 12-17 Group
Arm Type
Experimental
Arm Description
Paediatric renal transplant recipients aged 12 to 17 years old, receiving 2 doses of the investigational vaccine (PED HZ/su)
Arm Title
Control 12-17 Group
Arm Type
No Intervention
Arm Description
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
Arm Title
PED-HZ/su 1-11 Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control 1-11 Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
PED-HZ/su
Intervention Description
GSK's candidate vaccine- PED-HZ/su. is administered intramuscularly in the deltoid of the non-dominant arm, on a two-dose schedule in the two investigational groups.
Primary Outcome Measure Information:
Title
Number of subjects from the interventional groups, with solicited local adverse events (AEs)
Description
Assessed solicited local AEs are pain, redness and swelling at the injection site. Pain includes tenderness. Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects < 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the interventional groups, with solicited general AEs
Description
Assessed solicited general AEs among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite Gastrointestinal (GI) symptoms** Assessed solicited general AEs among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain Note: GSK diary cards for collecting solicited local and general AEs/symptoms is different for subjects < 6 years and ≥ 6 years. Hence the age category of 1-11 years is further split to 1-5 years and 6-11 years.
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the control groups with solicited general symptoms
Description
Assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite GI symptoms** Assessed solicited general symptoms among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain As subjects from the control group are not vaccinated, they will not complete the diary card for local solicited symptoms.
Time Frame
Within 7 days after Visit Day 1
Title
Number of subjects from the control groups with solicited general symptoms
Description
Assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite GI symptoms** Assessed solicited general symptoms among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain
Time Frame
Within 7 days after Visit Month 1
Title
Number of subjects from the interventional groups with unsolicited AEs after each vaccination
Description
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Time Frame
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the control groups with unsolicited symptoms
Description
An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Time Frame
Within 30 days after Visit Day 1
Title
Number of subjects from the control groups with unsolicited symptoms
Description
An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Time Frame
Within 30 days after Visit Month 1
Title
Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection.
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury. The reporting period for any renal allograft rejection is from Visit Day 1 to the study end (month 2).
Time Frame
From Visit Day 1 up to Visit Month 2
Title
Number of subjects from the interventional groups with seizures
Description
All seizures occurring within 30 days following study vaccination are reported.
Time Frame
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional groups with seizures
Description
All seizures occurring within 30 days after visit day 1 are reported, for the control groups.
Time Frame
Within 30 days after Visit Day 1
Title
Number of subjects from the non-interventional groups with seizures
Description
All seizures occurring within 30 days of visit month 1 are reported, for the control groups
Time Frame
Within 30 days after Visit Month 1
Title
Number of subjects from the interventional groups with generalized convulsive seizures
Description
Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure.
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional groups with generalized convulsive seizures
Description
Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Time Frame
Within 7 days after Visit Day 1
Title
Number of subjects from the non-interventional groups with generalized convulsive seizures
Description
Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Time Frame
Within 7 days after Visit Month 1
Title
Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
Description
The geometric mean concentration (GMC) calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation
Time Frame
At Month 2 (one-month post-dose 2)
Secondary Outcome Measure Information:
Title
Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury. This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Time Frame
From Visit Day 1 up to Visit Month 13
Title
Occurrence of Herpes Zoster cases
Description
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Time Frame
From Visit Day 1 until Visit Month 13
Title
Number of subjects from the interventional pooled age group with solicited local AEs
Description
The pooled age group includes all subjects aged 1-17 years. The assessed local AEs solicited are: Pain Redness Swelling Note: Pain includes tenderness.
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the interventional pooled age group with solicited general AEs
Description
The pooled age group includes all subjects aged 1-17 years. The assessed solicited general AEs among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite Gastrointestinal (GI) symptoms** The assessed solicited general AEs among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional pooled age group with solicited general symptoms
Description
The pooled age group includes all subjects aged 1-17 years. The assessed solicited general symptoms among Infants/Toddlers/Children < 6 years are: Drowsiness Fever* Irritability/Fussiness Loss of appetite GI symptoms** The assessed solicited general symptoms among Children ≥ 6 years are: Fatigue Fever* GI symptoms** Headache Myalgia Shivering (chills) Fever is defined as temperature ≥ 38.0°C/100.4°F **GI symptoms include nausea, vomiting, diarrhoea, and/or abdominal pain As subjects from the control group are not vaccinated, they will not complete the diary card for local solicited symptoms.
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the interventional pooled age group with unsolicited AEs after each vaccination
Description
The pooled age group includes all subjects aged 1-17 years. An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Time Frame
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
Description
The pooled age group includes all subjects aged 1-17 years. An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Time Frame
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional pooled age group with unsolicited symptoms
Description
The pooled age group includes all subjects aged 1-17 years. An unsolicited symptom is any symptom reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited adverse event.
Time Frame
Within 30 days after Visit Month 1
Title
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury.
Time Frame
From Visit Day 1 until Visit Month 2
Title
Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity pIMDs are sub sets of Adverse events of special interest (AESIs) that include autoimmune disease and other inflammatory and/neurological disorders of interest, which may or may not have autoimmune aetiology. The renal allograft rejections are biopsy confirmed pathophysiological changes indicative of rejection. The rejection is graded for severity and extent of histologic inflammation and injury.
Time Frame
From Visit Day 1 until Visit Month 13
Title
Number of subjects from the pooled age groups with HZ
Description
HZ may present classically with a unilateral, dermatomal rash that is associated with pain, pruritus, allodynia or other altered sensation. In this population, disseminated HZ may occur and present with a generalized rash with systemic symptoms such as fever. All children enrolled in the trial have a history of primary VZV infection or vaccination and in the presence of immunosuppression, disseminated HZ cannot be distinguished clinically from varicella. This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Time Frame
From Visit Day 1 until Visit Month 13
Title
Number of subjects from the interventional pooled age group with seizures
Description
The pooled age group includes all subjects aged 1-17 years. All seizures occurring within 30 days following study vaccination are reported
Time Frame
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional pooled age group with seizures
Description
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit day 1 are reported
Time Frame
Within 30 days after Visit Day 1
Title
Number of subjects from the non-interventional pooled age group with seizures
Description
The pooled age group includes all subjects aged 1-17 years. All seizures occurring with 30 days after visit month 1 are reported
Time Frame
Within 30 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the interventional pooled age group with generalized convulsive seizures
Description
The pooled age group includes all subjects aged 1-17 years. Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
Description
The pooled age group includes all subjects aged 1-17 years. Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Time Frame
Within 7 days after each vaccination (vaccines administered on day 1 and month 1)
Title
Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
Description
The pooled age group includes all subjects aged 1-17 years. Generalized convulsive seizures are classified as follows: Level 1 of diagnostic certainty: witnessed sudden loss of consciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 2 of diagnostic certainty: history of unconsciousness AND generalized, tonic, clonic, tonic-clonic, or atonic motor manifestations Level 3 of diagnostic certainty: history of unconsciousness AND other generalized motor manifestations Level 4 of diagnostic certainty: reported generalized convulsive seizure with insufficient evidence to meet the case definitions for Level 1, 2 or 3 of diagnostic certainty above Level 5 of diagnostic certainty: Not a case of generalized convulsive seizure Only levels 1 to 3 of generalized convulsive seizures will comprise the analysis for this outcome measure
Time Frame
Within 7 days after Visit Month 1
Title
Vaccine Response Rate (VRR) for Anti-glycoprotein (Anti-gE) antibody concentrations
Description
The Vaccine Response Rate for anti-gE antibodies is defined as the percentage of subjects who have at least: a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the pre-vaccination anti-gE Ab concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the post-dose 2 anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for subjects who are seronegative at baseline. This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Time Frame
At Month 2 and Month 13
Title
Median fold increase of anti-gE antibody concentrations
Description
Median fold increase in antibody concentration with 95% Confidence Interval is tabulated for the interventional groups by age strata (1-11 years and 12-17 years) This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Time Frame
At Month 2 and Month 13
Title
Percentage of subjects with anti-gE antibody concentrations in terms of GMCs
Description
GMC calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation
Time Frame
At Day 1 (pre-vaccination) and Month 13
Title
Percentage of subjects in the interventional pooled age group, with Anti-gE antibody concentrations in terms of GMCs
Description
GMC calculations are performed by taking the anti log of the mean of the log concentration transformations. Antibody concentrations below the cut-off of the assay will be given an arbitrary value equal to half the cut-off for GMC calculation. Median fold increase in antibody concentration with 95% Confidence Interval is to be tabulated for the interventional groups by pooled age category (1-17 years). This outcome measure is analysed during epoch 002 (day 1 to month 2) and during epoch 003 (month 2- month 13)
Time Frame
At Day 1, Month 2 and Month 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jérôme Harambat
Facility Name
GSK Investigational Site
City
Lille
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Annie Manucci-Lahoche
Facility Name
GSK Investigational Site
City
Marseille cedex 5
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Florentine Garaix
Facility Name
GSK Investigational Site
City
Montpellier cedex
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Marc Fila
Facility Name
GSK Investigational Site
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Gwénaëlle Roussey-Kesler
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Olivia Gillion-Boyer
Facility Name
GSK Investigational Site
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Julien Hogan
Facility Name
GSK Investigational Site
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Stéphane Decramer
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Isabella Guzzo
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16147
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Alberto Magnasco
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Giovanni Montini
Facility Name
GSK Investigational Site
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Roberta Camilla
Facility Name
GSK Investigational Site
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Elisa Benetti
Facility Name
GSK Investigational Site
City
Baracaldo/Vizcaya
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Mireia Aguirre Meñica
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Xavier Martínez Gómez
Facility Name
GSK Investigational Site
City
Esplugues De Llobregat. Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Álvaro Domingo Madrid Aris
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Daniel Barraca Núñez
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Teresa del Rosal Rabes
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Francisco De la Cerda Ojeda
Facility Name
GSK Investigational Site
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Mordi Muorah
Facility Name
GSK Investigational Site
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Shivaram Hegde
Facility Name
GSK Investigational Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Ben Reynolds
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Stephen Marks
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Mohan Shenoy
Facility Name
GSK Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Jon Jin Kim
Facility Name
GSK Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Matthew Harmer

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

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

We'll reach out to this number within 24 hrs