Herpes Zoster Renal transplant Pediatric population
Conditions
Interventions
Product Name: PED-HZ/su (Pediatric Herpes Zoster subunit (HZ/su) vaccine)
Product Code: gE (50µg) + AS01E
Pharmaceutical Form: Powder and suspension for suspension for
Sponsors
GlaxoSmithKline S.A.
Eligibility
Sex/Gender
All
Inclusion 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 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 •Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment or receipt of treatment for rejection during 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 •Subjects without multiple dialysis options in the event acute or chronic dialysis needed. •History of unstable or progressive neurological disorder. •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 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. Subjects on treatment for rejection with ongoing treatment with T-cell depleting Ab or IL2R Ab •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 prior to 3 months (90 days) of enrolment or planned administration during the duration of the study •Administration of immunoglobulins prior to 6 months (180 days) of enrolment or planned administration of immunoglobulins during the duration of the study •Administration or planned administration of a vaccine in the period starting 30 days before Visit Day 1 up to Visit Month 2 •Previous vaccination against HZ •Varicella vaccination within the 6 months (180 days) preceding Visit Day 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate reactogenicity (up to Day 7) and safety (up to Month 2) following administration of PED-HZ/su in each age category (1-11 and 12-17 years) •To evaluate humoral immune responses following administration of PED-HZ/su in each age category (1-11 and 12-17 years) at Month 2 ; Secondary Objective: •To evaluate safety following administration of PED-HZ/su in each age category (1-11 and 12-17 years) from Day 1 up to Month 13 •To describe the occurrence of cases of HZ in each age category (1-11 and 12-17 years) •To evaluate reactogenicity and safety for the entire study population (1-17 years) following administration of PED-HZ/su •To characterise humoral immune responses following administration of PED-HZ/su ; Primary end point(s): 1. Number of subjects from the interventional groups, with solicited local adverse events (AEs) 2. Number of subjects from the interventional groups, with solicited general AEs 3. Number of subjects from the control groups with solicited general symptoms 4. Number of subjects from the control groups with solicited general symptoms 5. Number of subjects from the interventional groups with unsolicited AEs after each vaccination 6. Number of subjects from the control groups with unsolicited symptoms 7. Number of subjects from the control groups with unsolicited symptoms 8. Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection 9. Number of subjects from the interventional groups with seizures 10. Number of subjects from the non-interventional groups with seizures 11. Number of subjects from the non-interventional groups with seizures 12. Numbe | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13 2. Occurrence of Herpes Zoster cases 3. Number of subjects from the interventional pooled age group with solicited local AEs 4. Number of subjects from the interventional pooled age group with solicited general AEs 5. Number of subjects from the non-interventional pooled age group with solicited general symptoms 6. Number of subjects from the interventional pooled age group with unsolicited AEs after each vaccination 7. Number of subjects from the non-interventional pooled age group with unsolicited symptoms 8. Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections 9. Number of subjects from the pooled age groups with HZ 10. Number of subjects from the interventional pooled age group with seizures 11. Number of subjects from the non-interventional pooled age group with seizures 12. Number of subjects from the interventional pooled age group with generalized convulsive seizures 13. Number of subjects from the non-interventional pooled age group with generalized convulsive seizures 14. Vaccine Response Rate (VRR) for Anti-glycoprotein (Anti-gE) antibody concentrations 15. Median fold increase of anti-gE antibody concentrations 16. Percentage of subjects with anti-gE antibody concentrations in terms of GMCs 17. Percentage of subjects in the interventional pooled age group, with Anti-gE antibody concentrations in terms of GMCs ; Timepoint(s) of evaluation of this end point: 1. From Visit Day 1 up to Visit Month 13 2. From Visit Day 1 until Visit Month 13 3. Within 7 day | — |
Countries
France, Italy, Spain, United Kingdom
Contacts
Public ContactCENTRO DE INFORMACIÓN
GlaxoSmithKline S.A.
Outcome results
None listed