Szczepionka: badanie kliniczne fazy I/II

Kryteria wyłączenia kto nie może wziąć udziału (49)

1. Medical conditions
2. Any primary kidney disease with a high incidence of recurrent primary kidney disease within the allograft
3. Evidence of recurrent primary kidney disease within the current allograft
4. Previous allograft loss secondary to recurrent primary kidney disease
5. History of more than one organ transplanted (that is, kidney-liver, simultaneous double kidney or kidney-other organ(s) transplanted).
6. Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment
7. Panel Reactive Antibodies (PRA) calculated PRA (cPRA) or Calculated Reaction Frequency (cRF) score that is unknown at the time of transplant
8. VZV serostatus unknown prior to transplant
9. Subjects with advanced chronic kidney disease
10. 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)
11. Subjects without multiple dialysis options in the event acute or chronic dialysis needed.
12. History of unstable or progressive neurological disorder.
13. Subjects ≤ 5 years of age with a history of one or more simple or complex febrile seizures
14. Subjects > 5 years with history of one or more complex febrile seizures
15. Occurrence of a varicella or HZ episode by clinical history within the 6 months (180 days) preceding Visit Day 1
16. Any autoimmune disease, with the following exceptions which do not constitute an exclusion criterion:
17. IgA nephropathy
18. Rapidly progressive glomerulonephritis
19. Membranous glomerulonephritis
20. Idiopathic Type I membranoproliferative glomerulonephritis
21. Diabetes mellitus (type 1 and 2) with diabetic nephropathy
22. Confirmed or suspected Human Immunodeficiency Virus or primary immunodeficiency disease
23. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
24. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
25. Any condition which, in the judgement of the investigator would make intramuscular injection unsafe.
26. Atypical Haemolytic Uraemic Syndrome. Prior/Concomitant therapy
27. 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.
28. Subject in receipt of treatment for rejection during the six months (180 days) prior to enrolment.
29. 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.
30. Administration of blood products 3 months (90 days) prior to Visit Day 1 or planned administration during the duration of the study.
31. Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or planned administration of immunoglobulins during the duration of the study.
32. 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.
33. Previous vaccination against HZ
34. Varicella vaccination within the 6 months (180 days) preceding Visit Day 1
35. 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
36. 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
37. available locally through compassionate use programs,
38. submitted for and pending local/country registration,
39. approved and registered for use in other countries with well-documented Summary of Product Characteristics or Prescribing Information
40. The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing Other exclusions
41. Child in care
42. Pregnant or lactating female
43. 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.
44. 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.
45. Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit
46. Completion must cover the 7 days immediately prior to randomisation (Visit Day 1).
47. Completion is defined as a minimum of 6 days completed.
48. 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.
49. Any study personnel or their immediate dependants, family, or household member.