Immunoresponse on pneumococcal vaccination of kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease. MedDRA version: 21.0 Level: LLT Classification code 10076412 Term: Chronic kidney disease stage 5 System Organ Class: 100000004857 MedDRA version: 21.1 Level: LLT Classification code 10069594 Term: Pneumococcal immunization System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10023438 Term: Kidney transplant System Org
Conditions
Interventions
Trade Name: Prevenar 13®
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARID serotype (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F og 23F).
Other descriptiv
Sponsors
Department of Infectious Diseases, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease. Over 18 years old Not pregnant Patient in nefrology outpatient clinic at Odense University Hospital or Zealand University Hospital, Roskilde or University Hospital Hovedstaden, Rigshospitalet. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Hypersensitivity to Diphtheria toxoid, active substance or excipients in the vaccines. Pneumovax vaccination within the last 12 months. Refuses to be vaccinated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A direct head to head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, for Prenevar 13 and Pneumovax, independently of the immunomodulatory therapy. ;Secondary Objective: A comparison of the pneumococcal antibody level pre and post vaccination (for Prenevar 13 and Pneumovax) in the different treatment groups (Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease).;Primary end point(s): The primary endpoint is a direct head-to-head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, independently of Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease.;Timepoint(s) of evaluation of this end point: December 2021 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoint is a direct head-to-head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, dependent of Kidney transplant recipients in immunomodulatory therapy or patients with end stage renal disease.;Timepoint(s) of evaluation of this end point: December 2021 | — |
Countries
Denmark
Contacts
Public ContactLykke Larsen
Department of Infectious Diseases, Odense University Hospital
Outcome results
None listed