Prevenar13
BiologicalPrevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
NCT Number: NCT01781871
Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. The incidence rate of invasive pneumococcal disease is considerably higher among organ transplant patients than in healthy individuals. Routine immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine has been shown to be more immunogenic and safe in some other subgroups of immunocompromised patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 4
Helsinki University Central Hospital, Helsinki, HUS, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
0.5ml Pneumovax injected intramuscularly at day 1.
Time frame: baseline and 4 weeks after the first vaccination
Time frame: baseline and 4 weeks after the second vaccination
Time frame: from vaccination upto 1 week
Questionaire and phone interview assessment of vaccination reactions and adverse effects.
Time frame: at 1 and 2 months after the vaccination
Urine analyses and creatinine measurement with kidney transplant patients. Alanine aminotransferase measurement with liver transplant patients.
Helsinki University Central Hospital
Other
Immunogenicity of Repeated Dose 13-valent Pneumococcal Conjugate Vaccine Compared to the Existing Recommended Protocol of Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients
Acronym: SOT13
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