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Determination of immune response after sequential pneumococcal vaccination using the 7-valent conjugate pneumococcal and the 23-valent pneumococcal polysaccharide vaccine in renal transplant recipients

Conditions
Immunisation of renal transplant patients against streptococcus pneumoniae by conjugated or non conjugated pneumococcal vaccination
Registration Number
EUCTR2007-004590-25-AT
Lead Sponsor
Medical University of Vienna
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Adult patients will be recruited at the transplant center of the Medical University of Vienna.
Patients will be eligable if between 6 months and 3 years had passed since their kidney transplant and if they have stable allograft function, as evidenced by creatinine level < 250 µl for 1 month prior involvement
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

splenectomy, pneumococcal vaccination within preceeding 5 years, any acute febrile illness in the 2 weeks prior to or at time of enrollment, use of intravenous immunoglobulis within precceding 6 months, history of severe allergic reaction or anaphylaxis, hemoglobin value < 10 g/dl at the time of inclusion

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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