Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.
Two part clinical trial designed to evaluate the efficacy of StaphVAX in adults on hemodialysis. Part A will evaluate the prevention of bacteremic infections in End Stage Renal Disease (ESRD) patients during the interval between 3 and 35 weeks after a single dose of StaphVAX. Part B of this study is designed to assess immunogenicity of a second \[booster\] dose of vaccine in patients completing Part A, and the cumulative (Part A + B) efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,600
Documented S. aureus invasive infection, weeks 3-35
Documented S. aureus invasive infection in other time periods
Immunogenicity at mulitple time points
Safety
Health economics
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