Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.
Kidney Failure, Chronic
Biological: S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Efficacy of StaphVAX, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis|
- Documented S. aureus invasive infection, weeks 3-35
- Documented S. aureus invasive infection in other time periods
- Immunogenicity at mulitple time points
- Health economics
|Study Start Date:||September 2003|
|Estimated Study Completion Date:||September 2005|
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.