NCT00071214

Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,600 (planned)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Two part study testing the effectiveness and safety of StaphVAX vaccine in chronic hemodialysis patients against infection by Staphylococcus aureus.

Detailed description

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.

Conditions

• Staphylococcal Infections
• Kidney Failure, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	S. aureus Type 5 and 8 Capsular Polysaccharide Conjugate Vaccine

Timeline

• Start date: 2003-09-01
• Completion: 2005-09-01
• First posted: 2003-10-17
• Last updated: 2006-07-11