drugset / Trial / NCT00211926

StaphVAX Immunogenicity in Orthopedic Implant Patients

NCT00211926 ↗

Phase 3 Completed 120 enrolled Nabi Biopharmaceuticals
RandomizedParallel-groupQuadruple-blindPrevention

Summary

S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.

Timeline

Start
2004-12
Primary completion
2006-06
Completion
2006-10

Drugs

EvaluationDrugModalityDoseRoute
Subject S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate Unknown 100 ug —