drugset / Trial / NCT00211913

StaphVAX in Cardiovascular Surgery Patients

NCT00211913 ↗

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

Summary

S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.

Timeline

Start
2004-06
Primary completion
2005-10
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate Unknown 200 ug Intramuscular