NCT00211926

StaphVAX Immunogenicity in Orthopedic Implant Patients

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Staphylococcal Infections
• Joint Prosthesis

Interventions

Type	Name	Description
BIOLOGICAL	S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate	single dose of vaccine containing 100 mcg of each serotype conjugate
BIOLOGICAL	placebo	single dose of placebo

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-06-01
• Completion: 2006-10-01
• First posted: 2005-09-21
• Last updated: 2008-01-04

Locations

1 site across 1 country: United States