Status:
COMPLETED
StaphVAX Immunogenicity in Orthopedic Implant Patients
Lead Sponsor:
Nabi Biopharmaceuticals
Conditions:
Staphylococcal Infections
Joint Prosthesis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- age 18 years or older
- candidate for knee or hip replacement
- expectation of protocol compliance
- negative pregnancy test, where appropriate
Exclusion
- known S. aureus infection in the prior 3 months
- infection in the prior 2 weeks
- Known HIV infection
- immunomodulatory drugs
- Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
- Hypersensitivity to components of StaphVAX
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00211926
Start Date
December 1 2004
End Date
October 1 2006
Last Update
January 4 2008
Active Locations (1)
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1
Cllinical Research Asociates of Tidewater
Norfolk, Virginia, United States, 23507