Status:
COMPLETED
StaphVAX in Cardiovascular Surgery Patients
Lead Sponsor:
Nabi Biopharmaceuticals
Conditions:
Staphylococcal Infections
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 poly...
Eligibility Criteria
Inclusion
- Candidate for cardiovascular surgery
- Expected to comply with protocol
- Negative pregnancy test where appropriate
- Written informed consent
Exclusion
- Known S. aureus infection in past 3 months
- Known infection in the past 2 weeks
- Known HIV infection
- Pregnancy or breast-feeding
- Immunomodulatory drugs
- Malignancy or treatment for malignancy within the past six months, other than basal cell, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or early stage prostate cancer
- investigational drugs, vaccines or products in the past 30 days
- Hypersensitivity to components of StaphVAX
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00211913
Start Date
June 1 2004
End Date
January 1 2006
Last Update
January 4 2008
Active Locations (1)
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1
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507