Status:
COMPLETED
StaphVAX Immunogenicity and Safety in Orthopaedic Joint Surgery
Lead Sponsor:
Nabi Biopharmaceuticals
Collaborating Sponsors:
Public Health England
Conditions:
Staphylococcal Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Staphylococcus aureus (S. aureus) is the most common pathogen encountered in infections associated with orthopedic surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the p...
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 prostate cancer)
- Hypersensitivity to components of StaphVAX
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00211965
Start Date
April 1 2005
End Date
August 1 2006
Last Update
January 4 2008
Active Locations (1)
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1
National Royal Orthopaedic Hospital
Stanmore, Middlesex, United Kingdom, HA7 4LP