Status:
COMPLETED
Evaluation of Manufacturing Lot of StaphVAX
Lead Sponsor:
Nabi Biopharmaceuticals
Conditions:
Staphylococcal Infections
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study answers a U.S. Food and Drug Administration requirement for evaluation in people of a manufacturing lot of vaccine. Subjects receive one dose of one lot of vaccine. The antibodies in the bl...
Eligibility Criteria
Inclusion
- 8 wk of hemodialysis for ESRD,
- have written informed consent,
- a negative serum pregnancy test if appropriate,
- and expect to comply with protocol procedures and schedule
Exclusion
- known HIV,
- immunomodulatory drugs,
- malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer),
- active infection in the 2 weeks prior to study injection,
- serious S. aureus infection within the last 3 months prior to injection,
- use of investigational drugs, vaccines or devices within the prior 30 days,
- hypersensitivity to components of StaphVAX
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00211900
Start Date
March 1 2005
End Date
November 1 2005
Last Update
January 4 2008
Active Locations (1)
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1
Trialogic Research
Madison, Alabama, United States, 35758