Status:
TERMINATED
Evaluation of a Third and Fourth Dose of StaphVAX® in Adults With End-Stage Renal Disease
Lead Sponsor:
Nabi Biopharmaceuticals
Conditions:
Staphylococcal Infections
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a continued evaluation of the immune response to StaphVAX , a Staphylococcus aureus type 5 and 8 capsular polysaccharide conjugate vaccine, in end-stage renal disease patients, by giving...
Eligibility Criteria
Inclusion
- Participation in prior study Nabi-1371
- Written informed consent
- Negative serum pregnancy test, where appropriate
- 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 2 months prior to injection
- Hypersensitivity to components of StaphVAX
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00130260
Start Date
August 1 2005
End Date
April 1 2006
Last Update
January 4 2008
Active Locations (1)
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1
multiple sites: contact Central Study coordination
Birmingham, Alabama, United States