Status:
COMPLETED
Evaluation of Consistency of StaphVAX Manufacturing Lots
Lead Sponsor:
Nabi Biopharmaceuticals
Collaborating Sponsors:
Vanderbilt University
Conditions:
Staphylococcal Infections
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 the consistency of manufacturing of a vaccine. Subjects are randomized to one of three lots of vaccine. T...
Eligibility Criteria
Inclusion
- healthy,
- written informed consent,
- negative serum pregnancy test if 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 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 :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT00211991
Start Date
April 1 2005
End Date
July 1 2005
Last Update
May 14 2012
Active Locations (1)
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1
Vanderbuilt University
Nashville, Tennessee, United States, 37232