Evaluation of Manufacturing Lot of StaphVAX

Completed · Phase 3

Conditions studied: Staphylococcal Infections, Chronic Kidney Failure

In brief

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 blood measure the immunogenicity of the vaccine, and typical vaccine safety information is also collected.

Key facts

Study ID

NCT00211900

Run by

Nabi Biopharmaceuticals

People needed

65

Starts

2005-03-01

Expected to finish

2005-11-01

Last updated by the study team

2008-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Trialogic Research — Madison, Alabama, United States

Full record on ClinicalTrials.gov

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