Evaluation of Manufacturing Lot of StaphVAX

A Phase 3, Multicenter, Open-Label, Historical Comparative Study to Evaluate Immunogenicity and Safety of a Commercial Lot of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Adults on Hemodialysis

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.

Inclusion Criteria:

• 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 Criteria:

• 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