NCT00211900

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Nabi Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Staphylococcal Infections
• Chronic Kidney Failure

Interventions

Type	Name	Description
BIOLOGICAL	S. aureus Type 5 & 8 Capsular Polysaccharide Vaccine	single IM dose totalling 200 mcg of conjugate

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-08-01
• Completion: 2005-11-01
• First posted: 2005-09-21
• Last updated: 2008-01-04

Locations

1 site across 1 country: United States