drugset / Trial / NCT00211900

Evaluation of Manufacturing Lot of StaphVAX

NCT00211900 ↗

Phase 3 Completed 65 enrolled Nabi Biopharmaceuticals
Non-randomizedSingle-groupOpen-labelPrevention

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.

Timeline

Start
2005-03
Primary completion
2005-08
Completion
2005-11

Drugs

EvaluationDrugModalityDoseRoute
Subject StaphVAX Vaccine 200 ug Intramuscular