Evaluation of Consistency of StaphVAX Manufacturing Lots

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. The antibodies in the blood measure the immunogenicity of each lot of vaccine, and typical vaccine safety information is also collected.

Timeline

Start

2005-04

Primary completion

2005-07

Completion

2005-07

Publications

• Creech CB 2nd, Johnson BG, Alsentzer AR, Hohenboken M, Edwards KM, Talbot TR 3rd. Vaccination as infection control: a pilot study to determine the impact of Staphylococcus aureus vaccination on nasal carriage. Vaccine. 2009 Dec 10;28(1):256-60. doi: 10.1016/j.vaccine.2009.09.088. Epub 2009 Sep 30.

Drugs

Indications