Evaluation of Consistency of StaphVAX Manufacturing Lots
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.
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Compare Immunogenicity and Safety Between Three Commercial Lots of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine in Normal, Healthy, Adult Volunteers|
- Type-specific antibody concentrations 6 weeks after vaccine dose.
- Antibody concentrations at other time points.
- Elicited health events.
|Study Start Date:||April 2005|
|Study Completion Date:||July 2005|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Study Director:||Matt Hohenboken, MD, PhD||Nabi Biopharmaceuticals|