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Sponsored by: |
Nabi Biopharmaceuticals |
Information provided by: | Nabi Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00211926 |
S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.
Condition | Intervention | Phase |
Staphylococcal Infections Joint Prosthesis |
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate Biological: placebo |
Phase III |
MedlinePlus related topics: | Staphylococcal Infections |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant |
Enrollment: | 120 |
Study Start Date: | December 2004 |
Study Completion Date: | October 2006 |
Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
StaphVAX: Experimental |
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single dose of vaccine containing 100 mcg of each serotype conjugate
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Placebo: Placebo Comparator |
Biological: placebo
single dose of placebo
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Virginia | |||||
Cllinical Research Asociates of Tidewater | |||||
Norfolk, Virginia, United States, 23507 |
Nabi Biopharmaceuticals |
Study Director: | Preston Holley, MD | Nabi Biopharmaceuticals |
Responsible Party: | Nabi Biopharmaceuticals ( Matt Hohenboken, MD, PhD/ Executive Director Clinical and Medical Affairs ) |
Study ID Numbers: | Nabi-1365 |
First Received: | September 13, 2005 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00211926 |
Health Authority: | United States: Food and Drug Administration |
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