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Sponsored by: |
Nabi Biopharmaceuticals |
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Information provided by: | Nabi Biopharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00211913 |
S. aureus is the most common pathogen encountered in infection associated with cardiovascular surgery. StaphVAX® is a bivalent S. aureus types 5 and 8 vaccine which contains the purified capsular polysaccharides (CPS) that have been implicated as a major factor in the invasiveness of S. aureus. Immunoprophylaxis by vaccinating against S. aureus prior to surgery could provide sufficient antibody concentrations during surgery and during the wound healing period so as to decrease the risk of S. aureus infection. This study aims to demonstrate the immunogenicity and safety of a single dose of StaphVAX in patients who are candidates for cardiovascular surgery.
Condition | Intervention | Phase |
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Staphylococcal Infections Cardiovascular Diseases Cardiovascular Surgical Procedures |
Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate Biological: placebo |
Phase III |
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 Undergoing Cardiovascular Surgery |
Enrollment: | 120 |
Study Start Date: | June 2004 |
Study Completion Date: | January 2006 |
Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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vaccine: Experimental
single dose of StaphVAX®
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Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
single IM dose totalling 200 mcg of conjugate
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placebo: Placebo Comparator
single dose
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Biological: placebo
single IM dose
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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 | |
Clinical Research Associates of Tidewater | |
Norfolk, Virginia, United States, 23507 |
Study Director: | Preston Holley, MD | Nabi Biopharmaceuticals |
Responsible Party: | Nai Biopharmaceuticals ( Matt Hohenboken, MD, PhD, Executive Director Clinical & Medical Affairs ) |
Study ID Numbers: | Nabi-1366 |
Study First Received: | September 13, 2005 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00211913 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Cardiovascular Diseases Infection |