Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 2/28/2019 |
Start Date: | July 2, 2015 |
End Date: | June 26, 2019 |
A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF STAPHYLOCOCCUS AUREUS 4 ANTIGEN VACCINE (SA4AG) IN ADULTS UNDERGOING ELECTIVE OPEN POSTERIOR SPINAL FUSION PROCEDURES WITH MULTILEVEL INSTRUMENTATION
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent
postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal
fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective
spinal surgery.
postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal
fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective
spinal surgery.
Inclusion Criteria:
- Subject must be scheduled to undergo an elective open posterior spinal fusion
procedures with multilevel instrumentation, 10 to 60 days after study vaccination.
- Subject must be available for the entire duration of the study, and able to comply
with scheduled visits, treatment plan, laboratory tests, and other study procedures
including completion of the electronic diary for 10 days after study vaccination.
- Aged 18 to <86 years old
Exclusion Criteria:
- Planned spinal fusion procedure requiring separate operations performed on separate
days (ie, staged procedure).
- Surgical indication of malignancy, infection or acute or emergency trauma.
- History of major surgery within 3 months prior to enrollment, or anticipated major
surgery other than the Index Surgical Procedure between study enrollment and
completion of study participation.
- History of any spinal surgery performed within 6 months prior to study enrollment.
- History of any previous spinal surgery resulting in postoperative BSI or SSI.
- Congenital or acquired immunodeficiency disorder, rheumatologic disorder or other
illness requiring chronic treatment with known immunosuppressant medications,
including monoclonal antibodies within a year of enrollment or the use of systemic
corticosteroids for > 14 days within 30 days prior to enrollment.
- History of leukemia, lymphoma, underlying bone marrow disorder or history of bone
marrow transplant.
We found this trial at
233
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Annandale, Virginia 22003
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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55 Fruit Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
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45 Francis Street
Boston, Massachusetts 02115
Boston, Massachusetts 02115
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Charlotte, North Carolina 28207
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University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1740 West Taylor Street
Chicago, Illinois 60612
Chicago, Illinois 60612
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Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC)
1653 W Congress Pkwy
Chicago, Illinois 60612
Chicago, Illinois 60612
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The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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900 Northern Boulevard
Great Neck, New York 11021
Great Neck, New York 11021
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Hershey, Pennsylvania 17033
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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