Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Staphylococcal Vaccine

In brief

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.

Key facts

Study ID

NCT02388165

Run by

Pfizer

People needed

3450

Starts

2015-07-02

Expected to finish

2019-06-27

Last updated by the study team

2021-01-05

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Barrow Brain and Spine — Phoenix, Arizona, United States
• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Greenbaum Surgical Specialty Hospital — Scottsdale, Arizona, United States
• HonorHealth Scottsdale Osborn Medical Center — Scottsdale, Arizona, United States
• Clinical Office - Jason Cuellar M.D. — Beverly Hills, California, United States
• Memorial Orthopaedic Surgical Group — Long Beach, California, United States
• IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• USC Spine Center — Los Angeles, California, United States
• USC/Department of Neurological Surgery — Los Angeles, California, United States
• Cedars-Sinai Medical Center - Investigational Drug — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Clinical Office — Los Angeles, California, United States
• The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center — Los Angeles, California, United States
• Ronald Reagan Med Center - University of California, Los Angeles (UCLA) — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA CTRC Outpatient Unit — Los Angeles, California, United States
• Kaiser Permanente Pediatric Clinic — Oakland, California, United States
• Kaiser Permanente Vaccine Study Center — Oakland, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• University of California, San Francisco — San Francisco, California, United States
• UCLA Spine Center — Santa Monica, California, United States
• Santa Monica UCLA Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
• UCLA Santa Monica Infectious Disease — Santa Monica, California, United States
• The University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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