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

Last updated on June 14, 2019

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Study Location
The University of Alabama at Birmingham
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Staphylococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT02388165
Pfizer
Active, not recruiting
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

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[email protected]

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