- 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
- 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