Clinical Trials

Inclusion Criteria:

• Subject must personally sign and date the informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
• Subject must be aged 18 to <86 years at the time of enrollment.
• Subject must be scheduled to undergo an elective open posterior spinal fusion procedure with multilevel instrumentation 10 to 60 days after study vaccination.
• Subject must be available for the entire duration of the study, and willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, including completion of the electronic diary (e-diary) for 10 days after study vaccination (If surgery occurs on Day 10, then the e-diary does not need to be completed for that day).
• Subject must be able to be contacted by telephone during study participation.
• Male subjects and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

• Planned spinal fusion procedure requiring separate operations performed on separate days (i.e., staged procedure).
• Single-level spinal fusions without insertion of multilevel instrumentation (i.e., surgical implantation of prosthetic material involving 2 or more motion segments).
• Surgical indication of malignancy, infection, or acute or emergency trauma (i.e., related to a traumatic incident occurring within 6 months prior to study enrollment).
• History of major surgery (specifically, an open procedure that enters a body cavity, organ, or joint space) 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, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrollment or the use of systemic corticosteroids (equivalent of 10 mg/day of prednisone) for >14 days within 30 days prior to study enrollment.
• History of leukemia, lymphoma, or underlying bone marrow disorder (e.g., myelodysplasia, myeloma, myeloproliferative disorder) or history of bone marrow transplant.
• Malignancy that required treatment with chemotherapy, immunotherapy, radiation therapy, or other antineoplastic target therapies within 24 months prior to study enrollment.
• Any known or suspected malignancy to the spine.
• Congenital, functional, or surgical asplenia.
• End-stage renal disease (defined as requiring or anticipating requirement for hemodialysis, peritoneal dialysis, or renal transplant) or nephrotic syndrome.
• Any contraindication to vaccination or vaccine components, including history of anaphylactic reaction to any vaccine or vaccine-related component.
• Receipt of blood products or immunoglobulins (including monoclonal antibodies) within 6 months prior to study enrollment OR anticipated receipt of blood products or immunoglobulins (including monoclonal antibodies) prior to the index hospital admission.
• Previous administration of S aureus vaccine or S aureus/Candida vaccine.
• Antibiotic therapy for microbiologically confirmed ISA disease within 12 months prior to enrollment.
• Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or anticipated participation during the study.
• Pregnant females, breastfeeding females, and males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception, as outlined in Section 4.4, for the duration of the study.
• Presence of a colostomy, urostomy, tracheostomy, percutaneous gastrostomy tube, indwelling vascular or urinary catheter, central nervous system shunt, central nervous system implanted device, or spinal cord stimulator; OR anticipated presence of a colostomy, urostomy, tracheostomy, percutaneous gastrostomy tube, indwelling vascular or urinary catheter, central nervous system shunt, central nervous system implanted device, or spinal cord stimulator prior to the index hospital admission.
• Other severe acute or chronic medical or psychiatric condition (including drug and alcohol dependencies) or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.

• 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.