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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Staphylococcal Vaccine

Treatments: Other: Placebo; Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02388165

2014-002644-40 (EudraCT Number)

B3451002

6123K1-2001 (Other Identifier)

STRIVE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3,450 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,450 participants in 2 patient groups, including a placebo group

SA4Ag

Active Comparator group

Description:

Staphylococcus aureus 4-antigen Vaccine

Treatment:

Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine

Placebo

Placebo Comparator group

Description:

Diluent (sterile water) for Placebo

Treatment:

Other: Placebo