Summary

for people ages 18-85 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Sibel Deviren

Description

Summary

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.

Official Title

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study To Evaluate The Safety And Efficacy Of Staphylococcus Aureus 4 Antigen Vaccine (sa4ag) In Adults Undergoing Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation

Keywords

Staphylococcal Vaccine Post-operative Surgical Site Infection Spinal Surgery MRSA Staphylococcus aureus Vaccines Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine

Eligibility

You can join if…

Open to people ages 18-85

  • 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 CAN'T join 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.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Kaiser Permanente Vaccine Study Center accepting new patients
    Oakland California 94612 United States
  • Kaiser Permanente Pediatric Clinic accepting new patients
    Oakland California 94611 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02388165
Phase
Phase 2
Lead Scientist
Sibel Deviren
Study Type
Interventional
Last Updated
September 7, 2018