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Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Posterior Instrumented Lumbar Spinal Fusion Procedure (STRIVE)
Overall Recruitment Status: Active, enrollment completed
 
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 Posterior Instrumented Lumbar Spinal Fusion Procedures
 
Region Sponsors
California - Northern
Pfizer
 
Acronym KP IRB No.
STRIVE CN-15-2210-B
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Male & Female 18 - 85 years
 
Inclusion Criteria
  • Subject must be scheduled to undergo an elective posterior instrumented lumbar spinal fusion procedure 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.
 
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.

 
Keywords and/or Specific Medical Conditions
  • MRSA
  • Infectious Diseases
  • Post-operative Surgical Site Infection
  • Staphylococcal Vaccine
  • Spinal Surgery
  • Surgery (Orthopedic)
  • Staphylococcus aureus
 
KP Clinical Facility
  • Oakland Medical Center
 
Clinical Area
  • Infectious Diseases
  • Surgery (Orthopedic)


Principal Investigator:
Nicola Klein
Contact Information:


smilelady1
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