Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
NCT02388165
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation | ||||||
Official Title ICMJE | 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 | ||||||
Brief 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Prevention | ||||||
Condition ICMJE | Staphylococcal Vaccine | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 3450 | ||||||
Original Estimated Enrollment ICMJE | 2600 | ||||||
Actual Study Completion Date ICMJE | June 27, 2019 | ||||||
Actual Primary Completion Date | June 26, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Austria, Bulgaria, Canada, France, Germany, Hungary, Japan, Spain, Sweden, United Kingdom, United States | ||||||
Removed Location Countries | Romania | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02388165 | ||||||
Other Study ID Numbers ICMJE | B3451002 2014-002644-40 ( EudraCT Number ) 6123K1-2001 ( Other Identifier: Alias Study Number ) STRIVE ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | November 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |