ClinicalTrials.gov record
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
ClinicalTrials.gov ID: NCT02388165
Public ClinicalTrials.gov record NCT02388165. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02388165
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 3,450 participants
Conditions and interventions
Conditions
Interventions
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine Biological
- Placebo Other
Biological · Other
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2, 2015 (Actual)
- Primary completion
- Jun 26, 2019 (Actual)
- Completion
- Jun 27, 2019 (Actual)
- Last update posted
- Jan 5, 2021
2015 – 2019
United States locations
- U.S. sites
- 234
- U.S. states
- 29
- U.S. cities
- 92
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Barrow Brain and Spine | Phoenix | Arizona | 85013 | — |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Greenbaum Surgical Specialty Hospital | Scottsdale | Arizona | 85251 | — |
| HonorHealth Scottsdale Osborn Medical Center | Scottsdale | Arizona | 85251 | — |
| Clinical Office - Jason Cuellar M.D. | Beverly Hills | California | 90210 | — |
| Memorial Orthopaedic Surgical Group | Long Beach | California | 90806 | — |
| IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | 90033 | — |
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| USC Spine Center | Los Angeles | California | 90033 | — |
| USC/Department of Neurological Surgery | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center - Investigational Drug | Los Angeles | California | 90048 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Clinical Office | Los Angeles | California | 90048 | — |
| The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| Ronald Reagan Med Center - University of California, Los Angeles (UCLA) | Los Angeles | California | 90095 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| UCLA CTRC Outpatient Unit | Los Angeles | California | 90095 | — |
| Kaiser Permanente Pediatric Clinic | Oakland | California | 94611 | — |
| Kaiser Permanente Vaccine Study Center | Oakland | California | 94612 | — |
| University of California Irvine Medical Center | Orange | California | 92868 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| UCLA Spine Center | Santa Monica | California | 90401 | — |
| Santa Monica UCLA Medical Center & Orthopaedic Hospital | Santa Monica | California | 90404 | — |
| UCLA Santa Monica Infectious Disease | Santa Monica | California | 90404 | — |
| LA BioMed at Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| LA BioMed, Harbor-UCLA Medical Center | Torrance | California | 90502 | — |
| Harbor-UCLA Medical Center | Torrance | California | 90509 | — |
| LA BioMed at Harbor-UCLA Medical Center | Torrance | California | 90509 | — |
| University of Colorado Clinical & Translational Research Center Clinic | Aurora | Colorado | 80045 | — |
| University of Colorado Denver, School of Medicine | Aurora | Colorado | 80045 | — |
| University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| Boulder Community Health - Foothills Hospital | Boulder | Colorado | 80303 | — |
| Boulder Community Health | Boulder | Colorado | 80303 | — |
| Justin Parker Neurological Institute | Boulder | Colorado | 80303 | — |
| University of Colorado Hospital, Lone Tree Health Center | Lone Tree | Colorado | 80124 | — |
| Yale New Haven Hospital - Investigational Drug Services | New Haven | Connecticut | 06510 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Yale New Haven Hospital - St. Raphael campus | New Haven | Connecticut | 06511 | — |
| Ycci-Csru | New Haven | Connecticut | 06519 | — |
| Yale-New Haven Hospital Spine Center | New Haven | Connecticut | 06878 | — |
| Holmes Regional Medical Center | Melbourne | Florida | 32901 | — |
| The B.A.C.K. Center | Melbourne | Florida | 32901 | — |
| Melbourne Regional Medical Center | Melbourne | Florida | 32935 | — |
| University of Miami Hospital and Clinics and Research Pharmacy | Miami | Florida | 33136 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Florida Hospital Orlando | Orlando | Florida | 32803 | — |
| Neuroscience ACS Research | Orlando | Florida | 32803 | — |
| Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy | Orlando | Florida | 32804 | — |
| Gulfcoast Research Institute, LLC | Sarasota | Florida | 34232 | — |
| Emory University Clinic | Atlanta | Georgia | 30322 | — |
| Emory Orthopaedics & Spine Center | Atlanta | Georgia | 30329 | — |
| Emory Orthopaedics & Spine Hospital | Tucker | Georgia | 30084 | — |
| Bingham Memorial Hospital | Blackfoot | Idaho | 83221 | — |
| Bingham Memorial Specialty Clinic | Idaho Falls | Idaho | 83404 | — |
| Brent H. Greenwald, M.D. Neurological Surgery | Idaho Falls | Idaho | 83404 | — |
| Eastern Idaho Regional Medical Center | Idaho Falls | Idaho | 83404 | — |
| Mountain View Hospital | Idaho Falls | Idaho | 83404 | — |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | — |
| Physicians & Surgeons Clinic | Pocatello | Idaho | 83201 | — |
| Bingham Memorial Family Medicine & Specialty Clinic | Pocatello | Idaho | 83202 | — |
| University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services | Chicago | Illinois | 60612-4333 | — |
| University of Illinois Hospital and Health Sciences System | Chicago | Illinois | 60612-7232 | — |
| Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC) | Chicago | Illinois | 60612 | — |
| Rush University Medical Center Pharmacy | Chicago | Illinois | 60612 | — |
| Rush University Medical Center Professional Office Building Infusion Pharmacy | Chicago | Illinois | 60612 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66103 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Norton Healthcare Pharmacy | Louisville | Kentucky | 40202 | — |
| Norton Hospital | Louisville | Kentucky | 40202 | — |
| Norton Leatherman Spine Center | Louisville | Kentucky | 40202 | — |
| Ochsner Baptist Medical Center | New Orleans | Louisiana | 70115 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Spine Institute of Louisiana | Shreveport | Louisiana | 71101-4643 | — |
| AAMC Research Pharmacy | Annapolis | Maryland | 21401 | — |
| Anne Arundel Health System Research Institute (AAHSRI) | Annapolis | Maryland | 21401 | — |
| Anne Arundel Medical Center Infusion Center | Annapolis | Maryland | 21401 | — |
| Anne Arundel Medical Center Laboratory | Annapolis | Maryland | 21401 | — |
| Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Annapolis | Maryland | 21401 | — |
| University of Maryland Medical Systems, Department of Neurosurgery | Baltimore | Maryland | 21201 | — |
| University of Maryland Medical Systems, Investigational Drug Services | Baltimore | Maryland | 21201 | — |
| University of Maryland, Medical Systems, Oriole Park | Baltimore | Maryland | 21201 | — |
| John Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | — |
| Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center | Baltimore | Maryland | 21287 | — |
| John Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| The Johns Hopkins Hospital Investigational Drug Service | Baltimore | Maryland | 21287 | — |
| Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Bowie | Maryland | 20716 | — |
| Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Odenton | Maryland | 21113 | — |
| Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Pasadena | Maryland | 21122 | — |
| Massachusetts General Hospital, Clinical Research Pharmacy | Boston | Massachusetts | 02114 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital Investigational Drug Services (IDS) | Boston | Massachusetts | 02115 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| UMass Memorial Medical Center- Clinical Research Center | Worcester | Massachusetts | 01605 | — |
| UMass Memorial Medical Center | Worcester | Massachusetts | 01605 | — |
| University of Massachusetts Medical Center Memorial Campus | Worcester | Massachusetts | 01605 | — |
| University of Michigan Investigational Pharmacy | Ann Arbor | Michigan | 48109-5008 | — |
| University Of Michigan Hospitals | Ann Arbor | Michigan | 48109-5338 | — |
| Detroit Receiving Hospital, Heart Hospital, Harper Hospital at | Detroit | Michigan | 48201 | — |
| Butterworth Hospital | Grand Rapids | Michigan | 49503 | — |
| Blodgett Hospital | Grand Rapids | Michigan | 49506 | — |
| Orthopaedic Associates of Michigan - Research | Grand Rapids | Michigan | 49525 | — |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | — |
| Bronson Spine and Scoliosis Specialists | Kalamazoo | Michigan | 49007 | — |
| Michigan Orthopaedic & Spine Surgeons | Rochester Hills | Michigan | 48307 | — |
| Beaumont Orthopaedic Center | Royal Oak | Michigan | 48073 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Michigan Orthopaedic Institute | Southfield | Michigan | 48033 | — |
| Beaumont Health-Troy | Troy | Michigan | 48085 | — |
| Michigan Orthopaedic Institute | West Bloomfield | Michigan | 48322 | — |
| Twin Cities Spine Surgeons dba Twin Cities Spine Center | Minneapolis | Minnesota | 55404 | — |
| Allina Health - Abbott Northwestern Hospital / | Minneapolis | Minnesota | 55407 | — |
| Mayo Clinic Hospital, Methodist Campus | Rochester | Minnesota | 55902 | — |
| Mayo Clinic Rochester, Methodist Hospital Campus | Rochester | Minnesota | 55902 | — |
| Mayo Clinic Hospital, Methodist Campus | Rochester | Minnesota | 55905 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Center for Outpatient Health | St Louis | Missouri | 63108 | — |
| Barnes Jewish Center for Advanced Medicine | St Louis | Missouri | 63110 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Barnes Jewish Pharmacy | St Louis | Missouri | 63110 | — |
| Barnes-Jewish Pharmacy | St Louis | Missouri | 63110 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| University Medical Center of Southern Nevada | Las Vegas | Nevada | 89102 | — |
| The Rothman Institute Marlton, NJ Office | Marlton | New Jersey | 08053 | — |
| HackensackUMC Mountainside Hospital | Montclair | New Jersey | 07042 | — |
| Meridian Hospitals Corp c/o Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| Ambulatory Care Center | Newark | New Jersey | 07103 | — |
| Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School | Newark | New Jersey | 07103 | — |
| University Hospital - Pharmacy | Newark | New Jersey | 07103 | — |
| University Hospital | Newark | New Jersey | 07103 | — |
| The Rothman Institute Washington Township, NJ Office | Sewell | New Jersey | 08080 | — |
| Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck | Great Neck | New York | 11021 | — |
| NYU Langone Huntington Medical Group | Huntington Station | New York | 11746 | — |
| UHS Neurosurgery | Johnson City | New York | 13790 | — |
| UHS Wilson Medical Center | Johnson City | New York | 13790 | — |
| Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook | Lynbrook | New York | 11563 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| The Feinstein Institute for Medical Research | Manhasset | New York | 11030 | — |
| NYU Langone Health Orthopedic Hospital | New York | New York | 10003 | — |
| Kimmel Pavillion | New York | New York | 10016 | — |
| NYU Langone Health Orthopedic Center | New York | New York | 10016 | — |
| NYU Langone Health Tisch Hospital | New York | New York | 10016 | — |
| NYU Langone Madison Ave. Orthopedics | New York | New York | 10016 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| lcahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| The Clinical Research Unit at Mount Sinai | New York | New York | 10029 | — |
| NYU Langone Seaport Orthopaedics | New York | New York | 10279 | — |
| Carolina Neurosurgery and Spine Associates, P.A. | Charlotte | North Carolina | 28204 | — |
| Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital | Charlotte | North Carolina | 28207 | — |
| OrthoCarolina Hip & Knee Center | Charlotte | North Carolina | 28207 | — |
| OrthoCarolina | Charlotte | North Carolina | 28207 | — |
| OrthoCarolina Pineville | Charlotte | North Carolina | 28210 | — |
| OrthoCarolina Ballantyne | Charlotte | North Carolina | 28277 | — |
| Duke University Hospital, IDS Pharmacy | Durham | North Carolina | 27710 | — |
| Duke University Hospital | Durham | North Carolina | 27710 | — |
| OrthoCarolina Matthews | Matthews | North Carolina | 28105 | — |
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation - Investigation Pharmacy | Cleveland | Ohio | 44195 | — |
| Cleveland Clinic Foundation Center for Spine Health | Cleveland | Ohio | 44195 | — |
| Riverside Methodist Hospital Pharmacy | Columbus | Ohio | 43214 | — |
| Remington-Davis, Inc. | Columbus | Ohio | 43215 | — |
| Orthopedic One | Columbus | Ohio | 43220 | — |
| Dublin Methodist Hospital | Dublin | Ohio | 43016 | — |
| OHSU Research Pharmacy | Portland | Oregon | 97239 | — |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | — |
| Abington Jefferson Health-Pharmacy Department | Abington | Pennsylvania | 19001 | — |
| Abington Jefferson Health | Abington | Pennsylvania | 19001 | — |
| Rothman Institute-Chalfont Office | Chalfont | Pennsylvania | 18914 | — |
| Milton S. Hershey Medical Center Pharmacy | Hershey | Pennsylvania | 17033 | — |
| Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Investigational Drug Service Pharmacy | Philadelphia | Pennsylvania | 19107 | — |
| Jefferson Hospital For Neuroscience | Philadelphia | Pennsylvania | 19107 | — |
| The Rothman Institute | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University Hospital - Pre-Admission Testing Center | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University Hospital, Cardiovascular Associates | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Upmc (Puh/Muh) | Pittsburgh | Pennsylvania | 15213 | — |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| Rothman Institute-Willow Grove Office | Willow Grove | Pennsylvania | 19090 | — |
| Dell Seton Medical Center at The University of Texas | Austin | Texas | 78701 | — |
| Austin Infectious Disease Consultants | Austin | Texas | 78705 | — |
| Employee Wellness Center | Austin | Texas | 78705 | — |
| Seton Medical Center Austin | Austin | Texas | 78705 | — |
| St. David's Medical Center | Austin | Texas | 78705 | — |
| St. David's Neuroscience and Spine Institute | Austin | Texas | 78705 | — |
| Seton Spine and Scoliosis Center | Austin | Texas | 78731 | — |
| St. David's North Austin Medical Center | Austin | Texas | 78758 | — |
| Wellness Brain and Spine | Austin | Texas | 78758 | — |
| Neurosurgical Specialist of Texas | Fredericksburg | Texas | 78624 | — |
| Hermann Drive Surgical Hospital | Houston | Texas | 77004 | — |
| Mermorial Hermann - Memorial City Medical Center | Houston | Texas | 77024 | — |
| Baylor College of Medicine - McNair Campus | Houston | Texas | 77030 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas | 77030 | — |
| Baylor Scott & White Medical Center | Plano | Texas | 75093 | — |
| Seton Brain and Spine Institute Williamson | Round Rock | Texas | 78665 | — |
| Seton Medical Center Williamson | Round Rock | Texas | 78665 | — |
| St. David's Round Rock Medical Center | Round Rock | Texas | 78681 | — |
| Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute) | Temple | Texas | 76508 | — |
| Scott & White Memorial Hospital and Clinic | Temple | Texas | 76508 | — |
| Scott & White Memorial Hospital | Temple | Texas | 76508 | — |
| Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia | 22003 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | — |
| Inova Medical Group | Fairfax | Virginia | 22031 | — |
| Inova Fair Oaks Hospital | Fairfax | Virginia | 22033 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Inova Neurosciences Research | Falls Church | Virginia | 22042 | — |
| OrthoVirginia | McLean | Virginia | 22102 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Sentara Medical Group DBA Sentara Neurosurgery Specialists | Norfolk | Virginia | 23510 | — |
| VCU Medical Center Investigational Drug Service | Richamond | Virginia | 23298-5028 | — |
| VCU Heatlh Neuroscience Orthopedic and Wellness Center | Richmond | Virginia | 23233 | — |
| VCU Health Ambulatory Care Center | Richmond | Virginia | 23298 | — |
| VCU Health | Richmond | Virginia | 23298 | — |
| Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S) | Roanoke | Virginia | 24014 | — |
| Carilion Clinic - Department of Pharmacy | Roanoke | Virginia | 24014 | — |
| Carilion Clinic Institute for Orthopaedics and Neurosciences | Roanoke | Virginia | 24014 | — |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | — |
| Carilion Clinic Riverside 3 | Roanoke | Virginia | 24016 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| WVU Medicine Spine Center | Morgantown | West Virginia | 26505 | — |
| WVU Medicine JW Ruby Memorial Hospital | Morgantown | West Virginia | 26506-9196 | — |
| WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy | Morgantown | West Virginia | 26506 | — |
| WVU Medicine Physician Office Center Orthopaedic Surgery | Morgantown | West Virginia | 26506 | — |
| WVU Medicine Physician Office Center | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02388165, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 5, 2021 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02388165 live on ClinicalTrials.gov.