Clinical trial NCT02388165: Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Staphylococcal Vaccine
Keywords: Staphylococcal Vaccine
Post-operative Surgical Site Infection
Spinal Surgery
MRSA
Staphylococcus aureus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 3450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery
timeFrame: Day of surgery (Day 1) up to Day 90
measure: Percentage of Participants With Local Reactions Within 10 Days After Vaccination
timeFrame: Within 10 days after Vaccination
measure: Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination
timeFrame: Within 10 days after Vaccination
measure: Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1)
timeFrame: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)
measure: Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42
timeFrame: From vaccination until Day 42 after surgery (52-102 days after vaccination)
measure: Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42
timeFrame: Day of surgery (Day 1) up to Day 42 after surgery
measure: Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180
timeFrame: Day 42 up to Day 180 (up to 138 days)
measure: Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180
timeFrame: From vaccination up to Day 180 after surgery (190-240 days after vaccination)
measure: Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1)
timeFrame: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)
measure: Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180
timeFrame: Day of surgery (Day 1) up to Day 180 after surgery
Secondary outcomes:
measure: Number of Participants With Postoperative S. Aureus Blood Stream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery
timeFrame: Day of surgery (Day 1) up to Day 180 after surgery
measure: Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery
timeFrame: Day of surgery (Day 1) up to Day 90 after surgery
measure: Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery
timeFrame: Day of surgery (Day 1) up to Day 180 after surgery
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Barrow Brain and Spine
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Greenbaum Surgical Specialty Hospital
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth Scottsdale Osborn Medical Center
state: Arizona
city: Beverly Hills
country: United States
facility: Clinical Office - Jason Cuellar M.D.
state: California
city: Long Beach
country: United States
facility: Memorial Orthopaedic Surgical Group
state: California
city: Los Angeles
country: United States
facility: IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital
state: California
city: Los Angeles
country: United States
facility: Keck Hospital of USC
state: California
city: Los Angeles
country: United States
facility: USC Spine Center
state: California
city: Los Angeles
country: United States
facility: USC/Department of Neurological Surgery
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center - Investigational Drug
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Clinical Office
state: California
city: Los Angeles
country: United States
facility: The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan Med Center - University of California, Los Angeles (UCLA)
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA CTRC Outpatient Unit
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Pediatric Clinic
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Santa Monica
country: United States
facility: UCLA Spine Center
state: California
city: Santa Monica
country: United States
facility: Santa Monica UCLA Medical Center & Orthopaedic Hospital
state: California
city: Santa Monica
country: United States
facility: UCLA Santa Monica Infectious Disease
state: California
city: Torrance
country: United States
facility: LA BioMed at Harbor-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: LA BioMed, Harbor-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: LA BioMed at Harbor-UCLA Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Clinical & Translational Research Center Clinic
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver, School of Medicine
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Boulder
country: United States
facility: Boulder Community Health - Foothills Hospital
state: Colorado
city: Boulder
country: United States
facility: Boulder Community Health
state: Colorado
city: Boulder
country: United States
facility: Justin Parker Neurological Institute
state: Colorado
city: Lone Tree
country: United States
facility: University of Colorado Hospital, Lone Tree Health Center
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital - Investigational Drug Services
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital - St. Raphael campus
state: Connecticut
city: New Haven
country: United States
facility: Ycci-Csru
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital Spine Center
state: Connecticut
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Melbourne
country: United States
facility: The B.A.C.K. Center
state: Florida
city: Melbourne
country: United States
facility: Melbourne Regional Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics and Research Pharmacy
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando
state: Florida
city: Orlando
country: United States
facility: Neuroscience ACS Research
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy
state: Florida
city: Sarasota
country: United States
facility: Gulfcoast Research Institute, LLC
state: Florida
city: Atlanta
country: United States
facility: Emory University Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory Orthopaedics & Spine Center
state: Georgia
city: Tucker
country: United States
facility: Emory Orthopaedics & Spine Hospital
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Idaho Falls
country: United States
facility: Bingham Memorial Specialty Clinic
state: Idaho
city: Idaho Falls
country: United States
facility: Brent H. Greenwald, M.D. Neurological Surgery
state: Idaho
city: Idaho Falls
country: United States
facility: Eastern Idaho Regional Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Mountain View Hospital
state: Idaho
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC
state: Idaho
city: Pocatello
country: United States
facility: Physicians & Surgeons Clinic
state: Idaho
city: Pocatello
country: United States
facility: Bingham Memorial Family Medicine & Specialty Clinic
state: Idaho
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital and Health Sciences System
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC)
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center Pharmacy
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center Professional Office Building Infusion Pharmacy
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: Norton Healthcare Pharmacy
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Leatherman Spine Center
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Annapolis
country: United States
facility: AAMC Research Pharmacy
state: Maryland
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Institute (AAHSRI)
state: Maryland
city: Annapolis
country: United States
facility: Anne Arundel Medical Center Infusion Center
state: Maryland
city: Annapolis
country: United States
facility: Anne Arundel Medical Center Laboratory
state: Maryland
city: Annapolis
country: United States
facility: Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Systems, Department of Neurosurgery
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland Medical Systems, Investigational Drug Services
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland, Medical Systems, Oriole Park
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center
state: Maryland
city: Baltimore
country: United States
facility: John Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital Investigational Drug Service
state: Maryland
city: Bowie
country: United States
facility: Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
state: Maryland
city: Odenton
country: United States
facility: Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
state: Maryland
city: Pasadena
country: United States
facility: Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital, Clinical Research Pharmacy
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital Investigational Drug Services (IDS)
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center- Clinical Research Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical Center Memorial Campus
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Investigational Pharmacy
state: Michigan
city: Ann Arbor
country: United States
facility: University Of Michigan Hospitals
state: Michigan
city: Detroit
country: United States
facility: Detroit Receiving Hospital, Heart Hospital, Harper Hospital at
state: Michigan
city: Grand Rapids
country: United States
facility: Butterworth Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Blodgett Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Orthopaedic Associates of Michigan - Research
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Spine and Scoliosis Specialists
state: Michigan
city: Rochester Hills
country: United States
facility: Michigan Orthopaedic & Spine Surgeons
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Orthopaedic Center
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Southfield
country: United States
facility: Michigan Orthopaedic Institute
state: Michigan
city: Troy
country: United States
facility: Beaumont Health-Troy
state: Michigan
city: West Bloomfield
country: United States
facility: Michigan Orthopaedic Institute
state: Michigan
city: Minneapolis
country: United States
facility: Twin Cities Spine Surgeons dba Twin Cities Spine Center
state: Minnesota
city: Minneapolis
country: United States
facility: Allina Health - Abbott Northwestern Hospital /
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Hospital, Methodist Campus
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester, Methodist Hospital Campus
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Hospital, Methodist Campus
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Center for Outpatient Health
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Barnes Jewish Pharmacy
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Pharmacy
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Marlton
country: United States
facility: The Rothman Institute Marlton, NJ Office
state: New Jersey
city: Montclair
country: United States
facility: HackensackUMC Mountainside Hospital
state: New Jersey
city: Neptune
country: United States
facility: Meridian Hospitals Corp c/o Jersey Shore University Medical Center
state: New Jersey
city: Newark
country: United States
facility: Ambulatory Care Center
state: New Jersey
city: Newark
country: United States
facility: Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School
state: New Jersey
city: Newark
country: United States
facility: Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School
state: New Jersey
city: Newark
country: United States
facility: University Hospital - Pharmacy
state: New Jersey
city: Newark
country: United States
facility: University Hospital
state: New Jersey
city: Sewell
country: United States
facility: The Rothman Institute Washington Township, NJ Office
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck
state: New York
city: Huntington Station
country: United States
facility: NYU Langone Huntington Medical Group
state: New York
city: Johnson City
country: United States
facility: UHS Neurosurgery
state: New York
city: Johnson City
country: United States
facility: UHS Wilson Medical Center
state: New York
city: Lynbrook
country: United States
facility: Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
city: New York
country: United States
facility: NYU Langone Health Orthopedic Hospital
state: New York
city: New York
country: United States
facility: Kimmel Pavillion
state: New York
city: New York
country: United States
facility: NYU Langone Health Orthopedic Center
state: New York
city: New York
country: United States
facility: NYU Langone Health Tisch Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Madison Ave. Orthopedics
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: lcahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: The Clinical Research Unit at Mount Sinai
state: New York
city: New York
country: United States
facility: NYU Langone Seaport Orthopaedics
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Associates, P.A.
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Hip & Knee Center
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Pineville
state: North Carolina
city: Charlotte
country: United States
facility: OrthoCarolina Ballantyne
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital, IDS Pharmacy
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Matthews
country: United States
facility: OrthoCarolina Matthews
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation - Investigation Pharmacy
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Center for Spine Health
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital Pharmacy
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis, Inc.
state: Ohio
city: Columbus
country: United States
facility: Orthopedic One
state: Ohio
city: Dublin
country: United States
facility: Dublin Methodist Hospital
state: Ohio
city: Portland
country: United States
facility: OHSU Research Pharmacy
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Abington
country: United States
facility: Abington Jefferson Health-Pharmacy Department
state: Pennsylvania
city: Abington
country: United States
facility: Abington Jefferson Health
state: Pennsylvania
city: Chalfont
country: United States
facility: Rothman Institute-Chalfont Office
state: Pennsylvania
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center Pharmacy
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Drug Service Pharmacy
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Hospital For Neuroscience
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Rothman Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital - Pre-Admission Testing Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital, Cardiovascular Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Upmc (Puh/Muh)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
city: Willow Grove
country: United States
facility: Rothman Institute-Willow Grove Office
state: Pennsylvania
city: Austin
country: United States
facility: Dell Seton Medical Center at The University of Texas
state: Texas
city: Austin
country: United States
facility: Austin Infectious Disease Consultants
state: Texas
city: Austin
country: United States
facility: Employee Wellness Center
state: Texas
city: Austin
country: United States
facility: Seton Medical Center Austin
state: Texas
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Austin
country: United States
facility: St. David's Neuroscience and Spine Institute
state: Texas
city: Austin
country: United States
facility: Seton Spine and Scoliosis Center
state: Texas
city: Austin
country: United States
facility: St. David's North Austin Medical Center
state: Texas
city: Austin
country: United States
facility: Wellness Brain and Spine
state: Texas
city: Fredericksburg
country: United States
facility: Neurosurgical Specialist of Texas
state: Texas
city: Houston
country: United States
facility: Hermann Drive Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Mermorial Hermann - Memorial City Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - McNair Campus
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White Medical Center
state: Texas
city: Round Rock
country: United States
facility: Seton Brain and Spine Institute Williamson
state: Texas
city: Round Rock
country: United States
facility: Seton Medical Center Williamson
state: Texas
city: Round Rock
country: United States
facility: St. David's Round Rock Medical Center
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute)
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital and Clinic
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Annandale
country: United States
facility: Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
state: Virginia
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Fairfax
country: United States
facility: Inova Medical Group
state: Virginia
city: Fairfax
country: United States
facility: Inova Fair Oaks Hospital
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Falls Church
country: United States
facility: Inova Neurosciences Research
state: Virginia
city: McLean
country: United States
facility: OrthoVirginia
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Medical Group DBA Sentara Neurosurgery Specialists
state: Virginia
city: Richamond
country: United States
facility: VCU Medical Center Investigational Drug Service
state: Virginia
city: Richmond
country: United States
facility: VCU Heatlh Neuroscience Orthopedic and Wellness Center
state: Virginia
city: Richmond
country: United States
facility: VCU Health Ambulatory Care Center
state: Virginia
city: Richmond
country: United States
facility: VCU Health
state: Virginia
city: Roanoke
country: United States
facility: Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S)
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic - Department of Pharmacy
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Institute for Orthopaedics and Neurosciences
state: Virginia
city: Roanoke
country: United States
facility: Carilion Roanoke Memorial Hospital
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Riverside 3
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Morgantown
country: United States
facility: WVU Medicine Spine Center
state: West Virginia
city: Morgantown
country: United States
facility: WVU Medicine JW Ruby Memorial Hospital
state: West Virginia
city: Morgantown
country: United States
facility: WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy
state: West Virginia
city: Morgantown
country: United States
facility: WVU Medicine Physician Office Center Orthopaedic Surgery
state: West Virginia
city: Morgantown
country: United States
facility: WVU Medicine Physician Office Center
state: West Virginia
city: Innsbruck
country: Austria
facility: Tirol Kliniken GmbH
city: Innsbruck
country: Austria
facility: Tirol Kliniken
city: Varna
country: Bulgaria
facility: MHAT "Sveta Marina" EAD
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre, University of Calgary
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: St, Michael's Hospital - St. Michael's Pharmacy
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Neurological Hospital Research Pharmacy
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital Research Institute of the MUHC- MGH Pharmacy Research
state: Quebec
city: Bordeaux
country: France
facility: CHU Pellegrin Tripode
city: Bordeaux
country: France
facility: CHU Pellegrin, Pharmacie
city: Dijon
country: France
facility: CHU de Dijon
city: Dijon
country: France
facility: CHU de Dijon
city: Dijon
country: France
facility: CHU Hopital d'Enfants
city: Marseille Cedex 20
country: France
facility: AP-HM Hopital Nord
city: Marseille Cedex 5
country: France
facility: AP-HM La Timone - Hopital adultes
city: Nantes Cedex 1
country: France
facility: CHU de Nantes - Hotel Dieu
city: Nimes Cedex 9
country: France
facility: CHU de Nimes
city: Nîmes Cedex 9
country: France
facility: CHU de Nimes - Caremeau
city: Nîmes Cedex 9
country: France
facility: CHU de Nimes
city: Paris
country: France
facility: CIC Cochin/Pasteur (CIC 1417)
city: Paris
country: France
facility: Service de Chirurgie Orthopedique et Traumatologie
city: Paris
country: France
facility: Service de Pharmacie
city: Rennes, Cedex 9
country: France
facility: CHU de Rennes - Hopital Pontchaillou
city: Rennes, Cedex 9
country: France
facility: Unite d'investigation clinique
city: Rennes
country: France
facility: CHU de Rennes
city: Saint Priest en Jarez
country: France
facility: Hopital Nord-CHU Saint Etienne
city: Strasbourg
country: France
facility: Hopital Civil
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Berlin
country: Germany
facility: Charite- University Medicine Berlin
city: Berlin
country: Germany
facility: Charite- University Medicine Berlin
city: Koeln
country: Germany
facility: Uniklinik Koeln
city: Munchen
country: Germany
facility: Klinikum rechts der Isar, Technische Universitat Munchen
city: Munchen
country: Germany
facility: Klinikum rechts der Isar
city: Munster
country: Germany
facility: St. Franziskus Hospital Munster
city: Budapest
country: Hungary
facility: Orszagos Gerincgyogyaszati Kozpont
city: Hakodate
country: Japan
facility: Hakodate Central General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Medical Center
state: Hokkaido
city: Kawasaki
country: Japan
facility: Japan Organization of Occupational Health and Safety, Kanto Rosai Hospital
state: Kanagawa
city: Sasebo
country: Japan
facility: Nagasaki Rosai Hospital
state: Nagasaki
city: Kawaguchi
country: Japan
facility: Saiseikai Kawaguchi General Hospital
state: Saitama
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
state: Shizuoka
city: Musashimurayama
country: Japan
facility: National Hospital Organization Murayama Medical Center
state: Tokyo
city: Musashino
country: Japan
facility: Musashino Red Cross Hospital
state: Tokyo
city: Shimonoseki-shi
country: Japan
facility: Shimonoseki City Hospital
state: Yamaguchi
city: Osaka
country: Japan
facility: Japan Community Health care Organization Osaka Hospital
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario Santiago de Compostela
state: A Coruna
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Ramon Y Cajal
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario Politecnico La Fe
city: Valladolid
country: Spain
facility: Pharmacy Service of Hospital Clinico de Valladolid
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Upplands Vasby
country: Sweden
facility: GHP Stockholm Spine Center
city: Middlesbrough
country: United Kingdom
facility: Pharmacy Store, Main Pharmacy
state: Cleveland
city: Middlesbrough
country: United Kingdom
facility: Pharmacy Store
state: Cleveland
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
state: Cleveland
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital
state: Cleveland
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
city: Nottingham
country: United Kingdom
facility: Centre for Spinal Studies and Surgery
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: