Staphylococcal Vaccine Clinical Trial
— STRIVEOfficial 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
| Verified date | November 2020 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 3450 |
| Est. completion date | June 27, 2019 |
| Est. primary completion date | June 26, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Austria | Tirol Kliniken | Innsbruck | |
| Austria | Tirol Kliniken GmbH | Innsbruck | |
| Bulgaria | MHAT "Sveta Marina" EAD | Varna | |
| Canada | Foothills Medical Centre | Calgary | Alberta |
| Canada | Foothills Medical Centre, University of Calgary | Calgary | Alberta |
| Canada | Montreal General Hospital Research Institute of the MUHC- MGH Pharmacy Research | Montreal | Quebec |
| Canada | Montreal Neurological Hospital Research Pharmacy | Montreal | Quebec |
| Canada | Montreal Neurological Institute and Hospital | Montreal | Quebec |
| Canada | The Ottawa Hospital, Civic Campus | Ottawa | Ontario |
| Canada | St, Michael's Hospital - St. Michael's Pharmacy | Toronto | Ontario |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | St. Michael's Hospital | Toronto | Ontario |
| Canada | Toronto Western Hospital | Toronto | Ontario |
| France | CHU Pellegrin Tripode | Bordeaux | |
| France | CHU Pellegrin, Pharmacie | Bordeaux | |
| France | CHU de Dijon | Dijon | |
| France | CHU de Dijon | Dijon | |
| France | CHU Hopital d'Enfants | Dijon | |
| France | AP-HM Hopital Nord | Marseille Cedex 20 | |
| France | AP-HM La Timone - Hopital adultes | Marseille Cedex 5 | |
| France | CHU de Nantes - Hotel Dieu | Nantes Cedex 1 | |
| France | CHU de Nimes | Nimes Cedex 9 | |
| France | CHU de Nimes | Nîmes Cedex 9 | |
| France | CHU de Nimes - Caremeau | Nîmes Cedex 9 | |
| France | CIC Cochin/Pasteur (CIC 1417) | Paris | |
| France | Service de Chirurgie Orthopedique et Traumatologie | Paris | |
| France | Service de Pharmacie | Paris | |
| France | CHU de Rennes | Rennes | |
| France | CHU de Rennes - Hopital Pontchaillou | Rennes, Cedex 9 | |
| France | Unite d'investigation clinique | Rennes, Cedex 9 | |
| France | Hopital Nord-CHU Saint Etienne | Saint Priest en Jarez | |
| France | Hopital Civil | Strasbourg | |
| France | Hopitaux Universitaires de Strasbourg | Strasbourg | |
| Germany | Charite- University Medicine Berlin | Berlin | |
| Germany | Charite- University Medicine Berlin | Berlin | |
| Germany | Uniklinik Koeln | Koeln | |
| Germany | Klinikum rechts der Isar | Munchen | |
| Germany | Klinikum rechts der Isar, Technische Universitat Munchen | Munchen | |
| Germany | St. Franziskus Hospital Munster | Munster | |
| Hungary | Orszagos Gerincgyogyaszati Kozpont | Budapest | |
| Japan | Hakodate Central General Hospital | Hakodate | Hokkaido |
| Japan | Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka |
| Japan | Saiseikai Kawaguchi General Hospital | Kawaguchi | Saitama |
| Japan | Japan Organization of Occupational Health and Safety, Kanto Rosai Hospital | Kawasaki | Kanagawa |
| Japan | National Hospital Organization Murayama Medical Center | Musashimurayama | Tokyo |
| Japan | Musashino Red Cross Hospital | Musashino | Tokyo |
| Japan | Japan Community Health care Organization Osaka Hospital | Osaka | |
| Japan | National Hospital Organization Hokkaido Medical Center | Sapporo | Hokkaido |
| Japan | Nagasaki Rosai Hospital | Sasebo | Nagasaki |
| Japan | Shimonoseki City Hospital | Shimonoseki-shi | Yamaguchi |
| Spain | Hospital Universitario Fundacion Alcorcon | Alcorcon | Madrid |
| Spain | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
| Spain | Hospital Ramon Y Cajal | Madrid | |
| Spain | Hospital Clínico Universitario Santiago de Compostela | Santiago de Compostela | A Coruna |
| Spain | Hospital Universitario Virgen del Rocio | Sevilla | |
| Spain | Hospital Universitario Politecnico La Fe | Valencia | |
| Spain | Hospital Clinico Universitario de Valladolid | Valladolid | |
| Spain | Pharmacy Service of Hospital Clinico de Valladolid | Valladolid | |
| Sweden | GHP Stockholm Spine Center | Upplands Vasby | |
| United Kingdom | Pharmacy Store | Middlesbrough | Cleveland |
| United Kingdom | Pharmacy Store, Main Pharmacy | Middlesbrough | Cleveland |
| United Kingdom | South Tees Hospitals NHS Foundation Trust | Middlesbrough | Cleveland |
| United Kingdom | The James Cook University Hospital | Middlesbrough | Cleveland |
| United Kingdom | Centre for Spinal Studies and Surgery | Nottingham | |
| United Kingdom | Salford Royal NHS Foundation Trust | Salford | Greater Manchester |
| United Kingdom | Southampton General Hospital | Southampton | |
| United States | Abington Jefferson Health | Abington | Pennsylvania |
| United States | Abington Jefferson Health-Pharmacy Department | Abington | Pennsylvania |
| United States | University Of Michigan Hospitals | Ann Arbor | Michigan |
| United States | University of Michigan Investigational Pharmacy | Ann Arbor | Michigan |
| United States | Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID) | Annandale | Virginia |
| United States | AAMC Research Pharmacy | Annapolis | Maryland |
| United States | Anne Arundel Health System Research Institute (AAHSRI) | Annapolis | Maryland |
| United States | Anne Arundel Medical Center Infusion Center | Annapolis | Maryland |
| United States | Anne Arundel Medical Center Laboratory | Annapolis | Maryland |
| United States | Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Annapolis | Maryland |
| United States | Emory Orthopaedics & Spine Center | Atlanta | Georgia |
| United States | Emory University Clinic | Atlanta | Georgia |
| United States | University of Colorado Clinical & Translational Research Center Clinic | Aurora | Colorado |
| United States | University of Colorado Denver, School of Medicine | Aurora | Colorado |
| United States | University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage | Aurora | Colorado |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Austin Infectious Disease Consultants | Austin | Texas |
| United States | Dell Seton Medical Center at The University of Texas | Austin | Texas |
| United States | Employee Wellness Center | Austin | Texas |
| United States | Seton Medical Center Austin | Austin | Texas |
| United States | Seton Spine and Scoliosis Center | Austin | Texas |
| United States | St. David's Medical Center | Austin | Texas |
| United States | St. David's Neuroscience and Spine Institute | Austin | Texas |
| United States | St. David's North Austin Medical Center | Austin | Texas |
| United States | Wellness Brain and Spine | Austin | Texas |
| United States | Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center | Baltimore | Maryland |
| United States | John Hopkins Bayview Medical Center | Baltimore | Maryland |
| United States | John Hopkins Hospital | Baltimore | Maryland |
| United States | Johns Hopkins Bayview Medical Center | Baltimore | Maryland |
| United States | The Johns Hopkins Hospital Investigational Drug Service | Baltimore | Maryland |
| United States | University of Maryland Medical Systems, Department of Neurosurgery | Baltimore | Maryland |
| United States | University of Maryland Medical Systems, Investigational Drug Services | Baltimore | Maryland |
| United States | University of Maryland, Medical Systems, Oriole Park | Baltimore | Maryland |
| United States | Clinical Office - Jason Cuellar M.D. | Beverly Hills | California |
| United States | The University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Bingham Memorial Hospital | Blackfoot | Idaho |
| United States | Brigham and Women's Hospital | Boston | Massachusetts |
| United States | Brigham and Women's Hospital Investigational Drug Services (IDS) | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Massachusetts General Hospital, Clinical Research Pharmacy | Boston | Massachusetts |
| United States | Boulder Community Health | Boulder | Colorado |
| United States | Boulder Community Health - Foothills Hospital | Boulder | Colorado |
| United States | Justin Parker Neurological Institute | Boulder | Colorado |
| United States | Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Bowie | Maryland |
| United States | Rothman Institute-Chalfont Office | Chalfont | Pennsylvania |
| United States | Carolina Neurosurgery and Spine Associates, P.A. | Charlotte | North Carolina |
| United States | Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital | Charlotte | North Carolina |
| United States | OrthoCarolina | Charlotte | North Carolina |
| United States | OrthoCarolina Ballantyne | Charlotte | North Carolina |
| United States | OrthoCarolina Hip & Knee Center | Charlotte | North Carolina |
| United States | OrthoCarolina Pineville | Charlotte | North Carolina |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC) | Chicago | Illinois |
| United States | Rush University Medical Center Pharmacy | Chicago | Illinois |
| United States | Rush University Medical Center Professional Office Building Infusion Pharmacy | Chicago | Illinois |
| United States | University of Illinois Hospital and Health Sciences System | Chicago | Illinois |
| United States | University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services | Chicago | Illinois |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | The Lindner Center for Research and Education at The Christ Hospital | Cincinnati | Ohio |
| United States | Cleveland Clinic Foundation - Investigation Pharmacy | Cleveland | Ohio |
| United States | Cleveland Clinic Foundation Center for Spine Health | Cleveland | Ohio |
| United States | Orthopedic One | Columbus | Ohio |
| United States | Remington-Davis, Inc. | Columbus | Ohio |
| United States | Riverside Methodist Hospital Pharmacy | Columbus | Ohio |
| United States | Detroit Receiving Hospital, Heart Hospital, Harper Hospital at | Detroit | Michigan |
| United States | Dublin Methodist Hospital | Dublin | Ohio |
| United States | Duke University Hospital | Durham | North Carolina |
| United States | Duke University Hospital, IDS Pharmacy | Durham | North Carolina |
| United States | Inova Fair Oaks Hospital | Fairfax | Virginia |
| United States | Inova Medical Group | Fairfax | Virginia |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Inova Neurosciences Research | Falls Church | Virginia |
| United States | Neurosurgical Specialist of Texas | Fredericksburg | Texas |
| United States | Blodgett Hospital | Grand Rapids | Michigan |
| United States | Butterworth Hospital | Grand Rapids | Michigan |
| United States | Orthopaedic Associates of Michigan - Research | Grand Rapids | Michigan |
| United States | Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck | Great Neck | New York |
| United States | Milton S. Hershey Medical Center Pharmacy | Hershey | Pennsylvania |
| United States | Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Baylor College of Medicine - McNair Campus | Houston | Texas |
| United States | CHI St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas |
| United States | Hermann Drive Surgical Hospital | Houston | Texas |
| United States | Mermorial Hermann - Memorial City Medical Center | Houston | Texas |
| United States | NYU Langone Huntington Medical Group | Huntington Station | New York |
| United States | Bingham Memorial Specialty Clinic | Idaho Falls | Idaho |
| United States | Brent H. Greenwald, M.D. Neurological Surgery | Idaho Falls | Idaho |
| United States | Eastern Idaho Regional Medical Center | Idaho Falls | Idaho |
| United States | Mountain View Hospital | Idaho Falls | Idaho |
| United States | Snake River Research, PLLC | Idaho Falls | Idaho |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | UHS Neurosurgery | Johnson City | New York |
| United States | UHS Wilson Medical Center | Johnson City | New York |
| United States | Bronson Methodist Hospital | Kalamazoo | Michigan |
| United States | Bronson Spine and Scoliosis Specialists | Kalamazoo | Michigan |
| United States | University of Kansas Hospital | Kansas City | Kansas |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
| United States | University of Colorado Hospital, Lone Tree Health Center | Lone Tree | Colorado |
| United States | Memorial Orthopaedic Surgical Group | Long Beach | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Cedars-Sinai Medical Center - Investigational Drug | Los Angeles | California |
| United States | Clinical Office | Los Angeles | California |
| United States | IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
| United States | Keck Hospital of USC | Los Angeles | California |
| United States | Ronald Reagan Med Center - University of California, Los Angeles (UCLA) | Los Angeles | California |
| United States | Ronald Reagan UCLA Medical Center | Los Angeles | California |
| United States | The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center | Los Angeles | California |
| United States | UCLA CTRC Outpatient Unit | Los Angeles | California |
| United States | USC Spine Center | Los Angeles | California |
| United States | USC/Department of Neurological Surgery | Los Angeles | California |
| United States | Norton Healthcare Pharmacy | Louisville | Kentucky |
| United States | Norton Hospital | Louisville | Kentucky |
| United States | Norton Leatherman Spine Center | Louisville | Kentucky |
| United States | Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook | Lynbrook | New York |
| United States | North Shore University Hospital | Manhasset | New York |
| United States | The Feinstein Institute for Medical Research | Manhasset | New York |
| United States | The Rothman Institute Marlton, NJ Office | Marlton | New Jersey |
| United States | OrthoCarolina Matthews | Matthews | North Carolina |
| United States | OrthoVirginia | McLean | Virginia |
| United States | Holmes Regional Medical Center | Melbourne | Florida |
| United States | Melbourne Regional Medical Center | Melbourne | Florida |
| United States | The B.A.C.K. Center | Melbourne | Florida |
| United States | University of Miami Hospital | Miami | Florida |
| United States | University of Miami Hospital and Clinics and Research Pharmacy | Miami | Florida |
| United States | Allina Health - Abbott Northwestern Hospital / | Minneapolis | Minnesota |
| United States | Twin Cities Spine Surgeons dba Twin Cities Spine Center | Minneapolis | Minnesota |
| United States | HackensackUMC Mountainside Hospital | Montclair | New Jersey |
| United States | WVU Medicine JW Ruby Memorial Hospital | Morgantown | West Virginia |
| United States | WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy | Morgantown | West Virginia |
| United States | WVU Medicine Physician Office Center | Morgantown | West Virginia |
| United States | WVU Medicine Physician Office Center Orthopaedic Surgery | Morgantown | West Virginia |
| United States | WVU Medicine Spine Center | Morgantown | West Virginia |
| United States | Meridian Hospitals Corp c/o Jersey Shore University Medical Center | Neptune | New Jersey |
| United States | Yale New Haven Hospital | New Haven | Connecticut |
| United States | Yale New Haven Hospital - Investigational Drug Services | New Haven | Connecticut |
| United States | Yale New Haven Hospital - St. Raphael campus | New Haven | Connecticut |
| United States | Yale-New Haven Hospital Spine Center | New Haven | Connecticut |
| United States | Ycci-Csru | New Haven | Connecticut |
| United States | Ochsner Baptist Medical Center | New Orleans | Louisiana |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Hospital for Special Surgery | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | Kimmel Pavillion | New York | New York |
| United States | lcahn School of Medicine at Mount Sinai | New York | New York |
| United States | NYU Langone Health Orthopedic Center | New York | New York |
| United States | NYU Langone Health Orthopedic Hospital | New York | New York |
| United States | NYU Langone Health Tisch Hospital | New York | New York |
| United States | NYU Langone Madison Ave. Orthopedics | New York | New York |
| United States | NYU Langone Seaport Orthopaedics | New York | New York |
| United States | The Clinical Research Unit at Mount Sinai | New York | New York |
| United States | Ambulatory Care Center | Newark | New Jersey |
| United States | Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School | Newark | New Jersey |
| United States | Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School | Newark | New Jersey |
| United States | University Hospital | Newark | New Jersey |
| United States | University Hospital - Pharmacy | Newark | New Jersey |
| United States | Sentara Medical Group DBA Sentara Neurosurgery Specialists | Norfolk | Virginia |
| United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
| United States | Kaiser Permanente Pediatric Clinic | Oakland | California |
| United States | Kaiser Permanente Vaccine Study Center | Oakland | California |
| United States | Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Odenton | Maryland |
| United States | University of California Irvine Medical Center | Orange | California |
| United States | Florida Hospital Orlando | Orlando | Florida |
| United States | Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy | Orlando | Florida |
| United States | Neuroscience ACS Research | Orlando | Florida |
| United States | Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists | Pasadena | Maryland |
| United States | Investigational Drug Service Pharmacy | Philadelphia | Pennsylvania |
| United States | Jefferson Hospital For Neuroscience | Philadelphia | Pennsylvania |
| United States | The Rothman Institute | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital - Pre-Admission Testing Center | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital, Cardiovascular Associates | Philadelphia | Pennsylvania |
| United States | Barrow Brain and Spine | Phoenix | Arizona |
| United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | Upmc (Puh/Muh) | Pittsburgh | Pennsylvania |
| United States | UPMC Presbyterian | Pittsburgh | Pennsylvania |
| United States | Baylor Scott & White Medical Center | Plano | Texas |
| United States | Bingham Memorial Family Medicine & Specialty Clinic | Pocatello | Idaho |
| United States | Physicians & Surgeons Clinic | Pocatello | Idaho |
| United States | OHSU Research Pharmacy | Portland | Oregon |
| United States | Oregon Health and Sciences University | Portland | Oregon |
| United States | VCU Medical Center Investigational Drug Service | Richamond | Virginia |
| United States | VCU Health | Richmond | Virginia |
| United States | VCU Health Ambulatory Care Center | Richmond | Virginia |
| United States | VCU Heatlh Neuroscience Orthopedic and Wellness Center | Richmond | Virginia |
| United States | Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S) | Roanoke | Virginia |
| United States | Carilion Clinic - Department of Pharmacy | Roanoke | Virginia |
| United States | Carilion Clinic Institute for Orthopaedics and Neurosciences | Roanoke | Virginia |
| United States | Carilion Clinic Riverside 3 | Roanoke | Virginia |
| United States | Carilion Roanoke Memorial Hospital | Roanoke | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | Mayo Clinic Hospital, Methodist Campus | Rochester | Minnesota |
| United States | Mayo Clinic Hospital, Methodist Campus | Rochester | Minnesota |
| United States | Mayo Clinic Rochester, Methodist Hospital Campus | Rochester | Minnesota |
| United States | Michigan Orthopaedic & Spine Surgeons | Rochester Hills | Michigan |
| United States | Seton Brain and Spine Institute Williamson | Round Rock | Texas |
| United States | Seton Medical Center Williamson | Round Rock | Texas |
| United States | St. David's Round Rock Medical Center | Round Rock | Texas |
| United States | Beaumont Orthopaedic Center | Royal Oak | Michigan |
| United States | William Beaumont Hospital | Royal Oak | Michigan |
| United States | Barnes Jewish Center for Advanced Medicine | Saint Louis | Missouri |
| United States | Barnes Jewish Hospital | Saint Louis | Missouri |
| United States | Barnes Jewish Pharmacy | Saint Louis | Missouri |
| United States | Barnes-Jewish Pharmacy | Saint Louis | Missouri |
| United States | Center for Outpatient Health | Saint Louis | Missouri |
| United States | Washington University | Saint Louis | Missouri |
| United States | University of California, San Francisco | San Francisco | California |
| United States | Santa Monica UCLA Medical Center & Orthopaedic Hospital | Santa Monica | California |
| United States | UCLA Santa Monica Infectious Disease | Santa Monica | California |
| United States | UCLA Spine Center | Santa Monica | California |
| United States | Gulfcoast Research Institute, LLC | Sarasota | Florida |
| United States | Greenbaum Surgical Specialty Hospital | Scottsdale | Arizona |
| United States | HonorHealth Scottsdale Osborn Medical Center | Scottsdale | Arizona |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | The Rothman Institute Washington Township, NJ Office | Sewell | New Jersey |
| United States | Spine Institute of Louisiana | Shreveport | Louisiana |
| United States | Michigan Orthopaedic Institute | Southfield | Michigan |
| United States | Scott & White Memorial Hospital | Temple | Texas |
| United States | Scott & White Memorial Hospital and Clinic | Temple | Texas |
| United States | Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute) | Temple | Texas |
| United States | Harbor-UCLA Medical Center | Torrance | California |
| United States | LA BioMed at Harbor-UCLA Medical Center | Torrance | California |
| United States | LA BioMed at Harbor-UCLA Medical Center | Torrance | California |
| United States | LA BioMed, Harbor-UCLA Medical Center | Torrance | California |
| United States | Beaumont Health-Troy | Troy | Michigan |
| United States | Emory Orthopaedics & Spine Hospital | Tucker | Georgia |
| United States | Michigan Orthopaedic Institute | West Bloomfield | Michigan |
| United States | Rothman Institute-Willow Grove Office | Willow Grove | Pennsylvania |
| United States | UMass Memorial Medical Center | Worcester | Massachusetts |
| United States | UMass Memorial Medical Center- Clinical Research Center | Worcester | Massachusetts |
| United States | University of Massachusetts Medical Center Memorial Campus | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Austria, Bulgaria, Canada, France, Germany, Hungary, Japan, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (example [e.g.] fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 90 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by event adjudication committee (EAC) have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space). | Day of surgery (Day 1) up to Day 90 | |
| Primary | Percentage of Participants With Local Reactions Within 10 Days After Vaccination | Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were categorized as mild (2.5 to 5.0 centimeters [cm]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to [>=] 10.5 cm). Pain at the injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling, pain at the injection site represents any grade of these local reactions among mild, moderate or severe. | Within 10 days after Vaccination | |
| Primary | Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination | Systemic reactions included fever, fatigue, headache, diarrhea, vomiting, muscle pain and joint pain, were recorded using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Participants may be represented in more than 1 row. Here "any" for fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain represents any grade of these systemic reactions among mild, moderate or severe. | Within 10 days after Vaccination | |
| Primary | Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1) | An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs. | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | |
| Primary | Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs. | From vaccination until Day 42 after surgery (52-102 days after vaccination) | |
| Primary | Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs. | Day of surgery (Day 1) up to Day 42 after surgery | |
| Primary | Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180 | A newly diagnosed chronic medical disorder was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Day 42 up to Day 180 (up to 138 days) | |
| Primary | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. | From vaccination up to Day 180 after surgery (190-240 days after vaccination) | |
| Primary | Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. | From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination) | |
| Primary | Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180 | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly. | Day of surgery (Day 1) up to Day 180 after surgery | |
| Secondary | 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 | BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 180 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by EAC have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space). | Day of surgery (Day 1) up to Day 180 after surgery | |
| Secondary | Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery | SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body, excluding skin incision, fascia, or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 90 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported. | Day of surgery (Day 1) up to Day 90 after surgery | |
| Secondary | Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery | SSI: infection at a surgical incision. Types of SSI in this outcome measure: Superficial SSI: Infection involved only skin and subcutaneous tissue of the incision, Deep incisional SSI: infection involved deep soft tissues of incision (e.g. fascial and muscle layers), Organ/space SSI: infection involved any part of body, excluding skin incision, fascia, or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative SSI (including superficial, deep incisional and/or organ/space SSI) caused by S. aureus, occurred within 180 days after elective open posterior spinal fusion surgery with multilevel instrumentation as confirmed by EAC have been reported. | Day of surgery (Day 1) up to Day 180 after surgery |