Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation (STRIVE)

December 11, 2020 updated by: Pfizer

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

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 Overview

Study Type

Interventional

Enrollment (Actual)

3450

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Innsbruck, Austria, 6020
        • Tirol Kliniken GmbH
      • Innsbruck, Austria, 6020
        • Tirol Kliniken
      • Varna, Bulgaria, 9010
        • MHAT "Sveta Marina" EAD
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Centre
      • Calgary, Alberta, Canada, T2N 4Z6
        • Foothills Medical Centre, University of Calgary
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital, Civic Campus
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M5B 1M4
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St, Michael's Hospital - St. Michael's Pharmacy
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute and Hospital
      • Montreal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Hospital Research Pharmacy
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital Research Institute of the MUHC- MGH Pharmacy Research
      • Bordeaux, France, 33076
        • CHU Pellegrin Tripode
      • Bordeaux, France, 33076
        • CHU Pellegrin, Pharmacie
      • Dijon, France, 21079
        • CHU de DIJON
      • Dijon, France, 21000
        • CHU de DIJON
      • Dijon, France, 21079
        • CHU Hôpital d'Enfants
      • Marseille Cedex 20, France, 13915
        • AP-HM Hôpital Nord
      • Marseille Cedex 5, France, 13385
        • AP-HM La Timone - Hopital adultes
      • Nantes Cedex 1, France, 44093
        • CHU de Nantes - Hotel Dieu
      • Nimes Cedex 9, France, 30029
        • CHU de Nîmes
      • Nîmes Cedex 9, France, 30029
        • CHU de Nimes - Caremeau
      • Nîmes Cedex 9, France, 30029
        • CHU de Nîmes
      • Paris, France, 75014
        • CIC Cochin/Pasteur (CIC 1417)
      • Paris, France, 75014
        • Service de Chirurgie Orthopedique et Traumatologie
      • Paris, France, 75014
        • Service de Pharmacie
      • Rennes, France, 35033
        • CHU de Rennes
      • Rennes, Cedex 9, France, 35033
        • CHU de Rennes - Hôpital Pontchaillou
      • Rennes, Cedex 9, France, 35033
        • Unite d'investigation clinique
      • Saint Priest en Jarez, France, 42270
        • Hôpital Nord-CHU Saint Etienne
      • Strasbourg, France, 67091
        • Hopital Civil
      • Strasbourg, France, 67200
        • Hopitaux Universitaires De Strasbourg
      • Berlin, Germany, 10117
        • Charite- University Medicine Berlin
      • Berlin, Germany, 13353
        • Charite- University Medicine Berlin
      • Koeln, Germany, 50937
        • Uniklinik Koeln
      • Munchen, Germany, 81675
        • Klinikum rechts der Isar
      • Munchen, Germany, 81675
        • Klinikum Rechts der Isar, Technische Universität München
      • Munster, Germany, 48415
        • St. Franziskus Hospital Munster
      • Budapest, Hungary, 1126
        • Orszagos Gerincgyogyaszati Kozpont
      • Osaka, Japan, 553-0003
        • Japan Community Health Care Organization Osaka Hospital
    • Hokkaido
      • Hakodate, Hokkaido, Japan, 040-8585
        • Hakodate Central General Hospital
      • Sapporo, Hokkaido, Japan, 063-0005
        • National Hospital Organization Hokkaido Medical Center
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-8510
        • Japan Organization of Occupational Health and Safety, Kanto Rosai Hospital
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-0134
        • Nagasaki Rosai Hospital
    • Saitama
      • Kawaguchi, Saitama, Japan, 332-8558
        • Saiseikai Kawaguchi General Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8558
        • Seirei Hamamatsu General Hospital
    • Tokyo
      • Musashimurayama, Tokyo, Japan, 208-0011
        • National Hospital Organization Murayama Medical Center
      • Musashino, Tokyo, Japan, 180-8610
        • Musashino Red Cross Hospital
    • Yamaguchi
      • Shimonoseki-shi, Yamaguchi, Japan, 750-8520
        • Shimonoseki City Hospital
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitario Politecnico La Fe
      • Valladolid, Spain, 47005
        • Hospital Clinico Universitario de Valladolid
      • Valladolid, Spain, 47003
        • Pharmacy Service of Hospital Clinico de Valladolid
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Hospital Clinico Universitario Santiago de Compostela
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Upplands Vasby, Sweden, 19489
        • GHP Stockholm Spine Center
      • Nottingham, United Kingdom, NG7 2UH
        • Centre for Spinal Studies and Surgery
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Cleveland
      • Middlesbrough, Cleveland, United Kingdom, TS4 3BW
        • The James Cook University Hospital
      • Middlesbrough, Cleveland, United Kingdom, TS4 3BW
        • South Tees Hospitals NHS Foundation Trust
      • Middlesbrough, Cleveland, United Kingdom, TS4 3BW
        • Pharmacy Store, Main Pharmacy
      • Middlesbrough, Cleveland, United Kingdom, TS4 3BW
        • Pharmacy Store
    • Greater Manchester
      • Salford, Greater Manchester, United Kingdom, M6 8HD
        • Salford Royal NHS Foundation Trust
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • The University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85013
        • Barrow Brain and Spine
      • Scottsdale, Arizona, United States, 85251
        • HonorHealth Scottsdale Osborn Medical Center
      • Scottsdale, Arizona, United States, 85251
        • Greenbaum Surgical Specialty Hospital
    • California
      • Beverly Hills, California, United States, 90210
        • Clinical Office - Jason Cuellar M.D.
      • Long Beach, California, United States, 90806
        • Memorial Orthopaedic Surgical Group
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90033
        • Keck Hospital of USC
      • Los Angeles, California, United States, 90095
        • UCLA CTRC Outpatient Unit
      • Los Angeles, California, United States, 90033
        • IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, United States, 90033
        • USC Spine Center
      • Los Angeles, California, United States, 90033
        • USC/Department of Neurological Surgery
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center - Investigational Drug
      • Los Angeles, California, United States, 90048
        • Clinical Office
      • Los Angeles, California, United States, 90048
        • The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • Ronald Reagan Med Center - University of California, Los Angeles (UCLA)
      • Oakland, California, United States, 94612
        • Kaiser Permanente Vaccine Study Center
      • Oakland, California, United States, 94611
        • Kaiser Permanente Pediatric Clinic
      • Orange, California, United States, 92868
        • University of California Irvine Medical Center
      • San Francisco, California, United States, 94143
        • University of California, San Francisco
      • Santa Monica, California, United States, 90404
        • Santa Monica UCLA Medical Center & Orthopaedic Hospital
      • Santa Monica, California, United States, 90401
        • UCLA Spine Center
      • Santa Monica, California, United States, 90404
        • UCLA Santa Monica Infectious Disease
      • Torrance, California, United States, 90502
        • LA Biomed at Harbor-UCLA Medical Center
      • Torrance, California, United States, 90509
        • Harbor-UCLA Medical Center
      • Torrance, California, United States, 90509
        • LA Biomed at Harbor-UCLA Medical Center
      • Torrance, California, United States, 90502
        • LA BioMed, Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80045
        • University of Colorado Clinical & Translational Research Center Clinic
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver, School of Medicine
      • Aurora, Colorado, United States, 80045
        • University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage
      • Boulder, Colorado, United States, 80303
        • Boulder Community Health - Foothills Hospital
      • Boulder, Colorado, United States, 80303
        • Boulder Community Health
      • Boulder, Colorado, United States, 80303
        • Justin Parker Neurological Institute
      • Lone Tree, Colorado, United States, 80124
        • University of Colorado Hospital, Lone Tree Health Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital - Investigational Drug Services
      • New Haven, Connecticut, United States, 06511
        • Yale New Haven Hospital - St. Raphael campus
      • New Haven, Connecticut, United States, 06519
        • Ycci-Csru
      • New Haven, Connecticut, United States, 06878
        • Yale-New Haven Hospital Spine Center
    • Florida
      • Melbourne, Florida, United States, 32901
        • Holmes Regional Medical Center
      • Melbourne, Florida, United States, 32901
        • The B.A.C.K. Center
      • Melbourne, Florida, United States, 32935
        • Melbourne Regional Medical Center
      • Miami, Florida, United States, 33136
        • University of Miami Hospital
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics and Research Pharmacy
      • Orlando, Florida, United States, 32803
        • Florida Hospital Orlando
      • Orlando, Florida, United States, 32803
        • Neuroscience ACS Research
      • Orlando, Florida, United States, 32804
        • Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy
      • Sarasota, Florida, United States, 34232
        • Gulfcoast Research Institute, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Clinic
      • Atlanta, Georgia, United States, 30329
        • Emory Orthopaedics & Spine Center
      • Tucker, Georgia, United States, 30084
        • Emory Orthopaedics & Spine Hospital
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Bingham Memorial Hospital
      • Idaho Falls, Idaho, United States, 83404
        • Snake River Research, PLLC
      • Idaho Falls, Idaho, United States, 83404
        • Eastern Idaho Regional Medical Center
      • Idaho Falls, Idaho, United States, 83404
        • Mountain View Hospital
      • Idaho Falls, Idaho, United States, 83404
        • Bingham Memorial Specialty Clinic
      • Idaho Falls, Idaho, United States, 83404
        • Brent H. Greenwald, M.D. Neurological Surgery
      • Pocatello, Idaho, United States, 83201
        • Physicians & Surgeons Clinic
      • Pocatello, Idaho, United States, 83202
        • Bingham Memorial Family Medicine & Specialty Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60612-7232
        • University of Illinois Hospital and Health Sciences System
      • Chicago, Illinois, United States, 60612-4333
        • University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC)
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center Pharmacy
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center Professional Office Building Infusion Pharmacy
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
      • Kansas City, Kansas, United States, 66103
        • University of Kansas Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Hospital
      • Louisville, Kentucky, United States, 40202
        • Norton Leatherman Spine Center
      • Louisville, Kentucky, United States, 40202
        • Norton Healthcare Pharmacy
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70115
        • Ochsner Baptist Medical Center
      • Shreveport, Louisiana, United States, 71101-4643
        • Spine Institute of Louisiana
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • AAMC Research Pharmacy
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Health System Research Institute (AAHSRI)
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center Infusion Center
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center Laboratory
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Bayview Medical Center
      • Baltimore, Maryland, United States, 21287
        • John Hopkins Hospital
      • Baltimore, Maryland, United States, 21224
        • John Hopkins Bayview Medical Center
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Systems, Department of Neurosurgery
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Systems, Investigational Drug Services
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Medical Systems, Oriole Park
      • Baltimore, Maryland, United States, 21287
        • Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital Investigational Drug Service
      • Bowie, Maryland, United States, 20716
        • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
      • Odenton, Maryland, United States, 21113
        • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
      • Pasadena, Maryland, United States, 21122
        • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital, Clinical Research Pharmacy
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital Investigational Drug Services (IDS)
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center
      • Worcester, Massachusetts, United States, 01605
        • UMass Memorial Medical Center- Clinical Research Center
      • Worcester, Massachusetts, United States, 01605
        • University of Massachusetts Medical Center Memorial Campus
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5008
        • University of Michigan Investigational Pharmacy
      • Ann Arbor, Michigan, United States, 48109-5338
        • University Of Michigan Hospitals
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital, Heart Hospital, Harper Hospital at
      • Grand Rapids, Michigan, United States, 49503
        • Butterworth Hospital
      • Grand Rapids, Michigan, United States, 49506
        • Blodgett Hospital
      • Grand Rapids, Michigan, United States, 49525
        • Orthopaedic Associates of Michigan - Research
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, United States, 49007
        • Bronson Spine and Scoliosis Specialists
      • Rochester Hills, Michigan, United States, 48307
        • Michigan Orthopaedic & Spine Surgeons
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Orthopaedic Center
      • Southfield, Michigan, United States, 48033
        • Michigan Orthopaedic Institute
      • Troy, Michigan, United States, 48085
        • Beaumont Health-Troy
      • West Bloomfield, Michigan, United States, 48322
        • Michigan Orthopaedic Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Twin Cities Spine Surgeons dba Twin Cities Spine Center
      • Minneapolis, Minnesota, United States, 55407
        • Allina Health - Abbott Northwestern Hospital /
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Rochester, Methodist Hospital Campus
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic Hospital, Methodist Campus
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Hospital, Methodist Campus
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital
      • Saint Louis, Missouri, United States, 63108
        • Center for Outpatient Health
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Center for Advanced Medicine
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Pharmacy
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Pharmacy
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • The Rothman Institute Marlton, NJ Office
      • Montclair, New Jersey, United States, 07042
        • HackensackUMC Mountainside Hospital
      • Neptune, New Jersey, United States, 07753
        • Meridian Hospitals Corp c/o Jersey Shore University Medical Center
      • Newark, New Jersey, United States, 07103
        • University Hospital
      • Newark, New Jersey, United States, 07103
        • Ambulatory Care Center
      • Newark, New Jersey, United States, 07103
        • Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School
      • Newark, New Jersey, United States, 07103
        • Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School
      • Newark, New Jersey, United States, 07103
        • University Hospital - Pharmacy
      • Sewell, New Jersey, United States, 08080
        • The Rothman Institute Washington Township, NJ Office
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck
      • Huntington Station, New York, United States, 11746
        • NYU Langone Huntington Medical Group
      • Johnson City, New York, United States, 13790
        • UHS Wilson Medical Center
      • Johnson City, New York, United States, 13790
        • UHS Neurosurgery
      • Lynbrook, New York, United States, 11563
        • Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Manhasset, New York, United States, 11030
        • The Feinstein Institute for Medical Research
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10003
        • NYU Langone Health Orthopedic Hospital
      • New York, New York, United States, 10016
        • NYU Langone Health Orthopedic Center
      • New York, New York, United States, 10016
        • Kimmel Pavillion
      • New York, New York, United States, 10016
        • NYU Langone Health Tisch Hospital
      • New York, New York, United States, 10016
        • NYU Langone Madison Ave. Orthopedics
      • New York, New York, United States, 10029
        • lcahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10029
        • The Clinical Research Unit at Mount Sinai
      • New York, New York, United States, 10279
        • NYU Langone Seaport Orthopaedics
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Hip & Knee Center
      • Charlotte, North Carolina, United States, 28204
        • Carolina Neurosurgery and Spine Associates, P.A.
      • Charlotte, North Carolina, United States, 28207
        • Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital
      • Charlotte, North Carolina, United States, 28210
        • OrthoCarolina Pineville
      • Charlotte, North Carolina, United States, 28277
        • OrthoCarolina Ballantyne
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital, IDS Pharmacy
      • Matthews, North Carolina, United States, 28105
        • OrthoCarolina Matthews
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States, 45219
        • The Lindner Center for Research and Education at The Christ Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation - Investigation Pharmacy
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation Center for Spine Health
      • Columbus, Ohio, United States, 43215
        • Remington-Davis, Inc.
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital Pharmacy
      • Columbus, Ohio, United States, 43220
        • Orthopedic One
      • Dublin, Ohio, United States, 43016
        • Dublin Methodist Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Sciences University
      • Portland, Oregon, United States, 97239
        • OHSU Research Pharmacy
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Jefferson Health
      • Abington, Pennsylvania, United States, 19001
        • Abington Jefferson Health-Pharmacy Department
      • Chalfont, Pennsylvania, United States, 18914
        • Rothman Institute-Chalfont Office
      • Hershey, Pennsylvania, United States, 17033
        • Milton S. Hershey Medical Center Pharmacy
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Hospital For Neuroscience
      • Philadelphia, Pennsylvania, United States, 19107
        • The Rothman Institute
      • Philadelphia, Pennsylvania, United States, 19107
        • Investigational Drug Service Pharmacy
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital - Pre-Admission Testing Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital, Cardiovascular Associates
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian
      • Pittsburgh, Pennsylvania, United States, 15213
        • Upmc (Puh/Muh)
      • Willow Grove, Pennsylvania, United States, 19090
        • Rothman Institute-Willow Grove Office
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center Austin
      • Austin, Texas, United States, 78701
        • Dell Seton Medical Center at The University of Texas
      • Austin, Texas, United States, 78705
        • St. David's Medical Center
      • Austin, Texas, United States, 78731
        • Seton Spine and Scoliosis Center
      • Austin, Texas, United States, 78758
        • St. David's North Austin Medical Center
      • Austin, Texas, United States, 78705
        • Austin Infectious Disease Consultants
      • Austin, Texas, United States, 78705
        • Employee Wellness Center
      • Austin, Texas, United States, 78705
        • St. David's Neuroscience and Spine Institute
      • Austin, Texas, United States, 78758
        • Wellness Brain and Spine
      • Fredericksburg, Texas, United States, 78624
        • Neurosurgical Specialist of Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77004
        • Hermann Drive Surgical Hospital
      • Houston, Texas, United States, 77030
        • CHI St. Luke's Health Baylor College of Medicine Medical Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - McNair Campus
      • Houston, Texas, United States, 77024
        • Mermorial Hermann - Memorial City Medical Center
      • Plano, Texas, United States, 75093
        • Baylor Scott & White Medical Center
      • Round Rock, Texas, United States, 78681
        • St. David's Round Rock Medical Center
      • Round Rock, Texas, United States, 78665
        • Seton Brain and Spine Institute Williamson
      • Round Rock, Texas, United States, 78665
        • Seton Medical Center Williamson
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital And Clinic
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute)
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
      • Fairfax, Virginia, United States, 22031
        • Inova Medical Group
      • Fairfax, Virginia, United States, 22033
        • Inova Fair Oaks Hospital
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
      • Falls Church, Virginia, United States, 22042
        • Inova Neurosciences Research
      • McLean, Virginia, United States, 22102
        • OrthoVirginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Norfolk, Virginia, United States, 23510
        • Sentara Medical Group DBA Sentara Neurosurgery Specialists
      • Richamond, Virginia, United States, 23298-5028
        • VCU Medical Center Investigational Drug Service
      • Richmond, Virginia, United States, 23298
        • VCU Health
      • Richmond, Virginia, United States, 23233
        • VCU Heatlh Neuroscience Orthopedic and Wellness Center
      • Richmond, Virginia, United States, 23298
        • VCU Health Ambulatory Care Center
      • Roanoke, Virginia, United States, 24014
        • Carilion Roanoke Memorial Hospital
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic Institute for Orthopaedics and Neurosciences
      • Roanoke, Virginia, United States, 24014
        • Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S)
      • Roanoke, Virginia, United States, 24014
        • Carilion Clinic - Department of Pharmacy
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic Riverside 3
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • WVU Medicine Spine Center
      • Morgantown, West Virginia, United States, 26506-9196
        • WVU Medicine JW Ruby Memorial Hospital
      • Morgantown, West Virginia, United States, 26506
        • WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy
      • Morgantown, West Virginia, United States, 26506
        • WVU Medicine Physician Office Center Orthopaedic Surgery
      • Morgantown, West Virginia, United States, 26506
        • WVU Medicine Physician Office Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SA4Ag
Staphylococcus aureus 4-antigen Vaccine
SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery
Other Names:
  • Vaccine
Placebo Comparator: Placebo
Diluent (sterile water) for Placebo
Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Day of surgery (Day 1) up to Day 90
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
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Time Frame: 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
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination
Time Frame: 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
Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1)
Time Frame: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)
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)
Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42
Time Frame: From vaccination until Day 42 after surgery (52-102 days after vaccination)
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)
Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42
Time Frame: Day of surgery (Day 1) up to Day 42 after surgery
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
Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180
Time Frame: Day 42 up to Day 180 (up to 138 days)
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)
Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180
Time Frame: From vaccination up to Day 180 after surgery (190-240 days after vaccination)
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)
Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1)
Time Frame: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)
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)
Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180
Time Frame: Day of surgery (Day 1) up to Day 180 after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Day of surgery (Day 1) up to Day 180 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
Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 90 Days After Surgery
Time Frame: Day of surgery (Day 1) up to Day 90 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
Number of Participants With Any Postoperative S. Aureus Surgical-site Infection (SSI-Superficial, Deep Incisional or Organ/Space) Occurred Within 180 Days After Surgery
Time Frame: Day of surgery (Day 1) up to Day 180 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2015

Primary Completion (Actual)

June 26, 2019

Study Completion (Actual)

June 27, 2019

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 9, 2015

First Posted (Estimate)

March 13, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • B3451002
  • STRIVE (Alias Study Number)
  • 2014-002644-40 (EudraCT Number)
  • 6123K1-2001 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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