AzTrials
AzTrials

Staphylococcal VaccinePhase 2STRIVENCT02388165

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

A Phase 2 study testing Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine in people with Staphylococcal Vaccine, run by Pfizer at 301 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Staphylococcal Vaccine
What is being tested?
Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,450 participants
Where
301 sitesin 11 countries
Study dates
2 Jul 2015to 27 Jun 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

301 sites in 11 countries.

301 sites in 11 countries

United States234 sites

  • Abington Jefferson Health-Pharmacy Department

    Abington, Pennsylvania, 19001

  • Abington Jefferson Health

    Abington, Pennsylvania, 19001

  • University of Michigan Investigational Pharmacy

    Ann Arbor, Michigan, 48109-5008

  • University Of Michigan Hospitals

    Ann Arbor, Michigan, 48109-5338

  • Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)

    Annandale, Virginia, 22003

  • AAMC Research Pharmacy

    Annapolis, Maryland, 21401

  • Anne Arundel Health System Research Institute (AAHSRI)

    Annapolis, Maryland, 21401

  • Anne Arundel Medical Center Infusion Center

    Annapolis, Maryland, 21401

  • Anne Arundel Medical Center Laboratory

    Annapolis, Maryland, 21401

  • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists

    Annapolis, Maryland, 21401

  • Emory University Clinic

    Atlanta, Georgia, 30322

  • Emory Orthopaedics & Spine Center

    Atlanta, Georgia, 30329

  • University of Colorado Clinical & Translational Research Center Clinic

    Aurora, Colorado, 80045

  • University of Colorado Denver, School of Medicine

    Aurora, Colorado, 80045

  • University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage

    Aurora, Colorado, 80045

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Dell Seton Medical Center at The University of Texas

    Austin, Texas, 78701

  • Austin Infectious Disease Consultants

    Austin, Texas, 78705

  • Employee Wellness Center

    Austin, Texas, 78705

  • Seton Medical Center Austin

    Austin, Texas, 78705

  • St. David's Medical Center

    Austin, Texas, 78705

  • St. David's Neuroscience and Spine Institute

    Austin, Texas, 78705

  • Seton Spine and Scoliosis Center

    Austin, Texas, 78731

  • St. David's North Austin Medical Center

    Austin, Texas, 78758

  • Wellness Brain and Spine

    Austin, Texas, 78758

  • University of Maryland Medical Systems, Department of Neurosurgery

    Baltimore, Maryland, 21201

  • University of Maryland Medical Systems, Investigational Drug Services

    Baltimore, Maryland, 21201

  • University of Maryland, Medical Systems, Oriole Park

    Baltimore, Maryland, 21201

  • John Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center

    Baltimore, Maryland, 21287

  • John Hopkins Hospital

    Baltimore, Maryland, 21287

  • The Johns Hopkins Hospital Investigational Drug Service

    Baltimore, Maryland, 21287

  • Clinical Office - Jason Cuellar M.D.

    Beverly Hills, California, 90210

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Bingham Memorial Hospital

    Blackfoot, Idaho, 83221

  • Massachusetts General Hospital, Clinical Research Pharmacy

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital Investigational Drug Services (IDS)

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boulder Community Health - Foothills Hospital

    Boulder, Colorado, 80303

  • Boulder Community Health

    Boulder, Colorado, 80303

  • Justin Parker Neurological Institute

    Boulder, Colorado, 80303

  • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists

    Bowie, Maryland, 20716

  • Rothman Institute-Chalfont Office

    Chalfont, Pennsylvania, 18914

  • Carolina Neurosurgery and Spine Associates, P.A.

    Charlotte, North Carolina, 28204

  • Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital

    Charlotte, North Carolina, 28207

  • OrthoCarolina Hip & Knee Center

    Charlotte, North Carolina, 28207

  • OrthoCarolina

    Charlotte, North Carolina, 28207

  • OrthoCarolina Pineville

    Charlotte, North Carolina, 28210

  • OrthoCarolina Ballantyne

    Charlotte, North Carolina, 28277

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services

    Chicago, Illinois, 60612-4333

  • University of Illinois Hospital and Health Sciences System

    Chicago, Illinois, 60612-7232

  • Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC)

    Chicago, Illinois, 60612

  • Rush University Medical Center Pharmacy

    Chicago, Illinois, 60612

  • Rush University Medical Center Professional Office Building Infusion Pharmacy

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • The Lindner Center for Research and Education at The Christ Hospital

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation - Investigation Pharmacy

    Cleveland, Ohio, 44195

  • Cleveland Clinic Foundation Center for Spine Health

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital Pharmacy

    Columbus, Ohio, 43214

  • Remington-Davis, Inc.

    Columbus, Ohio, 43215

  • Orthopedic One

    Columbus, Ohio, 43220

  • Detroit Receiving Hospital, Heart Hospital, Harper Hospital at

    Detroit, Michigan, 48201

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Duke University Hospital, IDS Pharmacy

    Durham, North Carolina, 27710

  • Duke University Hospital

    Durham, North Carolina, 27710

  • Inova Medical Group

    Fairfax, Virginia, 22031

  • Inova Fair Oaks Hospital

    Fairfax, Virginia, 22033

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Inova Neurosciences Research

    Falls Church, Virginia, 22042

  • Neurosurgical Specialist of Texas

    Fredericksburg, Texas, 78624

  • Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Blodgett Hospital

    Grand Rapids, Michigan, 49506

  • Orthopaedic Associates of Michigan - Research

    Grand Rapids, Michigan, 49525

  • Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck

    Great Neck, New York, 11021

  • Milton S. Hershey Medical Center Pharmacy

    Hershey, Pennsylvania, 17033

  • Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Hermann Drive Surgical Hospital

    Houston, Texas, 77004

  • Mermorial Hermann - Memorial City Medical Center

    Houston, Texas, 77024

  • Baylor College of Medicine - McNair Campus

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas, 77030

  • CHI St. Luke's Health Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • NYU Langone Huntington Medical Group

    Huntington Station, New York, 11746

  • Bingham Memorial Specialty Clinic

    Idaho Falls, Idaho, 83404

  • Brent H. Greenwald, M.D. Neurological Surgery

    Idaho Falls, Idaho, 83404

  • Eastern Idaho Regional Medical Center

    Idaho Falls, Idaho, 83404

  • Mountain View Hospital

    Idaho Falls, Idaho, 83404

  • Snake River Research, PLLC

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • UHS Neurosurgery

    Johnson City, New York, 13790

  • UHS Wilson Medical Center

    Johnson City, New York, 13790

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Bronson Spine and Scoliosis Specialists

    Kalamazoo, Michigan, 49007

  • University of Kansas Hospital

    Kansas City, Kansas, 66103

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • University of Colorado Hospital, Lone Tree Health Center

    Lone Tree, Colorado, 80124

  • Memorial Orthopaedic Surgical Group

    Long Beach, California, 90806

  • IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • USC Spine Center

    Los Angeles, California, 90033

  • USC/Department of Neurological Surgery

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center - Investigational Drug

    Los Angeles, California, 90048

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Clinical Office

    Los Angeles, California, 90048

  • The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Ronald Reagan Med Center - University of California, Los Angeles (UCLA)

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA CTRC Outpatient Unit

    Los Angeles, California, 90095

  • Norton Healthcare Pharmacy

    Louisville, Kentucky, 40202

  • Norton Hospital

    Louisville, Kentucky, 40202

  • Norton Leatherman Spine Center

    Louisville, Kentucky, 40202

  • Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook

    Lynbrook, New York, 11563

  • North Shore University Hospital

    Manhasset, New York, 11030

  • The Feinstein Institute for Medical Research

    Manhasset, New York, 11030

  • The Rothman Institute Marlton, NJ Office

    Marlton, New Jersey, 08053

  • OrthoCarolina Matthews

    Matthews, North Carolina, 28105

  • OrthoVirginia

    McLean, Virginia, 22102

  • Holmes Regional Medical Center

    Melbourne, Florida, 32901

  • The B.A.C.K. Center

    Melbourne, Florida, 32901

  • Melbourne Regional Medical Center

    Melbourne, Florida, 32935

  • University of Miami Hospital and Clinics and Research Pharmacy

    Miami, Florida, 33136

  • University of Miami Hospital

    Miami, Florida, 33136

  • Twin Cities Spine Surgeons dba Twin Cities Spine Center

    Minneapolis, Minnesota, 55404

  • Allina Health - Abbott Northwestern Hospital /

    Minneapolis, Minnesota, 55407

  • HackensackUMC Mountainside Hospital

    Montclair, New Jersey, 07042

  • WVU Medicine Spine Center

    Morgantown, West Virginia, 26505

  • WVU Medicine JW Ruby Memorial Hospital

    Morgantown, West Virginia, 26506-9196

  • WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy

    Morgantown, West Virginia, 26506

  • WVU Medicine Physician Office Center Orthopaedic Surgery

    Morgantown, West Virginia, 26506

  • WVU Medicine Physician Office Center

    Morgantown, West Virginia, 26506

  • Meridian Hospitals Corp c/o Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Yale New Haven Hospital - Investigational Drug Services

    New Haven, Connecticut, 06510

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale New Haven Hospital - St. Raphael campus

    New Haven, Connecticut, 06511

  • Ycci-Csru

    New Haven, Connecticut, 06519

  • Yale-New Haven Hospital Spine Center

    New Haven, Connecticut, 06878

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Langone Health Orthopedic Hospital

    New York, New York, 10003

  • Kimmel Pavillion

    New York, New York, 10016

  • NYU Langone Health Orthopedic Center

    New York, New York, 10016

  • NYU Langone Health Tisch Hospital

    New York, New York, 10016

  • NYU Langone Madison Ave. Orthopedics

    New York, New York, 10016

  • Hospital for Special Surgery

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • lcahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • The Clinical Research Unit at Mount Sinai

    New York, New York, 10029

  • NYU Langone Seaport Orthopaedics

    New York, New York, 10279

  • Ambulatory Care Center

    Newark, New Jersey, 07103

  • Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School

    Newark, New Jersey, 07103

  • Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School

    Newark, New Jersey, 07103

  • University Hospital - Pharmacy

    Newark, New Jersey, 07103

  • University Hospital

    Newark, New Jersey, 07103

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • Sentara Medical Group DBA Sentara Neurosurgery Specialists

    Norfolk, Virginia, 23510

  • Kaiser Permanente Pediatric Clinic

    Oakland, California, 94611

  • Kaiser Permanente Vaccine Study Center

    Oakland, California, 94612

  • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists

    Odenton, Maryland, 21113

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Neuroscience ACS Research

    Orlando, Florida, 32803

  • Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy

    Orlando, Florida, 32804

  • Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists

    Pasadena, Maryland, 21122

  • Investigational Drug Service Pharmacy

    Philadelphia, Pennsylvania, 19107

  • Jefferson Hospital For Neuroscience

    Philadelphia, Pennsylvania, 19107

  • The Rothman Institute

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital - Pre-Admission Testing Center

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital, Cardiovascular Associates

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Barrow Brain and Spine

    Phoenix, Arizona, 85013

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Upmc (Puh/Muh)

    Pittsburgh, Pennsylvania, 15213

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Baylor Scott & White Medical Center

    Plano, Texas, 75093

  • Physicians & Surgeons Clinic

    Pocatello, Idaho, 83201

  • Bingham Memorial Family Medicine & Specialty Clinic

    Pocatello, Idaho, 83202

  • OHSU Research Pharmacy

    Portland, Oregon, 97239

  • Oregon Health and Sciences University

    Portland, Oregon, 97239

  • VCU Medical Center Investigational Drug Service

    Richamond, Virginia, 23298-5028

  • VCU Heatlh Neuroscience Orthopedic and Wellness Center

    Richmond, Virginia, 23233

  • VCU Health Ambulatory Care Center

    Richmond, Virginia, 23298

  • VCU Health

    Richmond, Virginia, 23298

  • Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S)

    Roanoke, Virginia, 24014

  • Carilion Clinic - Department of Pharmacy

    Roanoke, Virginia, 24014

  • Carilion Clinic Institute for Orthopaedics and Neurosciences

    Roanoke, Virginia, 24014

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014

  • Carilion Clinic Riverside 3

    Roanoke, Virginia, 24016

  • Mayo Clinic Hospital, Methodist Campus

    Rochester, Minnesota, 55902

  • Mayo Clinic Rochester, Methodist Hospital Campus

    Rochester, Minnesota, 55902

  • Mayo Clinic Hospital, Methodist Campus

    Rochester, Minnesota, 55905

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Michigan Orthopaedic & Spine Surgeons

    Rochester Hills, Michigan, 48307

  • Seton Brain and Spine Institute Williamson

    Round Rock, Texas, 78665

  • Seton Medical Center Williamson

    Round Rock, Texas, 78665

  • St. David's Round Rock Medical Center

    Round Rock, Texas, 78681

  • Beaumont Orthopaedic Center

    Royal Oak, Michigan, 48073

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • University of California, San Francisco

    San Francisco, California, 94143

  • UCLA Spine Center

    Santa Monica, California, 90401

  • Santa Monica UCLA Medical Center & Orthopaedic Hospital

    Santa Monica, California, 90404

  • UCLA Santa Monica Infectious Disease

    Santa Monica, California, 90404

  • Gulfcoast Research Institute, LLC

    Sarasota, Florida, 34232

  • Greenbaum Surgical Specialty Hospital

    Scottsdale, Arizona, 85251

  • HonorHealth Scottsdale Osborn Medical Center

    Scottsdale, Arizona, 85251

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • The Rothman Institute Washington Township, NJ Office

    Sewell, New Jersey, 08080

  • Spine Institute of Louisiana

    Shreveport, Louisiana, 71101-4643

  • Michigan Orthopaedic Institute

    Southfield, Michigan, 48033

  • Center for Outpatient Health

    St Louis, Missouri, 63108

  • Barnes Jewish Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Barnes Jewish Pharmacy

    St Louis, Missouri, 63110

  • Barnes-Jewish Pharmacy

    St Louis, Missouri, 63110

  • Washington University

    St Louis, Missouri, 63110

  • Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute)

    Temple, Texas, 76508

  • Scott & White Memorial Hospital and Clinic

    Temple, Texas, 76508

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • LA BioMed at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • LA BioMed, Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Harbor-UCLA Medical Center

    Torrance, California, 90509

  • LA BioMed at Harbor-UCLA Medical Center

    Torrance, California, 90509

  • Beaumont Health-Troy

    Troy, Michigan, 48085

  • Emory Orthopaedics & Spine Hospital

    Tucker, Georgia, 30084

  • Michigan Orthopaedic Institute

    West Bloomfield, Michigan, 48322

  • Rothman Institute-Willow Grove Office

    Willow Grove, Pennsylvania, 19090

  • UMass Memorial Medical Center- Clinical Research Center

    Worcester, Massachusetts, 01605

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

  • University of Massachusetts Medical Center Memorial Campus

    Worcester, Massachusetts, 01605

Other trials in United States

France19 sites

  • CHU Pellegrin Tripode

    Bordeaux, 33076

  • CHU Pellegrin, Pharmacie

    Bordeaux, 33076

  • CHU de Dijon

    Dijon, 21000

  • CHU de Dijon

    Dijon, 21079

  • CHU Hopital d'Enfants

    Dijon, 21079

  • AP-HM La Timone - Hopital adultes

    Marseille, 13385

  • AP-HM Hopital Nord

    Marseille, 13915

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

  • CHU de Nimes - Caremeau

    Nîmes, 30029

  • CHU de Nimes

    Nîmes, 30029

  • CIC Cochin/Pasteur (CIC 1417)

    Paris, 75014

  • Service de Chirurgie Orthopedique et Traumatologie

    Paris, 75014

  • Service de Pharmacie

    Paris, 75014

  • CHU de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • CHU de Rennes

    Rennes, 35033

  • Unite d'investigation clinique

    Rennes, 35033

  • Hopital Nord-CHU Saint Etienne

    Saint-Priest-en-Jarez, 42270

  • Hopital Civil

    Strasbourg, 67091

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67200

Other trials in France

Canada10 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Foothills Medical Centre, University of Calgary

    Calgary, Alberta, T2N 4Z6

  • Montreal Neurological Hospital Research Pharmacy

    Montreal, Quebec, H3A 2B4

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4

  • Montreal General Hospital Research Institute of the MUHC- MGH Pharmacy Research

    Montreal, Quebec, H3G 1A4

  • The Ottawa Hospital, Civic Campus

    Ottawa, Ontario, K1Y 4E9

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1M4

  • St, Michael's Hospital - St. Michael's Pharmacy

    Toronto, Ontario, M5B 1W8

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Japan10 sites

  • Hakodate Central General Hospital

    Hakodate, Hokkaido, 040-8585

  • Seirei Hamamatsu General Hospital

    Hamamatsu, Shizuoka, 430-8558

  • Saiseikai Kawaguchi General Hospital

    Kawaguchi, Saitama, 332-8558

  • Japan Organization of Occupational Health and Safety, Kanto Rosai Hospital

    Kawasaki, Kanagawa, 211-8510

  • National Hospital Organization Murayama Medical Center

    Musashimurayama, Tokyo, 208-0011

  • Musashino Red Cross Hospital

    Musashino, Tokyo, 180-8610

  • Japan Community Health care Organization Osaka Hospital

    Osaka, 553-0003

  • National Hospital Organization Hokkaido Medical Center

    Sapporo, Hokkaido, 063-0005

  • Nagasaki Rosai Hospital

    Sasebo, Nagasaki, 857-0134

  • Shimonoseki City Hospital

    Shimonoseki-shi, Yamaguchi, 750-8520

Other trials in Japan

Spain10 sites

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Ramon Y Cajal

    Madrid, 28034

  • Hospital Clínico Universitario Santiago de Compostela

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Politecnico La Fe

    Valencia, 46026

  • Pharmacy Service of Hospital Clinico de Valladolid

    Valladolid, 47003

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005

Other trials in Spain

United Kingdom7 sites

  • Pharmacy Store, Main Pharmacy

    Middlesbrough, Cleveland, TS4 3BW

  • Pharmacy Store

    Middlesbrough, Cleveland, TS4 3BW

  • South Tees Hospitals NHS Foundation Trust

    Middlesbrough, Cleveland, TS4 3BW

  • The James Cook University Hospital

    Middlesbrough, Cleveland, TS4 3BW

  • Centre for Spinal Studies and Surgery

    Nottingham, NG7 2UH

  • Salford Royal NHS Foundation Trust

    Salford, Greater Manchester, M6 8HD

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Germany6 sites

  • Charite- University Medicine Berlin

    Berlin, 10117

  • Charite- University Medicine Berlin

    Berlin, 13353

  • Uniklinik Koeln

    Cologne, 50937

  • Klinikum rechts der Isar, Technische Universitat Munchen

    München, 81675

  • Klinikum rechts der Isar

    München, 81675

  • St. Franziskus Hospital Munster

    Münster, 48415

Other trials in Germany

Austria2 sites

  • Tirol Kliniken GmbH

    Innsbruck, 6020

  • Tirol Kliniken

    Innsbruck, 6020

Other trials in Austria

Bulgaria1 site

  • MHAT "Sveta Marina" EAD

    Varna, 9010

Other trials in Bulgaria

Hungary1 site

  • Orszagos Gerincgyogyaszati Kozpont

    Budapest, 1126

Other trials in Hungary

Sweden1 site

  • GHP Stockholm Spine Center

    Upplands Vasby, 19489

Other trials in Sweden

About this study

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

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.

Being tested
Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine, Placebo
Keywords
Staphylococcal Vaccine, Post-operative Surgical Site Infection, Spinal Surgery, MRSA, Staphylococcus aureus
Medical subject headings
Staphylococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Staphylococcus aureus 4-Antigen (SA4Ag) VaccineBiological

    Also called Vaccine

    SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery

  • PlaceboOther

    Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery

Study groups in NCT02388165
Study groupRoleWhat they receive
SA4AgActive comparatorStaphylococcus aureus 4-antigen Vaccine
Receives: Biological: Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
PlaceboPlacebo comparatorDiluent (sterile water) for Placebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Day of surgery (Day 1) up to Day 90

  2. 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.

    Measured: Within 10 days after Vaccination

  3. 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.

    Measured: Within 10 days after Vaccination

  4. 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.

    Measured: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)

  5. 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.

    Measured: From vaccination until Day 42 after surgery (52-102 days after vaccination)

  6. 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.

    Measured: Day of surgery (Day 1) up to Day 42 after surgery

  7. 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.

    Measured: Day 42 up to Day 180 (up to 138 days)

  8. 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.

    Measured: From vaccination up to Day 180 after surgery (190-240 days after vaccination)

  9. 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.

    Measured: From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)

  10. 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.

    Measured: Day of surgery (Day 1) up to Day 180 after surgery

Secondary outcomes (3)

  1. 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).

    Measured: Day of surgery (Day 1) up to Day 180 after surgery

  2. 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.

    Measured: Day of surgery (Day 1) up to Day 90 after surgery

  3. 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.

    Measured: Day of surgery (Day 1) up to Day 180 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2015 (estimated)
  2. Study start2 Jul 2015
  3. Primary completion26 Jun 2019
  4. Study completion27 Jun 2019

Why it stopped: Study terminated by sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
3,450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02388165
Sponsor's protocol ID
B3451002
Other IDs
2014-002644-40, 6123K1-2001, STRIVE, 2014
Acronym
STRIVE
Status last verified
Nov 2020
First submitted
9 Mar 2015
Last updated
5 Jan 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Hassanzadeh H, Baber J, Begier E, Noriega DC, Konishi H, Yato Y, Wang MY, Le Huec JC, Patel V, Varga P, Liljenqvist U, Conly J, Sabharwal C, Munjal I, Cooper D, Radley D, Jaques A, Patton M, Gruber WC, Jansen KU, Anderson AS, Gurtman A; STaphylococcus aureus suRgical Inpatient Vaccine Efficacy Investigator Team. Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial. Clin Infect Dis. 2023 Jul 26;77(2):312-320. doi: 10.1093/cid/ciad218.

    PubMed 37125490

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine in people with Staphylococcal Vaccine, run by Pfizer at 301 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 301 sites in United States, France, Canada, Japan, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Day of surgery (Day 1) up to Day 90). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02388165, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.

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