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

PHASE2TerminatedINTERVENTIONAL
Enrollment

3,450

Participants

Timeline

Start Date

July 2, 2015

Primary Completion Date

June 26, 2019

Study Completion Date

June 27, 2019

Conditions
Staphylococcal Vaccine
Interventions
BIOLOGICAL

Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine

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

OTHER

Placebo

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

Trial Locations (301)

1126

Orszagos Gerincgyogyaszati Kozpont, Budapest

6020

Tirol Kliniken GmbH, Innsbruck

Tirol Kliniken, Innsbruck

9010

"MHAT Sveta Marina EAD", Varna

10003

NYU Langone Health Orthopedic Hospital, New York

10016

Kimmel Pavillion, New York

NYU Langone Health Orthopedic Center, New York

NYU Langone Health Tisch Hospital, New York

NYU Langone Madison Ave. Orthopedics, New York

10021

Hospital for Special Surgery, New York

10029

Icahn School of Medicine at Mount Sinai, New York

lcahn School of Medicine at Mount Sinai, New York

The Clinical Research Unit at Mount Sinai, New York

10117

Charite- University Medicine Berlin, Berlin

10279

NYU Langone Seaport Orthopaedics, New York

11021

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

11030

North Shore University Hospital, Manhasset

The Feinstein Institute for Medical Research, Manhasset

11563

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

11746

NYU Langone Huntington Medical Group, Huntington Station

13353

Charite- University Medicine Berlin, Berlin

13385

AP-HM La Timone - Hopital adultes, Marseille

13790

UHS Neurosurgery, Johnson City

UHS Wilson Medical Center, Johnson City

13915

AP-HM Hopital Nord, Marseille

15212

Allegheny General Hospital, Pittsburgh

15213

Upmc (Puh/Muh), Pittsburgh

UPMC Presbyterian, Pittsburgh

15706

Hospital Clínico Universitario Santiago de Compostela, Santiago de Compostela

17033

Milton S. Hershey Medical Center Pharmacy, Hershey

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

18914

Rothman Institute-Chalfont Office, Chalfont

19001

Abington Jefferson Health-Pharmacy Department, Abington

Abington Jefferson Health, Abington

19090

Rothman Institute-Willow Grove Office, Willow Grove

19107

Investigational Drug Service Pharmacy, Philadelphia

Jefferson Hospital For Neuroscience, Philadelphia

The Rothman Institute, Philadelphia

Thomas Jefferson University Hospital - Pre-Admission Testing Center, Philadelphia

Thomas Jefferson University Hospital, Cardiovascular Associates, Philadelphia

Thomas Jefferson University Hospital, Philadelphia

Thomas Jefferson University, Philadelphia

19489

GHP Stockholm Spine Center, Upplands Vasby

20716

Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists, Bowie

21000

CHU de Dijon, Dijon

21079

CHU de Dijon, Dijon

CHU Hopital d'Enfants, Dijon

21113

Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists, Odenton

21122

Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists, Pasadena

21201

University of Maryland Medical Systems, Department of Neurosurgery, Baltimore

University of Maryland Medical Systems, Investigational Drug Services, Baltimore

University of Maryland, Medical Systems, Oriole Park, Baltimore

21224

John Hopkins Bayview Medical Center, Baltimore

Johns Hopkins Bayview Medical Center, Baltimore

21287

Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center, Baltimore

John Hopkins Hospital, Baltimore

The Johns Hopkins Hospital Investigational Drug Service, Baltimore

21401

AAMC Research Pharmacy, Annapolis

Anne Arundel Health System Research Institute (AAHSRI), Annapolis

Anne Arundel Medical Center Infusion Center, Annapolis

Anne Arundel Medical Center Laboratory, Annapolis

Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists, Annapolis

22003

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

22031

Inova Medical Group, Fairfax

22033

Inova Fair Oaks Hospital, Fairfax

22042

Inova Fairfax Hospital, Falls Church

Inova Neurosciences Research, Falls Church

22102

OrthoVirginia, McLean

22903

University of Virginia Health System, Charlottesville

23233

VCU Heatlh Neuroscience Orthopedic and Wellness Center, Richmond

23298

VCU Health Ambulatory Care Center, Richmond

VCU Health, Richmond

23507

Sentara Norfolk General Hospital, Norfolk

23510

Sentara Medical Group DBA Sentara Neurosurgery Specialists, Norfolk

24014

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

Carilion Clinic - Department of Pharmacy, Roanoke

Carilion Clinic Institute for Orthopaedics and Neurosciences, Roanoke

Carilion Roanoke Memorial Hospital, Roanoke

24016

Carilion Clinic Riverside 3, Roanoke

26505

WVU Medicine Spine Center, Morgantown

26506

WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy, Morgantown

WVU Medicine Physician Office Center Orthopaedic Surgery, Morgantown

WVU Medicine Physician Office Center, Morgantown

27710

Duke University Hospital, IDS Pharmacy, Durham

Duke University Hospital, Durham

28034

Hospital Ramon Y Cajal, Madrid

28105

OrthoCarolina Matthews, Matthews

28204

Carolina Neurosurgery and Spine Associates, P.A., Charlotte

28207

Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital, Charlotte

OrthoCarolina Hip & Knee Center, Charlotte

OrthoCarolina, Charlotte

28210

OrthoCarolina Pineville, Charlotte

28277

OrthoCarolina Ballantyne, Charlotte

28922

Hospital Universitario Fundacion Alcorcon, Alcorcón

30029

CHU de Nimes - Caremeau, Nîmes

CHU de Nimes, Nîmes

30084

Emory Orthopaedics & Spine Hospital, Tucker

30322

Emory University Clinic, Atlanta

30329

Emory Orthopaedics & Spine Center, Atlanta

32803

Florida Hospital Orlando, Orlando

Neuroscience ACS Research, Orlando

32804

Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy, Orlando

32901

Holmes Regional Medical Center, Melbourne

The B.A.C.K. Center, Melbourne

32935

Melbourne Regional Medical Center, Melbourne

33076

CHU Pellegrin Tripode, Bordeaux

CHU Pellegrin, Pharmacie, Bordeaux

33136

University of Miami Hospital and Clinics and Research Pharmacy, Miami

University of Miami Hospital, Miami

34232

Gulfcoast Research Institute, LLC, Sarasota

35033

CHU de Rennes - Hopital Pontchaillou, Rennes

CHU de Rennes, Rennes

Unite d'investigation clinique, Rennes

35294

The University of Alabama at Birmingham, Birmingham

40202

Norton Healthcare Pharmacy, Louisville

Norton Hospital, Louisville

Norton Leatherman Spine Center, Louisville

41013

Hospital Universitario Virgen del Rocio, Seville

42270

Hopital Nord-CHU Saint Etienne, Saint-Priest-en-Jarez

43016

Dublin Methodist Hospital, Dublin

43214

Riverside Methodist Hospital Pharmacy, Columbus

43215

Remington-Davis, Inc., Columbus

43220

Orthopedic One, Columbus

44093

CHU de Nantes - Hotel Dieu, Nantes

44195

Cleveland Clinic Foundation - Investigation Pharmacy, Cleveland

Cleveland Clinic Foundation Center for Spine Health, Cleveland

45219

The Christ Hospital, Cincinnati

The Lindner Center for Research and Education at The Christ Hospital, Cincinnati

46026

Hospital Universitario Politecnico La Fe, Valencia

47003

Pharmacy Service of Hospital Clinico de Valladolid, Valladolid

47005

Hospital Clinico Universitario de Valladolid, Valladolid

48033

Michigan Orthopaedic Institute, Southfield

48073

Beaumont Orthopaedic Center, Royal Oak

William Beaumont Hospital, Royal Oak

48085

Beaumont Health-Troy, Troy

48201

Detroit Receiving Hospital, Heart Hospital, Harper Hospital at, Detroit

48307

Michigan Orthopaedic & Spine Surgeons, Rochester Hills

48322

Michigan Orthopaedic Institute, West Bloomfield

48415

St. Franziskus Hospital Munster, Münster

49007

Bronson Methodist Hospital, Kalamazoo

Bronson Spine and Scoliosis Specialists, Kalamazoo

49503

Butterworth Hospital, Grand Rapids

49506

Blodgett Hospital, Grand Rapids

49525

Orthopaedic Associates of Michigan - Research, Grand Rapids

50937

Uniklinik Koeln, Cologne

52242

University of Iowa Hospitals and Clinics, Iowa City

55404

Twin Cities Spine Surgeons dba Twin Cities Spine Center, Minneapolis

55407

Allina Health - Abbott Northwestern Hospital /, Minneapolis

55902

Mayo Clinic Hospital, Methodist Campus, Rochester

Mayo Clinic Rochester, Methodist Hospital Campus, Rochester

55905

Mayo Clinic Hospital, Methodist Campus, Rochester

Mayo Clinic, Rochester

60612

Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC), Chicago

Rush University Medical Center Pharmacy, Chicago

Rush University Medical Center Professional Office Building Infusion Pharmacy, Chicago

Rush University Medical Center, Chicago

63108

Center for Outpatient Health, St Louis

63110

Barnes Jewish Center for Advanced Medicine, St Louis

Barnes Jewish Hospital, St Louis

Barnes Jewish Pharmacy, St Louis

Barnes-Jewish Pharmacy, St Louis

Washington University, St Louis

66103

University of Kansas Hospital, Kansas City

66160

University of Kansas Medical Center, Kansas City

67091

Hopital Civil, Strasbourg

67200

Hopitaux Universitaires de Strasbourg, Strasbourg

70115

Ochsner Baptist Medical Center, New Orleans

70121

Ochsner Clinic Foundation, New Orleans

75014

CIC Cochin/Pasteur (CIC 1417), Paris

Service de Chirurgie Orthopedique et Traumatologie, Paris

Service de Pharmacie, Paris

75093

Baylor Scott & White Medical Center, Plano

76508

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

Scott & White Memorial Hospital and Clinic, Temple

Scott & White Memorial Hospital, Temple

77004

Hermann Drive Surgical Hospital, Houston

77024

Mermorial Hermann - Memorial City Medical Center, Houston

77030

Baylor College of Medicine - McNair Campus, Houston

Baylor College of Medicine, Houston

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

78624

Neurosurgical Specialist of Texas, Fredericksburg

78665

Seton Brain and Spine Institute Williamson, Round Rock

Seton Medical Center Williamson, Round Rock

78681

St. David's Round Rock Medical Center, Round Rock

78701

Dell Seton Medical Center at The University of Texas, Austin

78705

Austin Infectious Disease Consultants, Austin

Employee Wellness Center, Austin

Seton Medical Center Austin, Austin

St. David's Medical Center, Austin

St. David's Neuroscience and Spine Institute, Austin

78731

Seton Spine and Scoliosis Center, Austin

78758

St. David's North Austin Medical Center, Austin

Wellness Brain and Spine, Austin

80045

University of Colorado Clinical & Translational Research Center Clinic, Aurora

University of Colorado Denver, School of Medicine, Aurora

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

University of Colorado Hospital, Aurora

80124

University of Colorado Hospital, Lone Tree Health Center, Lone Tree

80303

Boulder Community Health - Foothills Hospital, Boulder

Boulder Community Health, Boulder

Justin Parker Neurological Institute, Boulder

81675

Klinikum rechts der Isar, Technische Universitat Munchen, München

Klinikum rechts der Isar, München

83201

Physicians & Surgeons Clinic, Pocatello

83202

Bingham Memorial Family Medicine & Specialty Clinic, Pocatello

83221

Bingham Memorial Hospital, Blackfoot

83404

Bingham Memorial Specialty Clinic, Idaho Falls

Brent H. Greenwald, M.D. Neurological Surgery, Idaho Falls

Eastern Idaho Regional Medical Center, Idaho Falls

Mountain View Hospital, Idaho Falls

Snake River Research, PLLC, Idaho Falls

85013

Barrow Brain and Spine, Phoenix

St. Joseph's Hospital and Medical Center, Phoenix

85251

Greenbaum Surgical Specialty Hospital, Scottsdale

HonorHealth Scottsdale Osborn Medical Center, Scottsdale

89102

University Medical Center of Southern Nevada, Las Vegas

90033

IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital, Los Angeles

Keck Hospital of USC, Los Angeles

USC Spine Center, Los Angeles

USC/Department of Neurological Surgery, Los Angeles

90048

Cedars-Sinai Medical Center - Investigational Drug, Los Angeles

Cedars-Sinai Medical Center, Los Angeles

Clinical Office, Los Angeles

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

90095

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

Ronald Reagan UCLA Medical Center, Los Angeles

UCLA CTRC Outpatient Unit, Los Angeles

90210

Clinical Office - Jason Cuellar M.D., Beverly Hills

90401

UCLA Spine Center, Santa Monica

90404

Santa Monica UCLA Medical Center & Orthopaedic Hospital, Santa Monica

UCLA Santa Monica Infectious Disease, Santa Monica

90502

LA BioMed at Harbor-UCLA Medical Center, Torrance

LA BioMed, Harbor-UCLA Medical Center, Torrance

90509

Harbor-UCLA Medical Center, Torrance

LA BioMed at Harbor-UCLA Medical Center, Torrance

90806

Memorial Orthopaedic Surgical Group, Long Beach

92868

University of California Irvine Medical Center, Orange

94143

University of California, San Francisco, San Francisco

94611

Kaiser Permanente Pediatric Clinic, Oakland

94612

Kaiser Permanente Vaccine Study Center, Oakland

97239

OHSU Research Pharmacy, Portland

Oregon Health and Sciences University, Portland

98101

Virginia Mason Medical Center, Seattle

06510

Yale New Haven Hospital - Investigational Drug Services, New Haven

Yale New Haven Hospital, New Haven

06511

Yale New Haven Hospital - St. Raphael campus, New Haven

06519

Ycci-Csru, New Haven

06878

Yale-New Haven Hospital Spine Center, New Haven

60612-4333

University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services, Chicago

60612-7232

University of Illinois Hospital and Health Sciences System, Chicago

71101-4643

Spine Institute of Louisiana, Shreveport

02114

Massachusetts General Hospital, Clinical Research Pharmacy, Boston

Massachusetts General Hospital, Boston

02115

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

Brigham and Women's Hospital, Boston

01605

UMass Memorial Medical Center- Clinical Research Center, Worcester

UMass Memorial Medical Center, Worcester

University of Massachusetts Medical Center Memorial Campus, Worcester

48109-5008

University of Michigan Investigational Pharmacy, Ann Arbor

48109-5338

University Of Michigan Hospitals, Ann Arbor

08053

The Rothman Institute Marlton, NJ Office, Marlton

07042

HackensackUMC Mountainside Hospital, Montclair

07753

Meridian Hospitals Corp c/o Jersey Shore University Medical Center, Neptune City

07103

Ambulatory Care Center, Newark

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

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

University Hospital - Pharmacy, Newark

University Hospital, Newark

08080

The Rothman Institute Washington Township, NJ Office, Sewell

23298-5028

VCU Medical Center Investigational Drug Service, Richamond

26506-9196

WVU Medicine JW Ruby Memorial Hospital, Morgantown

T2N 2T9

Foothills Medical Centre, Calgary

T2N 4Z6

Foothills Medical Centre, University of Calgary, Calgary

K1Y 4E9

The Ottawa Hospital, Civic Campus, Ottawa

M5B 1M4

St. Michael's Hospital, Toronto

M5B 1W8

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

St. Michael's Hospital, Toronto

M5T 2S8

Toronto Western Hospital, Toronto

H3A 2B4

Montreal Neurological Hospital Research Pharmacy, Montreal

Montreal Neurological Institute and Hospital, Montreal

H3G 1A4

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

040-8585

Hakodate Central General Hospital, Hakodate

063-0005

National Hospital Organization Hokkaido Medical Center, Sapporo

211-8510

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

857-0134

Nagasaki Rosai Hospital, Sasebo

332-8558

Saiseikai Kawaguchi General Hospital, Kawaguchi

430-8558

Seirei Hamamatsu General Hospital, Hamamatsu

208-0011

National Hospital Organization Murayama Medical Center, Musashimurayama

180-8610

Musashino Red Cross Hospital, Musashino

750-8520

Shimonoseki City Hospital, Shimonoseki-shi

553-0003

Japan Community Health care Organization Osaka Hospital, Osaka

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

TS4 3BW

Pharmacy Store, Main Pharmacy, Middlesbrough

Pharmacy Store, Middlesbrough

South Tees Hospitals NHS Foundation Trust, Middlesbrough

The James Cook University Hospital, Middlesbrough

M6 8HD

Salford Royal NHS Foundation Trust, Salford

NG7 2UH

Centre for Spinal Studies and Surgery, Nottingham

SO16 6YD

Southampton General Hospital, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT02388165 - Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation | Biotech Hunter | Biotech Hunter