Study Stopped
Study terminated by sponsor
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
STRIVE
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
4 other identifiers
interventional
3,450
11 countries
301
Brief Summary
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of SA4Ag in patients who are undergoing elective spinal surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
Typical duration for phase_2
301 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedStudy Start
First participant enrolled
July 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2019
CompletedResults Posted
Study results publicly available
September 2, 2020
CompletedJanuary 5, 2021
November 1, 2020
4 years
March 9, 2015
June 5, 2020
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Number of Participants With Postoperative Staphylococcus (S.) Aureus Bloodstream Infection (BSI) And/or Surgical-site Infection (SSI-Including Deep Incisional or Organ/Space) Occurred Within 90 Days After Spinal Surgery
BSI: clinical infection involved a recognized pathogen (S. aureus) cultured from 1 or more blood cultures or a commensal organism cultured from 2 or more blood cultures whether primary or secondary to infection at another site. SSI: infection at a surgical incision. Types of SSI in this outcome measure: Deep incisional SSI: infection involved deep soft tissues of incision (example \[e.g.\] fascial and muscle layers), Organ/space SSI: infection involved any part of body excluding skin incision, fascia or muscle layers, that was opened or manipulated during operative procedure. Overall number of participants with postoperative BSI and/or SSI (including deep incisional or organ/space), caused by S. aureus, occurred within 90 days of post elective open posterior spinal fusion surgery with multilevel instrumentation, as confirmed by event adjudication committee (EAC) have been reported. A participant may have met criteria for both BSI and SSI (deep incisional or organ/space).
Day of surgery (Day 1) up to Day 90
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were categorized as mild (2.5 to 5.0 centimeters \[cm\]), moderate (5.5 to 10.0 cm) and, severe (greater than or equal to \[\>=\] 10.5 cm). Pain at the injection site was defined as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling, pain at the injection site represents any grade of these local reactions among mild, moderate or severe.
Within 10 days after Vaccination
Percentage of Participants With Systemic Reactions Within 10 Days After Vaccination
Systemic reactions included fever, fatigue, headache, diarrhea, vomiting, muscle pain and joint pain, were recorded using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and greater than (\>) 40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (prevented daily routine activity). Participants may be represented in more than 1 row. Here "any" for fever, fatigue, headache, vomiting, diarrhea, muscle pain, joint pain represents any grade of these systemic reactions among mild, moderate or severe.
Within 10 days after Vaccination
Number of Participants With Adverse Events (AEs) From Vaccination Until The Day of Surgery (Day 1)
An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.
From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)
Number of Participants With Adverse Events (AEs) From Vaccination Until First Postoperative Evaluation on Day 42
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.
From vaccination until Day 42 after surgery (52-102 days after vaccination)
Number of Participants With Adverse Events (AEs) From The Day of Surgery (Day 1) Until First Postoperative Evaluation on Day 42
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. AEs including serious as well non-serious AEs.
Day of surgery (Day 1) up to Day 42 after surgery
Number of Participants With Newly Diagnosed Chronic Medical Disorders From First Postoperative Evaluation on Day 42 Until Last Postoperative Evaluation on Day 180
A newly diagnosed chronic medical disorder was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Day 42 up to Day 180 (up to 138 days)
Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Last Postoperative Evaluation on Day 180
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.
From vaccination up to Day 180 after surgery (190-240 days after vaccination)
Number of Participants With Serious Adverse Events (SAEs) From Vaccination Until Day of Surgery (Day 1)
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.
From vaccination up to Day of surgery (Day 1) (10-60 days after vaccination)
Number of Participants With Serious Adverse Events (SAEs) From The Day of Surgery (Day 1) Until Last Postoperative Evaluation on Day 180
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly.
Day of surgery (Day 1) up to Day 180 after surgery
Secondary Outcomes (3)
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
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
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
Day of surgery (Day 1) up to Day 180 after surgery
Study Arms (2)
SA4Ag
ACTIVE COMPARATORStaphylococcus aureus 4-antigen Vaccine
Placebo
PLACEBO COMPARATORDiluent (sterile water) for Placebo
Interventions
SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery
Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (301)
The University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Barrow Brain and Spine
Phoenix, Arizona, 85013, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Greenbaum Surgical Specialty Hospital
Scottsdale, Arizona, 85251, United States
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251, United States
Clinical Office - Jason Cuellar M.D.
Beverly Hills, California, 90210, United States
Memorial Orthopaedic Surgical Group
Long Beach, California, 90806, United States
IDS Pharmacy-USC Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
USC Spine Center
Los Angeles, California, 90033, United States
USC/Department of Neurological Surgery
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center - Investigational Drug
Los Angeles, California, 90048, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Clinical Office
Los Angeles, California, 90048, United States
The Spine Center at Cedars-Sinai, Mark Goodson Building, Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Ronald Reagan Med Center - University of California, Los Angeles (UCLA)
Los Angeles, California, 90095, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA CTRC Outpatient Unit
Los Angeles, California, 90095, United States
Kaiser Permanente Pediatric Clinic
Oakland, California, 94611, United States
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612, United States
University of California Irvine Medical Center
Orange, California, 92868, United States
University of California, San Francisco
San Francisco, California, 94143, United States
UCLA Spine Center
Santa Monica, California, 90401, United States
Santa Monica UCLA Medical Center & Orthopaedic Hospital
Santa Monica, California, 90404, United States
UCLA Santa Monica Infectious Disease
Santa Monica, California, 90404, United States
LA BioMed at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
LA BioMed, Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Harbor-UCLA Medical Center
Torrance, California, 90509, United States
LA BioMed at Harbor-UCLA Medical Center
Torrance, California, 90509, United States
University of Colorado Clinical & Translational Research Center Clinic
Aurora, Colorado, 80045, United States
University of Colorado Denver, School of Medicine
Aurora, Colorado, 80045, United States
University of Colorado Department of Pharmacy AIP 2, Pharmacy Bulk Storage
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Boulder Community Health - Foothills Hospital
Boulder, Colorado, 80303, United States
Boulder Community Health
Boulder, Colorado, 80303, United States
Justin Parker Neurological Institute
Boulder, Colorado, 80303, United States
University of Colorado Hospital, Lone Tree Health Center
Lone Tree, Colorado, 80124, United States
Yale New Haven Hospital - Investigational Drug Services
New Haven, Connecticut, 06510, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale New Haven Hospital - St. Raphael campus
New Haven, Connecticut, 06511, United States
Ycci-Csru
New Haven, Connecticut, 06519, United States
Yale-New Haven Hospital Spine Center
New Haven, Connecticut, 06878, United States
Holmes Regional Medical Center
Melbourne, Florida, 32901, United States
The B.A.C.K. Center
Melbourne, Florida, 32901, United States
Melbourne Regional Medical Center
Melbourne, Florida, 32935, United States
University of Miami Hospital and Clinics and Research Pharmacy
Miami, Florida, 33136, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Florida Hospital Orlando
Orlando, Florida, 32803, United States
Neuroscience ACS Research
Orlando, Florida, 32803, United States
Florida Hospital Orlando - Florida Hospital Investigational Drug Pharmacy
Orlando, Florida, 32804, United States
Gulfcoast Research Institute, LLC
Sarasota, Florida, 34232, United States
Emory University Clinic
Atlanta, Georgia, 30322, United States
Emory Orthopaedics & Spine Center
Atlanta, Georgia, 30329, United States
Emory Orthopaedics & Spine Hospital
Tucker, Georgia, 30084, United States
Bingham Memorial Hospital
Blackfoot, Idaho, 83221, United States
Bingham Memorial Specialty Clinic
Idaho Falls, Idaho, 83404, United States
Brent H. Greenwald, M.D. Neurological Surgery
Idaho Falls, Idaho, 83404, United States
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, 83404, United States
Mountain View Hospital
Idaho Falls, Idaho, 83404, United States
Snake River Research, PLLC
Idaho Falls, Idaho, 83404, United States
Physicians & Surgeons Clinic
Pocatello, Idaho, 83201, United States
Bingham Memorial Family Medicine & Specialty Clinic
Pocatello, Idaho, 83202, United States
University of Illinois Hospital and Health Sciences System - Hospital Pharmacy Services
Chicago, Illinois, 60612-4333, United States
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, 60612-7232, United States
Rush University Medical Center (RUMC) / Midwest Orthopedics at Rush University Medical Center (RUMC)
Chicago, Illinois, 60612, United States
Rush University Medical Center Pharmacy
Chicago, Illinois, 60612, United States
Rush University Medical Center Professional Office Building Infusion Pharmacy
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Hospital
Kansas City, Kansas, 66103, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Norton Healthcare Pharmacy
Louisville, Kentucky, 40202, United States
Norton Hospital
Louisville, Kentucky, 40202, United States
Norton Leatherman Spine Center
Louisville, Kentucky, 40202, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101-4643, United States
AAMC Research Pharmacy
Annapolis, Maryland, 21401, United States
Anne Arundel Health System Research Institute (AAHSRI)
Annapolis, Maryland, 21401, United States
Anne Arundel Medical Center Infusion Center
Annapolis, Maryland, 21401, United States
Anne Arundel Medical Center Laboratory
Annapolis, Maryland, 21401, United States
Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
Annapolis, Maryland, 21401, United States
University of Maryland Medical Systems, Department of Neurosurgery
Baltimore, Maryland, 21201, United States
University of Maryland Medical Systems, Investigational Drug Services
Baltimore, Maryland, 21201, United States
University of Maryland, Medical Systems, Oriole Park
Baltimore, Maryland, 21201, United States
John Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224, United States
Department of Orthopedic Surgery, The Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287, United States
John Hopkins Hospital
Baltimore, Maryland, 21287, United States
The Johns Hopkins Hospital Investigational Drug Service
Baltimore, Maryland, 21287, United States
Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
Bowie, Maryland, 20716, United States
Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
Odenton, Maryland, 21113, United States
Anne Arundel Medical Group Orthopedics and Sports Medicine Specialists
Pasadena, Maryland, 21122, United States
Massachusetts General Hospital, Clinical Research Pharmacy
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital Investigational Drug Services (IDS)
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
UMass Memorial Medical Center- Clinical Research Center
Worcester, Massachusetts, 01605, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605, United States
University of Massachusetts Medical Center Memorial Campus
Worcester, Massachusetts, 01605, United States
University of Michigan Investigational Pharmacy
Ann Arbor, Michigan, 48109-5008, United States
University Of Michigan Hospitals
Ann Arbor, Michigan, 48109-5338, United States
Detroit Receiving Hospital, Heart Hospital, Harper Hospital at
Detroit, Michigan, 48201, United States
Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Blodgett Hospital
Grand Rapids, Michigan, 49506, United States
Orthopaedic Associates of Michigan - Research
Grand Rapids, Michigan, 49525, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Bronson Spine and Scoliosis Specialists
Kalamazoo, Michigan, 49007, United States
Michigan Orthopaedic & Spine Surgeons
Rochester Hills, Michigan, 48307, United States
Beaumont Orthopaedic Center
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
Michigan Orthopaedic Institute
Southfield, Michigan, 48033, United States
Beaumont Health-Troy
Troy, Michigan, 48085, United States
Michigan Orthopaedic Institute
West Bloomfield, Michigan, 48322, United States
Twin Cities Spine Surgeons dba Twin Cities Spine Center
Minneapolis, Minnesota, 55404, United States
Allina Health - Abbott Northwestern Hospital /
Minneapolis, Minnesota, 55407, United States
Mayo Clinic Hospital, Methodist Campus
Rochester, Minnesota, 55902, United States
Mayo Clinic Rochester, Methodist Hospital Campus
Rochester, Minnesota, 55902, United States
Mayo Clinic Hospital, Methodist Campus
Rochester, Minnesota, 55905, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Center for Outpatient Health
St Louis, Missouri, 63108, United States
Barnes Jewish Center for Advanced Medicine
St Louis, Missouri, 63110, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Barnes Jewish Pharmacy
St Louis, Missouri, 63110, United States
Barnes-Jewish Pharmacy
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
The Rothman Institute Marlton, NJ Office
Marlton, New Jersey, 08053, United States
HackensackUMC Mountainside Hospital
Montclair, New Jersey, 07042, United States
Meridian Hospitals Corp c/o Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Ambulatory Care Center
Newark, New Jersey, 07103, United States
Cancer Center, Rutgers, The State University of New Jersey-New Jersey Medical School
Newark, New Jersey, 07103, United States
Doctors Office Center-Rutgers, The State University of New Jersey-New Jersey Medical School
Newark, New Jersey, 07103, United States
University Hospital - Pharmacy
Newark, New Jersey, 07103, United States
University Hospital
Newark, New Jersey, 07103, United States
The Rothman Institute Washington Township, NJ Office
Sewell, New Jersey, 08080, United States
Northwell Health Physician Partners- Department of Neurosurgery Spine @Great Neck
Great Neck, New York, 11021, United States
NYU Langone Huntington Medical Group
Huntington Station, New York, 11746, United States
UHS Neurosurgery
Johnson City, New York, 13790, United States
UHS Wilson Medical Center
Johnson City, New York, 13790, United States
Northwell Health Physician Partners- Department of Neurosurgery Spine @Lynbrook
Lynbrook, New York, 11563, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
The Feinstein Institute for Medical Research
Manhasset, New York, 11030, United States
NYU Langone Health Orthopedic Hospital
New York, New York, 10003, United States
Kimmel Pavillion
New York, New York, 10016, United States
NYU Langone Health Orthopedic Center
New York, New York, 10016, United States
NYU Langone Health Tisch Hospital
New York, New York, 10016, United States
NYU Langone Madison Ave. Orthopedics
New York, New York, 10016, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
lcahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
The Clinical Research Unit at Mount Sinai
New York, New York, 10029, United States
NYU Langone Seaport Orthopaedics
New York, New York, 10279, United States
Carolina Neurosurgery and Spine Associates, P.A.
Charlotte, North Carolina, 28204, United States
Novant Health Charlotte Orthopedic Hospital/Presbyterian Orthopedic Hospital
Charlotte, North Carolina, 28207, United States
OrthoCarolina Hip & Knee Center
Charlotte, North Carolina, 28207, United States
OrthoCarolina
Charlotte, North Carolina, 28207, United States
OrthoCarolina Pineville
Charlotte, North Carolina, 28210, United States
OrthoCarolina Ballantyne
Charlotte, North Carolina, 28277, United States
Duke University Hospital, IDS Pharmacy
Durham, North Carolina, 27710, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
OrthoCarolina Matthews
Matthews, North Carolina, 28105, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation - Investigation Pharmacy
Cleveland, Ohio, 44195, United States
Cleveland Clinic Foundation Center for Spine Health
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital Pharmacy
Columbus, Ohio, 43214, United States
Remington-Davis, Inc.
Columbus, Ohio, 43215, United States
Orthopedic One
Columbus, Ohio, 43220, United States
Dublin Methodist Hospital
Dublin, Ohio, 43016, United States
OHSU Research Pharmacy
Portland, Oregon, 97239, United States
Oregon Health and Sciences University
Portland, Oregon, 97239, United States
Abington Jefferson Health-Pharmacy Department
Abington, Pennsylvania, 19001, United States
Abington Jefferson Health
Abington, Pennsylvania, 19001, United States
Rothman Institute-Chalfont Office
Chalfont, Pennsylvania, 18914, United States
Milton S. Hershey Medical Center Pharmacy
Hershey, Pennsylvania, 17033, United States
Penn State College of Medicine and Penn State Hershey Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Investigational Drug Service Pharmacy
Philadelphia, Pennsylvania, 19107, United States
Jefferson Hospital For Neuroscience
Philadelphia, Pennsylvania, 19107, United States
The Rothman Institute
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital - Pre-Admission Testing Center
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital, Cardiovascular Associates
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Upmc (Puh/Muh)
Pittsburgh, Pennsylvania, 15213, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
Rothman Institute-Willow Grove Office
Willow Grove, Pennsylvania, 19090, United States
Dell Seton Medical Center at The University of Texas
Austin, Texas, 78701, United States
Austin Infectious Disease Consultants
Austin, Texas, 78705, United States
Employee Wellness Center
Austin, Texas, 78705, United States
Seton Medical Center Austin
Austin, Texas, 78705, United States
St. David's Medical Center
Austin, Texas, 78705, United States
St. David's Neuroscience and Spine Institute
Austin, Texas, 78705, United States
Seton Spine and Scoliosis Center
Austin, Texas, 78731, United States
St. David's North Austin Medical Center
Austin, Texas, 78758, United States
Wellness Brain and Spine
Austin, Texas, 78758, United States
Neurosurgical Specialist of Texas
Fredericksburg, Texas, 78624, United States
Hermann Drive Surgical Hospital
Houston, Texas, 77004, United States
Mermorial Hermann - Memorial City Medical Center
Houston, Texas, 77024, United States
Baylor College of Medicine - McNair Campus
Houston, Texas, 77030, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
CHI St. Luke's Health Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
Baylor Scott & White Medical Center
Plano, Texas, 75093, United States
Seton Brain and Spine Institute Williamson
Round Rock, Texas, 78665, United States
Seton Medical Center Williamson
Round Rock, Texas, 78665, United States
St. David's Round Rock Medical Center
Round Rock, Texas, 78681, United States
Scott & White Memorial Hospital and Clinic (Scott & White Roney Bone & Joint Institute)
Temple, Texas, 76508, United States
Scott & White Memorial Hospital and Clinic
Temple, Texas, 76508, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Clinical Alliance for Research and Education - Infectious Diseases, LLC (CARE-ID)
Annandale, Virginia, 22003, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Inova Medical Group
Fairfax, Virginia, 22031, United States
Inova Fair Oaks Hospital
Fairfax, Virginia, 22033, United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042, United States
Inova Neurosciences Research
Falls Church, Virginia, 22042, United States
OrthoVirginia
McLean, Virginia, 22102, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Sentara Medical Group DBA Sentara Neurosurgery Specialists
Norfolk, Virginia, 23510, United States
VCU Medical Center Investigational Drug Service
Richamond, Virginia, 23298-5028, United States
VCU Heatlh Neuroscience Orthopedic and Wellness Center
Richmond, Virginia, 23233, United States
VCU Health Ambulatory Care Center
Richmond, Virginia, 23298, United States
VCU Health
Richmond, Virginia, 23298, United States
Carilion Assessment, Registration and Education for Surgery (C.A.R.E.S)
Roanoke, Virginia, 24014, United States
Carilion Clinic - Department of Pharmacy
Roanoke, Virginia, 24014, United States
Carilion Clinic Institute for Orthopaedics and Neurosciences
Roanoke, Virginia, 24014, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014, United States
Carilion Clinic Riverside 3
Roanoke, Virginia, 24016, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
WVU Medicine Spine Center
Morgantown, West Virginia, 26505, United States
WVU Medicine JW Ruby Memorial Hospital
Morgantown, West Virginia, 26506-9196, United States
WVU Medicine JW Ruby Memorial Hospital In-Patient Pharmacy
Morgantown, West Virginia, 26506, United States
WVU Medicine Physician Office Center Orthopaedic Surgery
Morgantown, West Virginia, 26506, United States
WVU Medicine Physician Office Center
Morgantown, West Virginia, 26506, United States
Tirol Kliniken GmbH
Innsbruck, 6020, Austria
Tirol Kliniken
Innsbruck, 6020, Austria
MHAT "Sveta Marina" EAD
Varna, 9010, Bulgaria
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
Foothills Medical Centre, University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1M4, Canada
St, Michael's Hospital - St. Michael's Pharmacy
Toronto, Ontario, M5B 1W8, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Montreal Neurological Hospital Research Pharmacy
Montreal, Quebec, H3A 2B4, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
Montreal General Hospital Research Institute of the MUHC- MGH Pharmacy Research
Montreal, Quebec, H3G 1A4, Canada
CHU Pellegrin Tripode
Bordeaux, 33076, France
CHU Pellegrin, Pharmacie
Bordeaux, 33076, France
CHU de Dijon
Dijon, 21000, France
CHU de Dijon
Dijon, 21079, France
CHU Hopital d'Enfants
Dijon, 21079, France
AP-HM La Timone - Hopital adultes
Marseille, 13385, France
AP-HM Hopital Nord
Marseille, 13915, France
CHU de Nantes - Hotel Dieu
Nantes, 44093, France
CHU de Nimes - Caremeau
Nîmes, 30029, France
CHU de Nimes
Nîmes, 30029, France
CIC Cochin/Pasteur (CIC 1417)
Paris, 75014, France
Service de Chirurgie Orthopedique et Traumatologie
Paris, 75014, France
Service de Pharmacie
Paris, 75014, France
CHU de Rennes - Hopital Pontchaillou
Rennes, 35033, France
CHU de Rennes
Rennes, 35033, France
Unite d'investigation clinique
Rennes, 35033, France
Hopital Nord-CHU Saint Etienne
Saint-Priest-en-Jarez, 42270, France
Hopital Civil
Strasbourg, 67091, France
Hopitaux Universitaires de Strasbourg
Strasbourg, 67200, France
Charite- University Medicine Berlin
Berlin, 10117, Germany
Charite- University Medicine Berlin
Berlin, 13353, Germany
Uniklinik Koeln
Cologne, 50937, Germany
Klinikum rechts der Isar, Technische Universitat Munchen
München, 81675, Germany
Klinikum rechts der Isar
München, 81675, Germany
St. Franziskus Hospital Munster
Münster, 48415, Germany
Orszagos Gerincgyogyaszati Kozpont
Budapest, 1126, Hungary
Hakodate Central General Hospital
Hakodate, Hokkaido, 040-8585, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, 063-0005, Japan
Japan Organization of Occupational Health and Safety, Kanto Rosai Hospital
Kawasaki, Kanagawa, 211-8510, Japan
Nagasaki Rosai Hospital
Sasebo, Nagasaki, 857-0134, Japan
Saiseikai Kawaguchi General Hospital
Kawaguchi, Saitama, 332-8558, Japan
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558, Japan
National Hospital Organization Murayama Medical Center
Musashimurayama, Tokyo, 208-0011, Japan
Musashino Red Cross Hospital
Musashino, Tokyo, 180-8610, Japan
Shimonoseki City Hospital
Shimonoseki-shi, Yamaguchi, 750-8520, Japan
Japan Community Health care Organization Osaka Hospital
Osaka, 553-0003, Japan
Hospital Clínico Universitario Santiago de Compostela
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Fundacion Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Ramon Y Cajal
Madrid, 28034, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitario Politecnico La Fe
Valencia, 46026, Spain
Pharmacy Service of Hospital Clinico de Valladolid
Valladolid, 47003, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, 47005, Spain
GHP Stockholm Spine Center
Upplands Vasby, 19489, Sweden
Pharmacy Store, Main Pharmacy
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
Pharmacy Store
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
South Tees Hospitals NHS Foundation Trust
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
The James Cook University Hospital
Middlesbrough, Cleveland, TS4 3BW, United Kingdom
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD, United Kingdom
Centre for Spinal Studies and Surgery
Nottingham, NG7 2UH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
Related Publications (1)
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.
PMID: 37125490DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2015
First Posted
March 13, 2015
Study Start
July 2, 2015
Primary Completion
June 26, 2019
Study Completion
June 27, 2019
Last Updated
January 5, 2021
Results First Posted
September 2, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will share
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.