The purpose of the study is to learn about how effective, safe, and tolerable the Clostridioides difficile (C. difficile) vaccine is in decreasing the number of C. difficile infections (pCDI) in adults 65 years of age or older.
The participants will receive either the C. difficile vaccine or placebo (saline). A placebo does not contain any active ingredients. The vaccines will be given as a shot into the upper arm muscle.
This study looks at the number of diarrhea (loose stools) events related to a C. difficile infection, so the length of the study can change. If these events happen quickly, the study may finish sooner; if they happen slowly, it could take longer. Sometimes, the study might stop early if the vaccine clearly works or clearly doesn't. Participants will stay in the study until enough events have occurred to answer the main question. On average, each person is expected to take part for up to about three and a half years.
During this time, participants will have 3 planned clinical visits and 3 planned phone visits. After these visits, more scheduled clinic visits will happen every year until the end of study.
Besides the scheduled study visits, if at any time during the study a participant has 3 or more loose stools in 24 hours, they will be asked to save the next one (the fourth or later) and contact the study site. The study site will check to see if it could be a C. difficile infection. This check may happen at the clinic or through a phone or video call.
Кой може да участва
Who Can Join the Study (Inclusion Criteria):
• People with recent or future planned contact with healthcare systems or who have recently received antibiotics.
Who Cannot Join the Study (Exclusion Criteria):
* Anyone who has had CDI before.
* Anyone who has had surgery to remove part of their small or large intestine.
* Anyone who often has diarrhea (meaning three or more loose stools in a day, more than once a month).
* Anyone who has already received a vaccine or special antibody treatment for C. difficile.
* Anyone who has had a serious allergic reaction to a vaccine or to any part of the study vaccines.
* Anyone who might not respond well to the vaccine because their immune system is weak (either from a disease or from treatment).
* Anyone with cancer that has spread, kidney failure, or another serious health problem.
Интервенции
C.difficile vaccine
BIOLOGICAL
Saline Placebo
OTHER
Места на провеждане
158
Argentina (8)
Fundación Huésped
Buenos Aires , Buenos Aires F.D.
Equipo Ciencia
Buenos Aires , Buenos Aires F.D.
Sanatorio Sagrado Corazón
Buenos Aires
Centro Medico Barrio Parque
Buenos Aires
Clinica Privada del Sol S.A
Córdoba , Córdoba Province
CDC Centro Médico
Lujan de Cuyo , Mendoza Province
NOT_YET_RECRUITING
Clinica Del Niño Y La Madre
Mar del Plata , Buenos Aires
Investigaciones Clínicas Salta (ICSAL)
Salta
NOT_YET_RECRUITING
Япония (1)
Tokyo-Eki Center-building Clinic
Chuo-ku , Tokyo
NOT_YET_RECRUITING
Великобритания (19)
Ormeau Clinical Trials
Belfast , Northern Ireland
Synexus Midlands Clinical Research Centre
Birmingham , WEST Midlands
NOT_YET_RECRUITING
Layton Medical Centre
Blackpool , Lancashire
Cheadle Community Hospital
Cheadle , Staffordshire
Lakeside Surgery
Corby , Northamptonshire
Royal Devon & Exeter Hospital
Exeter , Devon
Synexus Scotland Clinical Research Centre
Glasgow , Glasgow CITY
NOT_YET_RECRUITING
Panthera Biopartners - Glasgow
Glasgow
Manchester Royal Infirmary
Manchester
NOT_YET_RECRUITING
Synexus Manchester Clinical Research Centre
Manchester
Newquay Health Centre
Newquay , Cornwall
Knowle House Surgery
Plymouth , Devon
Panthera Biopartners - Preston
Preston , England
Panthera Biopartners - Manchester
Rochdale , Manchester
Panthera Biopartners - Sheffield
Sheffield
Southampton General Hospital
Southampton , Hampshire
Brunel Medical Practice (St Marychurch)
Torquay , Devon
NOT_YET_RECRUITING
North Wales Clinical Research Facility
Wrexham , Wrexham [wrecsam Gb-wrc]
NOT_YET_RECRUITING
Panthera Clinic - York
York , North Yorkshire
САЩ (130)
Albuquerque Clinical Trials, Inc.
Albuquerque , New Mexico
Accellacare - McFarland
Ames , Iowa
McFarland Clinic, PC
Ames , Iowa
North Alabama Research Center
Athens , Alabama
Emory Steiner Building Research Center
Atlanta , Georgia
NOT_YET_RECRUITING
Emory University Woodruff Extension Building (WEB)
Atlanta , Georgia
NOT_YET_RECRUITING
Johns Hopkins Bloomberg School of Public Health
Baltimore , Maryland
NOT_YET_RECRUITING
Ochsner Medical Complex - The Grove
Baton Rouge , Louisiana
NOT_YET_RECRUITING
Bay Pines VA Healthcare System
Bay Pines , Florida
NOT_YET_RECRUITING
NYU Langone Health
Brooklyn , New York
The University of Vermont Medical Center Inc.
Burlington , Vermont
NOT_YET_RECRUITING
UVM Larner College of Medicine MMG/VCT
Burlington , Vermont
NOT_YET_RECRUITING
Capital Area Research, LLC
Camp Hill , Pennsylvania
Accellacare - Cary
Cary , North Carolina
CTI Clinical Research Center
Cincinnati , Ohio
VA Northeast Ohio Healthcare System Louis Stokes Cleveland VA Medical Center
Cleveland , Ohio
Centricity Research Columbus Georgia Multispecialty
Columbus , Georgia
Family Health Watch - KeyPoint Clinical Research
Dallas , Texas
KeyPoint Clinical Research
Dallas , Texas
North Texas Infectious Diseases Consultants, P.A
Dallas , Texas
Kaiser Permanente Daly City
Daly City , California
The Hope Clinic of Emory University
Decatur , Georgia
Duke Vaccine and Trials Unit
Durham , North Carolina
Upstate Global Health Institute
East Syracuse , New York
Cedar Health Research - Euless
Euless , Texas
Providence Regional Medical Center Everett
Everett , Washington
NOT_YET_RECRUITING
Proactive Clinical Research,LLC
Fort Lauderdale , Florida
Velocity Clinical Research, Grand Island
Grand Island , Nebraska
Medication Management
Greensboro , North Carolina
Lakeview Clinical Research
Guntersville , Alabama
Hackensack Meridian Health Hackensack University Medical Center
Hackensack , New Jersey
HMH David Jurist Research Building
Hackensack , New Jersey
HMH Hackensack University Medical Center
Hackensack , New Jersey
Indago Research & Health Center, Inc
Hialeah , Florida
Accellacare - Hickory
Hickory , North Carolina
Atrium Health Wake Forest Baptist Infectious Disease-High Point
High Point , North Carolina
Memorial Hermann Hospital - TMC
Houston , Texas
NOT_YET_RECRUITING
The University of Texas Health Science Center at Houston
Houston , Texas
NOT_YET_RECRUITING
UT Physicians
Houston , Texas
NOT_YET_RECRUITING
DM Clinical Research- Cyfair
Houston , Texas
Mercury Clinical Research - Santa Clara Family Clinic
Houston , Texas
Medical Affiliated Research Center
Huntsville , Alabama
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville , Florida
Ochsner Clinic Foundation - Kenner Clinical Trials Unit
Kenner , Louisiana
NOT_YET_RECRUITING
New Phase Research and Development
Knoxville , Tennessee
Ochsner Lafayette General Medical Center
Lafayette , Louisiana
NOT_YET_RECRUITING
M3 Wake Research - Lake City
Lake City , Florida
Walker Family Care
Little River , South Carolina
Applied Research Center of Arkansas
Little Rock , Arkansas
Mount Sinai Queens
Long Island City , New York
Kaiser Permanente Los Angeles Medical Center
Los Angeles , California
Kaiser Permanente Oncology Pharmacy #014C
Los Angeles , California
North Shore University Hospital
Manhasset , New York
Northwell Health Infectious Disease
Manhasset , New York
Sacramento VA Medical Center
Mather , California
NOT_YET_RECRUITING
South Florida Research Organization
Medley , Florida
DM Clinical Research - Chicago
Melrose Park , Illinois
Clinical Neuroscience Solutions Inc.
Memphis , Tennessee
Care Research Inc
Miami , Florida
Entrust Clinical Research
Miami , Florida
Charisma Medical and Research Center
Miami Lakes , Florida
Palm Springs Community Health Center
Miami Lakes , Florida
NOT_YET_RECRUITING
NYU Langone Health
Mineola , New York
Northern Westchester Hospital
Mount Kisco , New York
Trial Management Associates, LLC
Myrtle Beach , South Carolina
Trial Management Associates
Myrtle Beach , South Carolina
The Vanderbilt Vaccine Research Program Clinic at The Village at Vanderbilt
Nashville , Tennessee
NOT_YET_RECRUITING
Vanderbilt Investigational Drug Service (IDS)
Nashville , Tennessee
NOT_YET_RECRUITING
Vanderbilt University Medical Center
Nashville , Tennessee
NOT_YET_RECRUITING
Vanderbilt Vaccine Research Program Laboratory
Nashville , Tennessee
NOT_YET_RECRUITING
Vanderbilt Vaccine Research Program
Nashville , Tennessee
NOT_YET_RECRUITING
Hackensack Meridian Jersey Shore University Medical Center
Neptune City , New Jersey
HOPE Tower at Jersey Shore University Medical Center
Neptune City , New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick , New Jersey
NOT_YET_RECRUITING
Columbia University Irving Medical Center
New York , New York
NOT_YET_RECRUITING
NYU Langone Health
New York , New York
Mount Sinai West
New York , New York
Mount Sinai Morningside
New York , New York
Icahn School of Medicine at Mount Sinai
New York , New York
AMR Clinical
Newton , Kansas
Kaiser Permanente Oakland
Oakland , California
NOT_YET_RECRUITING
University of Nebraska Medical Center
Omaha , Nebraska
NOT_YET_RECRUITING
Velocity Clinical Research, Omaha
Omaha , Nebraska
University Of Nebraska Medical Center
Omaha , Nebraska
NOT_YET_RECRUITING
Kaiser Permanente Ontario Medical Center
Ontario , California
Innovation Medical Research Center
Palmetto Bay , Florida
NOT_YET_RECRUITING
DM Clinical Research - Philadelphia
Philadelphia , Pennsylvania
Kaiser Permanente Center for Health Research
Portland , Oregon
Accellacare - Raleigh
Raleigh , North Carolina
Duke University Health System
Raleigh , North Carolina
Renown Center for Advanced Medicine
Reno , Nevada
Renown Regional Medical Center
Reno , Nevada
University Health
Reno , Nevada
Clinical Research Partners, LLC
Richmond , Virginia
NOT_YET_RECRUITING
Rochester Clinical Research, LLC
Rochester , New York
Kaiser Permanente Roseville
Roseville , California
Kaiser Permanente Sacramento
Sacramento , California
Kaiser Permanente South Sacramento
Sacramento , California
Accellacare - Salisbury
Salisbury , North Carolina
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City , Utah
Velocity Clinical Research, San Bernardino
San Bernardino , California
Kaiser Permanente - San Diego Medical Center
San Diego , California
Kaiser Permanente Viewridge Medical Office
San Diego , California
Kaiser Permanente San Jose
San Jose , California
Carbon Health - San Mateo - Hillsdale Mall
San Mateo , California
Kaiser Permanente Santa Clara
Santa Clara , California
Velocity Clinical Research, Savannah
Savannah , Georgia
Kaiser Permanente Washington Health Research Institute (KPWHRI)
Seattle , Washington
NOT_YET_RECRUITING
University of Washington - Harborview Medical Center
Seattle , Washington
Velocity Clinical Research, Sioux City
Sioux City , Iowa
Phelps Hospital Geriatric Medicine & Improvement Science
Sleepy Hollow , New York
South Jersey Infectious Disease
Somers Point , New Jersey
Revive Research Institute, Inc.
Southfield , Michigan
DM Clinical Research - Detroit
Southfield , Michigan
Velocity Clinical Research, Spartanburg
Spartanburg , South Carolina
Washington University School of Medicine
St Louis , Missouri
Sundance Clinical Research
St Louis , Missouri
Epic Medical Research-Sun City
Sun City , Arizona
Angels Clinical Research Institute
Tampa , Florida
Montefiore Medical Center
The Bronx , New York
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake , California
Dynamed Clinical Research, LP d/b/a DM Clinical Research
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