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RECRUITING Phase 3 ClinicalTrials.gov

A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07282665

Registry updated: 2026-10-13
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Description

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 does not work. 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 clinic 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.

Interventions

  • C.difficile vaccine (Biological)
    C.difficile vaccine given as an intramuscular injection
  • Saline Placebo (Other)
    0.9% sodium chloride solution given as a intramuscular injection

Eligibility criteria

Who Can Join the Study (Inclusion Criteria): • People with recent or future planned contact with healthcare systems, recent antibiotic exposure, or a diagnosis of certain chronic medical conditions. 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 or another serious health problem.

Conditions

Clostridoides Difficile Associated Disease

Locations

  • North Alabama Research Center — Athens, Alabama, United States
  • Lakeview Clinical Research — Guntersville, Alabama, United States
  • Medical Affiliated Research Center — Huntsville, Alabama, United States
  • Chinle Center for Indigenous Health — Chinle, Arizona, United States
  • Chinle Comprehensive Health Care Facility — Chinle, Arizona, United States
  • Epic Medical Research-Sun City — Sun City, Arizona, United States
  • Applied Research Center of Arkansas — Little Rock, Arkansas, United States
  • Kaiser Permanente Daly City — Daly City, California, United States
  • Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
  • Kaiser Permanente Oncology Pharmacy #014C — Los Angeles, California, United States
  • Sacramento VA Medical Center — Mather, California, United States
  • Kaiser Permanente Oakland — Oakland, California, United States
  • Kaiser Permanente Ontario Medical Center — Ontario, California, United States
  • Kaiser Permanente Roseville — Roseville, California, United States
  • Kaiser Permanente Sacramento — Sacramento, California, United States
  • Kaiser Permanente South Sacramento — Sacramento, California, United States
  • Velocity Clinical Research, San Bernardino — San Bernardino, California, United States
  • Kaiser Permanente - San Diego Medical Center — San Diego, California, United States
  • Kaiser Permanente Viewridge Medical Office — San Diego, California, United States
  • Kaiser Permanente San Jose — San Jose, California, United States
  • Carbon Health - San Mateo - Hillsdale Mall — San Mateo, California, United States
  • Kaiser Permanente Santa Clara — Santa Clara, California, United States
  • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc. — Toluca Lake, California, United States
  • Kaiser Permanente Walnut Creek — Walnut Creek, California, United States
  • Diablo Clinical Research, Inc. — Walnut Creek, California, United States
  • GW Vaccine Research Unit — Washington D.C., District of Columbia, United States
  • The GW Medical Faculty Associates — Washington D.C., District of Columbia, United States
  • Bay Pines VA Healthcare System — Bay Pines, Florida, United States
  • Proactive Clinical Research,LLC — Fort Lauderdale, Florida, United States
  • Clinical Neuroscience Solutions, LLC — Jacksonville, Florida, United States
  • M3 Wake Research - Lake City — Lake City, Florida, United States
  • South Florida Research Organization — Medley, Florida, United States
  • Care Research Inc — Miami, Florida, United States
  • Entrust Clinical Research — Miami, Florida, United States
  • Charisma Medical and Research Center — Miami Lakes, Florida, United States
  • Palm Springs Community Health Center — Miami Lakes, Florida, United States
  • Indago Research & Health Center, Inc — Miami Lakes, Florida, United States
  • Angels Clinical Research Institute — Tampa, Florida, United States
  • Emory Steiner Building Research Center — Atlanta, Georgia, United States
  • Emory University Woodruff Extension Building (WEB) — Atlanta, Georgia, United States
  • Centricity Research Columbus Georgia Multispecialty — Columbus, Georgia, United States
  • The Hope Clinic of Emory University — Decatur, Georgia, United States
  • Atlanta VA Medical Center — Decatur, Georgia, United States
  • Velocity Clinical Research, Savannah — Savannah, Georgia, United States
  • DM Clinical Research - Chicago — Melrose Park, Illinois, United States
  • Accellacare - McFarland — Ames, Iowa, United States
  • McFarland Clinic, PC — Ames, Iowa, United States
  • Velocity Clinical Research, Sioux City — Sioux City, Iowa, United States
  • AMR Clinical — Newton, Kansas, United States
  • Ochsner Medical Complex - The Grove — Baton Rouge, Louisiana, United States
  • Ochsner Clinic Foundation - Kenner Clinical Trials Unit — Kenner, Louisiana, United States
  • Ochsner Lafayette General Medical Center — Lafayette, Louisiana, United States
  • Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States
  • Johns Hopkins Bloomberg School of Public Health — Baltimore, Maryland, United States
  • VA Boston Healthcare System - West Roxbury — West Roxbury, Massachusetts, United States
  • Revive Research Institute, Inc. — Southfield, Michigan, United States
  • DM Clinical Research - Detroit — Southfield, Michigan, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Sundance Clinical Research — St Louis, Missouri, United States
  • Velocity Clinical Research, Grand Island — Grand Island, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Velocity Clinical Research, Omaha — Omaha, Nebraska, United States
  • University Of Nebraska Medical Center — Omaha, Nebraska, United States
  • Renown Center for Advanced Medicine — Reno, Nevada, United States
  • Renown Regional Medical Center — Reno, Nevada, United States
  • University Health — Reno, Nevada, United States
  • Hackensack Meridian Health Hackensack University Medical Center — Hackensack, New Jersey, United States
  • HMH David Jurist Research Building — Hackensack, New Jersey, United States
  • HMH Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Hackensack Meridian Health Jersey Shore University Medical Center — Neptune City, New Jersey, United States
  • HOPE Tower at Jersey Shore University Medical Center — Neptune City, New Jersey, United States
  • Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States
  • South Jersey Infectious Disease — Somers Point, New Jersey, United States
  • Albuquerque Clinical Trials, Inc. — Albuquerque, New Mexico, United States
  • Gallup Center for Indigenous Health — Gallup, New Mexico, United States
  • Gallup Indian Medical Center — Gallup, New Mexico, United States
  • Northern Navajo Medical Center — Shiprock, New Mexico, United States
  • Shiprock Center for Indigenous Health — Shiprock, New Mexico, United States
  • NYU Langone Health — Brooklyn, New York, United States
  • Upstate Global Health Institute — East Syracuse, New York, United States
  • Mount Sinai Queens — Long Island City, New York, United States
  • North Shore University Hospital — Manhasset, New York, United States
  • Northwell Health Infectious Disease — Manhasset, New York, United States
  • NYU Langone Health — Mineola, New York, United States
  • Northern Westchester Hospital — Mount Kisco, New York, United States
  • NYU Langone Health — New York, New York, United States
  • Mount Sinai West — New York, New York, United States
  • Mount Sinai Morningside — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai — New York, New York, United States
  • Columbia University Irving Medical Center — New York, New York, United States
  • Rochester Clinical Research, LLC — Rochester, New York, United States
  • Phelps Hospital Geriatric Medicine & Improvement Science — Sleepy Hollow, New York, United States
  • Staten Island University Hospital — Staten Island, New York, United States
  • Montefiore Medical Center — The Bronx, New York, United States
  • James J. Peters VA Medical Center — The Bronx, New York, United States
  • Accellacare - Cary — Cary, North Carolina, United States
  • Duke Vaccine and Trials Unit — Durham, North Carolina, United States
  • Medication Management — Greensboro, North Carolina, United States
  • Accellacare - Hickory — Hickory, North Carolina, United States
  • Atrium Health Wake Forest Baptist Infectious Disease-High Point — High Point, North Carolina, United States
  • Accellacare - Raleigh — Raleigh, North Carolina, United States
  • Duke University Health System-Duke Vaccine and Trials Unit Raleigh — Raleigh, North Carolina, United States
  • Duke University Health System — Raleigh, North Carolina, United States
  • Raleigh Medical Group P.A. — Raleigh, North Carolina, United States
  • Accellacare - Salisbury — Salisbury, North Carolina, United States
  • Accellacare - Wilmington — Wilmington, North Carolina, United States
  • Wilmington Health, PLLC — Wilmington, North Carolina, United States
  • Accellacare - Winston-Salem — Winston-Salem, North Carolina, United States
  • Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
  • CTI Clinical Research Center — Cincinnati, Ohio, United States
  • VA Northeast Ohio Healthcare System Louis Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States
  • Kaiser Permanente Center for Health Research — Portland, Oregon, United States
  • Capital Area Research, LLC — Camp Hill, Pennsylvania, United States
  • DM Clinical Research - Philadelphia — Philadelphia, Pennsylvania, United States
  • Walker Family Care — Little River, South Carolina, United States
  • Velocity Clinical Research, Spartanburg — Spartanburg, South Carolina, United States
  • New Phase Research and Development — Knoxville, Tennessee, United States
  • Clinical Neuroscience Solutions, LLC — Memphis, Tennessee, United States
  • The Vanderbilt Vaccine Research Program Clinic at The Village at Vanderbilt — Nashville, Tennessee, United States
  • Vanderbilt Investigational Drug Service (IDS) — Nashville, Tennessee, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Vanderbilt Vaccine Research Program Laboratory — Nashville, Tennessee, United States
  • Vanderbilt Vaccine Research Program — Nashville, Tennessee, United States
  • Family Health Watch - KeyPoint Clinical Research — Dallas, Texas, United States
  • KeyPoint Clinical Research — Dallas, Texas, United States
  • North Texas Infectious Diseases Consultants, P.A — Dallas, Texas, United States
  • Cedar Health Research - Euless — Euless, Texas, United States
  • Baylor College of Medicine — Houston, Texas, United States
  • Memorial Hermann Hospital - TMC — Houston, Texas, United States
  • The University of Texas Health Science Center at Houston — Houston, Texas, United States
  • UT Physicians — Houston, Texas, United States
  • DM Clinical Research- Cyfair — Houston, Texas, United States
  • Mercury Clinical Research - Santa Clara Family Clinic — Houston, Texas, United States
  • Dynamed Clinical Research, LP d/b/a DM Clinical Research — Tomball, Texas, United States
  • Northwest Houston Heart Center — Tomball, Texas, United States
  • J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States
  • The University of Vermont Medical Center Inc. — Burlington, Vermont, United States
  • UVM Larner College of Medicine MMG/VCT — Burlington, Vermont, United States
  • Clinical Research Partners, LLC — Richmond, Virginia, United States
  • Providence Regional Medical Center Everett — Everett, Washington, United States
  • Kaiser Permanente Washington Health Research Institute (KPWHRI) — Seattle, Washington, United States
  • University of Washington - Harborview Medical Center — Seattle, Washington, United States
  • Instituto Médico Platense (IMP) — La Plata, Buenos Aires, Argentina
  • Clinica Del Niño Y La Madre — Mar del Plata, Buenos Aires, Argentina
  • Fundación Huésped — Buenos Aires, Buenos Aires F.D., Argentina
  • Equipo Ciencia — Buenos Aires, Buenos Aires F.D., Argentina
  • Clinica Privada del Sol S.A — Córdoba, Córdoba Province, Argentina
  • CDC Centro Médico — Lujan de Cuyo, Mendoza Province, Argentina
  • Clinica Mayo de Urgencias Médicas Cruz Blanca S.R.L — San Miguel de Tucumán, Tucumán Province, Argentina
  • Hospital de Clinicas Presidente Nicolas Avellaneda — San Miguel de Tucumán, Tucumán Province, Argentina
  • Sanatorio Sagrado Corazón — Buenos Aires, Argentina
  • Centro Medico Barrio Parque — Buenos Aires, Argentina
  • Investigaciones Clínicas Salta (ICSAL) — Salta, Argentina
  • Kojunkai Daido Clinic — Nagoya, Aichi-ken, Japan
  • Kamiiida daiichi General Hospital — Nagoya, Aichi-ken, Japan
  • Aso Iizuka Hospital — Iizuka-shi, Fukuoka, Japan
  • Seishinkai Inoue Hospital — Itoshima, Fukuoka, Japan
  • Japan Community Healthcare Organization Kyushu Hospital — Kitakyushu-shi, Fukuoka, Japan
  • Fukuoka Shinmizumaki Hospital — Onga-gun, Fukuoka, Japan
  • Koga General Hospital — Koga, Ibaraki, Japan
  • Japanese Red Cross Kumamoto Hospital — Kumamoto, Kumamoto, Japan
  • National Hospital Organization Nagasaki Medical Center — Ōmura, Nagasaki, Japan
  • Nanbu Tokushukai Hospital — Shimajiri, Okinawa, Japan
  • Nozaki Tokushukai Hospital — Daitō, Osaka, Japan
  • Saga University Hospital — Saga, Saga-ken, Japan
  • Tokyo-Eki Center-building Clinic — Chuo-ku, Tokyo, Japan
  • National Center for Global Health and Medicine — Shinjuku, Tokyo, Japan
  • Newquay Health Centre — Newquay, Cornwall, United Kingdom
  • Royal Devon & Exeter Hospital — Exeter, Devon, United Kingdom
  • Knowle House Surgery — Plymouth, Devon, United Kingdom
  • Brunel Medical Practice (St Marychurch) — Torquay, Devon, United Kingdom
  • Panthera Biopartners - Preston — Preston, England, United Kingdom
  • Synexus Scotland Clinical Research Centre — Glasgow, Glasgow CITY, United Kingdom
  • Southampton General Hospital — Southampton, Hampshire, United Kingdom
  • Layton Medical Centre — Blackpool, Lancashire, United Kingdom
  • Panthera Biopartners - Manchester — Rochdale, Manchester, United Kingdom
  • Panthera Clinic - York — York, North Yorkshire, United Kingdom
  • Lakeside Surgery — Corby, Northamptonshire, United Kingdom
  • Ormeau Clinical Trials — Belfast, Northern Ireland, United Kingdom
  • Cheadle Community Hospital — Cheadle, Staffordshire, United Kingdom
  • North Wales Clinical Research Facility — Wrexham, Wrexham [wrecsam Gb-wrc], United Kingdom
  • Synexus Midlands Clinical Research Centre — Birmingham, United Kingdom
  • Panthera Biopartners - Glasgow — Glasgow, United Kingdom
  • Manchester Royal Infirmary — Manchester, United Kingdom
  • Synexus Manchester Clinical Research Centre — Manchester, United Kingdom
  • Panthera Biopartners - Sheffield — Sheffield, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record