A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
NCT ID: NCT07282665
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
32000 participants
INTERVENTIONAL
2025-12-10
2029-06-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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C.difficile vaccine
Novel vaccine formulation
C.difficile vaccine
C.difficile vaccine given as an intramuscular injection
Saline Placebo
Saline Placebo
0.9% sodium chloride solution given as a intramuscular injection
Interventions
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C.difficile vaccine
C.difficile vaccine given as an intramuscular injection
Saline Placebo
0.9% sodium chloride solution given as a intramuscular injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
65 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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North Alabama Research Center
Athens, Alabama, United States
Lakeview Clinical Research
Guntersville, Alabama, United States
Medical Affiliated Research Center
Huntsville, Alabama, United States
Epic Medical Research-Sun City
Sun City, Arizona, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Velocity Clinical Research, San Bernardino
San Bernardino, California, United States
Carbon Health - San Mateo - Hillsdale Mall
San Mateo, California, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, 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
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
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
Innovation Medical Research Center
Palmetto Bay, Florida, United States
Angels Clinical Research Institute
Tampa, Florida, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, 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
Revive Research Institute, Inc.
Southfield, Michigan, United States
DM Clinical Research - Detroit
Southfield, Michigan, United States
Sundance Clinical Research
St Louis, Missouri, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Velocity Clinical Research, Omaha
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
South Jersey Infectious Disease
Somers Point, New Jersey, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, United States
Upstate Global Health Institute
East Syracuse, New York, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Accellacare - Cary
Cary, North Carolina, United States
Medication Management
Greensboro, North Carolina, United States
Accellacare - Hickory
Hickory, North Carolina, United States
Accellacare - Raleigh
Raleigh, North Carolina, United States
Accellacare - Salisbury
Salisbury, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, United States
CTI Clinical Research Center
Cincinnati, 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
Trial Management Associates, LLC
Myrtle Beach, South Carolina, United States
Trial Management Associates
Myrtle Beach, 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 Inc.
Memphis, Tennessee, United States
Family Health Watch - KeyPoint Clinical Research
Dallas, Texas, United States
KeyPoint Clinical Research
Dallas, Texas, United States
Cedar Health Research - Euless
Euless, 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
Clinical Research Partners, LLC
Richmond, Virginia, United States
University of Washington - Harborview Medical Center
Seattle, Washington, United States
Equipo Ciencia
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Sagrado Corazón
Buenos Aires, , Argentina
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
Panthera Biopartners - Manchester
Rochdale, Manchester, United Kingdom
Panthera Clinic - York
York, North Yorkshire, United Kingdom
Lakeside Surgery
Corby, Northamptonshire, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, Scotland, United Kingdom
Synexus Midlands Clinical Research Centre
Birmingham, , United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, , United Kingdom
Panthera Biopartners - Sheffield
Sheffield, , United Kingdom
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4771002
Identifier Type: -
Identifier Source: org_study_id
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