A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Purpose
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.
Condition
- Clostridioides Difficile Associated Disease
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental C.difficile vaccine |
Novel vaccine formulation |
|
|
Other Saline Placebo |
|
Recruiting Locations
Athens, Alabama 35611
Guntersville, Alabama 35976
Huntsville, Alabama 35801
Sun City, Arizona 85351
Little Rock, Arkansas 72205
San Bernardino, California 92408
San Mateo, California 94403
Toluca Lake, California 91602
Walnut Creek, California 94598
Fort Lauderdale, Florida 33308
Hialeah, Florida 33012
Jacksonville, Florida 32256
Lake City, Florida 32055
Medley, Florida 33166
Miami, Florida 33130
Miami, Florida 33176
Miami Lakes, Florida 33014
Tampa, Florida 33614
Columbus, Georgia 31904
Decatur, Georgia 30030
Savannah, Georgia 31406
Melrose Park, Illinois 60160
Ames, Iowa 50010
Ames, Iowa 50010
Sioux City, Iowa 51106
Newton, Kansas 67114
Southfield, Michigan 48075
Southfield, Michigan 48076
St Louis, Missouri 63141
Grand Island, Nebraska 68803
Reno, Nevada 89502
Reno, Nevada 89502
Reno, Nevada 89519
Somers Point, New Jersey 08244
Albuquerque, New Mexico 87102
East Syracuse, New York 13057
Rochester, New York 14609
Cary, North Carolina 27518
Hickory, North Carolina 28601
Raleigh, North Carolina 27609
Salisbury, North Carolina 28144
Wilmington, North Carolina 28401
Cincinnati, Ohio 45212
Portland, Oregon 97227
Camp Hill, Pennsylvania 17011
Philadelphia, Pennsylvania 19107
Little River, South Carolina 29566
Myrtle Beach, South Carolina 29572
Myrtle Beach, South Carolina 29572
Knoxville, Tennessee 37909
Memphis, Tennessee 38119
Dallas, Texas 75237
Dallas, Texas 75240
Houston, Texas 77065
Houston, Texas 77087
Tomball, Texas 77375
Tomball, Texas 77375
Salt Lake City, Utah 84121
Seattle, Washington 98104
More Details
- Status
- Recruiting
- Sponsor
- Pfizer