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RECRUITING

NCT07282665

PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

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.

Official title: A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF A CLOSTRIDIOIDES DIFFICILE VACCINE IN ADULTS 65 YEARS OF AGE AND OLDER

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32000

Start Date

2025-12-10

Completion Date

2029-06-07

Last Updated

2026-02-27

Healthy Volunteers

Yes

Conditions

Clostridioides Difficile Associated Disease

Interventions

BIOLOGICAL

C.difficile vaccine

C.difficile vaccine given as an intramuscular injection

OTHER

Saline Placebo

0.9% sodium chloride solution given as a intramuscular injection

Locations (129)

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

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

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

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

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

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

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

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

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

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