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

C.diff Vaccine in Adults 65 Years of Age and Older

Short Title: A Study to Learn About a Clostridioides difficile Vaccine in People 65 Years of Age and Older

Enrollment Status: Recruiting

NCT #: NCT07282665

Specialty Area: Infectious Disease

Condition Studied: C.difficile Infection

Age Group: Older Adult

Phase: III

Study Information

Summary / Purpose

To evaluate the efficacy, safety, and tolerability of Clostridioides (formerly Clostridium) difficile (C. difficile) adjuvanted vaccine in reducing the incidence of primary C. difficile infection (pCDI) in adults ≥65 years of age

Study Type: Interventional

Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:

Adults 65+ years of age
Increased risk of future development of Clostridoides difficile infection
No prior episode of C. difficile infection, small- or large bowel resection, metastatic malignancy, or end-state renal disease

What's Involved

Participation in the study will include:

Random assignment to receive the study medication or placebo given as 2 injections
Blood and stool samples
A study electronic diary
Questionnaires

Principal Investigator

Samuel Lee MD, Ph.D.

Infectious Diseases

(775) 982–3866

Renown Infectious Disease

View Provider

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Complete Study Details: https://clinicaltrials.gov/study/NCT07282665

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

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