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Clinical Trials/jRCT2031260066
jRCT2031260066
Recruiting
Not Applicable

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 (BEETHOVEN)

Not provided0 sites32,000 target enrollmentStarted: TBD

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
32,000

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Randomized

Eligibility Criteria

Ages
65age old over to No limit (—)
Sex
All

Inclusion Criteria

  • Who Can Join the Study (Inclusion Criteria):
  • People with recent or future planned contact with healthcare systems or who have recently received antibiotics.

Exclusion Criteria

  • 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.

Investigators

Sponsor
Not provided

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