Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT00127803
Eligibility Criteria:
Inclusion Criteria:
* Adult males or females, 18-55 years (inclusive)
* In good general health
* Clinical lab tests within normal range
* Non-pregnant female subjects
* Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine
Exclusion Criteria:
* Evidence of C. difficile infection
* Evidence of any previous antibiotic-associated diarrhea
* Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
* History of malignancy within 5 years
* History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
* Known or suspected history of immunodeficiency;
* Active or inactive immune-mediated or inflammatory disease;
* Pregnant or lactating female subjects;
* History of drug or alcohol abuse disorders;
* Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* Receipt of antibiotic therapy or an investigational drug within prior 30 days
* Blood or organ donation within prior 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00127803
Study Brief:
Protocol Section:
NCT00127803