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 @ 1:43 PM
Ignite Modification Date:
2025-12-24 @ 1:43 PM
NCT ID:
NCT02561195
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female subjects
* Aged 65 to 85 years
Additional Inclusion Criteria for the extension Stage:
* Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.
Exclusion Criteria:
* Proven or suspected prior episode of Clostridium difficile associated diarrhea
* Unstable chronic medical condition
* Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
* Serious chronic disorders
* Congenital or acquired immunodeficiency disorders
* Rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications.
* Active or treated leukemia or lymphoma or bone marrow disorder
* Any contraindication to vaccination or vaccine components including previous anaphylactic reaction to any vaccine or vaccine-related components
Additional Exclusion Criteria for the Extension Stage:
* Subjects originally randomized to placebo during the original portion of the study.
* Subjects who have already completed Visit 9 prior to study unblinding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT02561195
Study Brief:
Protocol Section:
NCT02561195