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 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT00953056
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults ages 19 to 47 years for Cohort I
* Healthy children ages 2 to 6 years for Cohort II
* Healthy infants ages 6 to 12 weeks for Cohort III
* Negative pregnancy test for females in Cohort I
* Signed Informed Consent Forms (ICFs)
Exclusion Criteria:
* Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
* Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
* Prior administration of any rotavirus vaccine
* Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
* Prior or active gastrointestinal illnesses, immunodeficiency
* Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
47 Years
Study:
NCT00953056
Study Brief:
Protocol Section:
NCT00953056