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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT01508533
Eligibility Criteria:
Inclusion Criteria:
* Parents/guardian consent for participation and are able to understand study procedures
* Healthy infant aged ≤ 1 week - cohort I, children aged 12 months (+14 days)-Cohort 2
* Absence of any illness requiring hospitalization
* No confirmed plans to move in the next 12 months
Exclusion Criteria:
* Participating in any other trial
* Any signs or symptoms of active sepsis, pneumonia, meningitis or any other disease requiring hospitalization
* Known case of immunodeficiency disease, known HIV positive
* Known case of chronic gastrointestinal disease
* Any other conditions which in the judgment of the investigator warrant exclusion(e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
24 Months
Study:
NCT01508533
Study Brief:
Protocol Section:
NCT01508533