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 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT03801161
Eligibility Criteria:
Inclusion criteria:
1. 9 - 18 months of age
2. Infants with normal body temperature and normal CRP (\<5 mg/L)
3. Infants receive breast milk from the mother at least once per day
4. Mothers produce a breast milk containing 30-40 nmol vitamin A /g milk fat
5. Infants received a high-dose vitamin A capsules at the time of the most recent national distribution campaign (within the last 2-4 months)
6. Mother is 18 - 45 years of age
7. Mother and her infant plan to stay in the study area for the duration of the study
Exclusion criteria:
1. Mother or infant has chronic disease
2. Mother or infant has acute illness on the day of data collection
3. Infant is anemic (Hb \<90 g/L)
4. Infant has weight for length \<80% of the reference median
5. Infants do not develop inflammation (CRP ≥5 mg/L) after PENTA vaccination
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
9 Months
Maximum Age:
18 Months
Study:
NCT03801161
Study Brief:
Protocol Section:
NCT03801161