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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT00439660
Eligibility Criteria:
Inclusion Criteria:
1. Access to telephone at home or in the immediate neighborhood.
2. Healthy male and female non-malnourished (weight for length not ≤ -3 SD of WHO child growth standards) infants aged 6 weeks (till 6 weeks + 2 days).
3. Parent's permission to participate in the study is available.
4. No plans to travel over the next 4 months
Exclusion Criteria:
1. Gestational age \<37 weeks.
2. Any major physical congenital malformation.
3. Living in a household or has contact with an individual who is immunosuppressed.
4. Hospitalized once or more for the following illnesses since birth: heart disease, pneumonia, sepsis, meningitis, unconsciousness.
5. Is required to take daily medications other than vitamins or herbal "tonics".
6. Evidence of cardiovascular disease as indicated by any of the following:
* Central cyanosis
* Cyanotic or apnoeic spells
* Features of congestive heart failure
* Significant heart murmur detected on physical examination
7. Evidence of gastrointestinal disease indicated by following:
* Diarrhea in the previous 7 days
* Blood in the stools any time since birth
8. Evidence of neurological disease, as indicated by:
* History of seizures any time since birth
* History of unconsciousness
* Focal deficit on physical examination
9. Evidence of liver or other reticuloendothelial disease, as indicated by any of the following:
* Positive serology for hepatitis B surface antigen
* Positive serology for hepatitis C antibody
* SGOT or SGPT more than 1.25 times upper limit of normal (Upper limit normal SGOT 80 IU/L, SGPT 40 IU/L)
* Alkaline phosphatase more than 1.25 times upper limit of normal (Upper limit of normal -470 IU/L)
* Hepatomegaly (liver palpable 3 cm below costal margin), splenomegaly (palpable spleen), jaundice, or lymphadenopathy on physical examination
* Serum bilirubin 1.25 times the upper limit of normal for age (Upper limit of normal 1.0 mg/dL).
10. Evidence of hematologic, rheumatologic, or immunologic disease, as indicated by any of the following:
* Total leukocyte count \<3500 or \>15,000/mm3
* Hemoglobin \<9 g/dL or \>17g/dL
* Platelet count \<100,000/mm3
* Any episode of sepsis, pneumonia or meningitis requiring hospitalization since birth.
11. Evidence of renal disease as indicated by any of the following:
* Creatinine \>0.5 mg/dL
* Hematuria (≥5 RBC/hpf)
* Proteinuria (≥1+ per day)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Weeks
Maximum Age:
20 Weeks
Study:
NCT00439660
Study Brief:
Protocol Section:
NCT00439660