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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT02839161
Eligibility Criteria:
Inclusion Criteria:
1. Males or females between 6 and 10 years, inclusive, who are long-term residents of the study area.
2. Good general health as determined by means of the screening procedure.
3. Assumed availability for the duration of the trial (up to 15 months).
4. Willingness of parent or legal guardian for child to participate in the study as evidenced by signing the informed consent document in combination with the child assent form.
5. Negative for hookworm during screening, or if found to be infected with hookworm, has completed a course of three doses of albendazole.
Exclusion Criteria:
1. Inability of parent/legal guardian to correctly answer all questions on the informed consent comprehension questionnaire.
2. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
3. Known or suspected immunodeficiency.
4. Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
5. Laboratory evidence of renal disease (serum creatinine greater than 1.25-times the upper reference limit, or more than 1+ protein, or more than trace blood on urine dipstick testing with the exception of greater than trace blood detected in females during menses).
6. Laboratory evidence of hematologic disease (absolute leukocyte count \<4500/mm3; absolute leukocyte count \>13.0 x 103/mm3; hemoglobin \<9.5 g/dl; or, platelet count \<140,000/mm3).
7. Other condition that in the opinion of the investigator could jeopardize the safety or rights of a child participating in the trial or would render the child unable to comply with the protocol.
8. Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study.
9. History of a severe allergic reaction or anaphylaxis.
10. Severe asthma as defined by the need for daily use of inhalers or emergency room/clinic visit or hospitalization within 6 months of the child's planned first vaccination in the study.
11. Positive for HCV.
12. Positive for HBsAg.
13. Positive for HIV infection.
14. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or expect to use for the duration of the study.
15. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
16. History of a surgical splenectomy.
17. Receipt of blood products within the 6 months prior to entry into the study.
18. Previous receipt of a primary series (three doses according to a 0, 1, and 6 -12 month schedule) of the hepatitis B vaccine.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
10 Years
Study:
NCT02839161
Study Brief:
Protocol Section:
NCT02839161