AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males or females between 6 and 10 years, inclusive, who are long-term residents of the study area.
✓. Good general health as determined by means of the screening procedure.
✓. Assumed availability for the duration of the trial (up to 15 months).
✓. 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.
✓. Negative for hookworm during screening, or if found to be infected with hookworm, has completed a course of three doses of albendazole.
Exclusion criteria
✕. Inability of parent/legal guardian to correctly answer all questions on the informed consent comprehension questionnaire.
✕. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, diabetes, or renal disease by history, physical examination, and/or laboratory studies.
✕. Known or suspected immunodeficiency.
✕. Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25-times the upper reference limit).
✕. 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).
✕. 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.
✕. Participation in another investigational vaccine or drug trial within 30 days of starting this study or for the duration of the study.