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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT03367559
Eligibility Criteria:
Inclusion Criteria:
* Healthy infants as established by medical history and clinical examination before entering the study.
* Age: 6-8 weeks
* Weight ≥ 2.5kg at birth.
* Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)
* Parental ability and willingness to provide informed consent.
* Parent who intends to remain in the area with the participant during the study period.
Exclusion Criteria:
* Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
* Presence of fever (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) on the day of enrollment (temporary exclusion).
* Concurrent participation in another clinical trial.
* Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant's health or is likely to result in non-conformance to the protocol.
* History of congenital abdominal disorders, intussusception, abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination.
* Prior receipt of rotavirus vaccine.
* A known sensitivity or allergy to any components of the study medication.
* Major congenital or genetic defect.
* Participant's parents not able, available or willing to accept active follow-up by the study staff.
* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
* History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
* History of any neurologic disorders or seizures.
* Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
8 Weeks
Study:
NCT03367559
Study Brief:
Protocol Section:
NCT03367559