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 @ 2:55 AM
Ignite Modification Date:
2025-12-25 @ 2:55 AM
NCT ID:
NCT01886833
Eligibility Criteria:
Inclusion Criteria:
* Mother willing to participate voluntarily and able to provide signed informed consent (with witness in the case of illiterate participant)
* Infant eligible for rotavirus vaccine immunization as per national policy (male or female infant, 6-12 weeks old)
* Mother willing to undergo study procedures, including questionnaires, HIV counselling and testing, CD4 testing, and provide breast milk and blood sample at enrolment.
* Mother willing for child to undergo study procedures including full-course rotavirus vaccination, phlebotomy at enrolment and 1 month post-rotavirus vaccination, and presentation to clinic for collection of stool sample when infant has diarrhoea.
* Plans to remain resident in the area and willing to come for scheduled visits for the duration of the study.
Exclusion Criteria:
* Contraindication to rotavirus vaccination.
* Previous administration of rotavirus vaccine to child.
* Recent immunosuppressive therapy in child (including high-dose systemic corticosteroids).
* History of ever receiving a blood transfusion or blood products, including immunoglobulins within the last 6 months, for mother and child.
* Mother plans for herself or child to move away from the study catchment area within the next two years.
* Any condition deemed by the study investigator to pose potential harm to the participants or jeopardize the validity of study results.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
15 Weeks
Study:
NCT01886833
Study Brief:
Protocol Section:
NCT01886833