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 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT05163561
Eligibility Criteria:
Inclusion Criteria:
1. Healthy infants as established by medical history and clinical examination before entering the study
2. Age: 6-8 weeks at the time of enrolment
3. Parental ability and willingness to provide informed consent
4. Parent who intends to reside in the area with the infant during the study period
Exclusion Criteria:
1. Presence of fever on the day of enrolment \[Temporary exclusion criteria\].
2. Acute disease at the time of enrolment \[Temporary exclusion criteria\].
3. Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period.
4. OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3-months prior to inclusion or planned during the study.
5. Presence of significant malnutrition (weight-for-height z-score \< -3SD median)
6. Known or suspected impairment of immunological function based on medical history and physical examination.
7. Presence of 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 participant's health or is likely to result in nonconformance to the protocol.
8. A known sensitivity or allergy to any components of the Investigational Product.
9. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period
10. Planned concurrent participation in another clinical study at any point throughout the entire study period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
8 Weeks
Study:
NCT05163561
Study Brief:
Protocol Section:
NCT05163561