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 @ 2:33 AM
Ignite Modification Date:
2025-12-25 @ 2:33 AM
NCT ID:
NCT03581734
Eligibility Criteria:
Inclusion Criteria:
* Apparently healthy children aged 1 to 3 years of age. Family able to understand and comply with planned study procedures and consents to be in the study.
* Have received either no dose or only one dose of OPV ( 0 - 1 dose) and has not received any dose of IPV or OCV at any time before enrollment based upon immunization card record or history from parents.
Exclusion Criteria:
* Parents and children who are unable / unwilling to participate in the full length of the study for any reason.
* Child / family planning on moving away from the study area during the study period
* A diagnosis, suspicion of, or clinical condition consistent with an immunodeficiency disorder (either in the child or in a member of the immediate family) or is on long-term (\>3 months) of immunosuppressive therapy.
* A suspicion or known history of bleeding disorder that would contraindicate venipuncture.
* Acute diarrhea, infection or illness at the time of the first visit that would require the child's admission to a hospital or would contraindicate provision of OPV per country guidelines.
* History of severe allergic reaction to component of study vaccine
* Acute vomiting or diarrhea within 24 hours before the first visit.
* Severely malnourished children (Weight-for-age with z-score \< - 3 below the median of the WHO child growth standards.)
* Previously received 3 doses of OPV or single dose of IPV or OCV at any time before enrollment based upon immunization card record.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT03581734
Study Brief:
Protocol Section:
NCT03581734