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 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT01813604
Eligibility Criteria:
Inclusion Criteria:
* Healthy infants 6-7 weeks of age
* Family that consents for participation in the full length of the study
* Family that is able to understand and comply with planned study procedures
Exclusion Criteria:
* Family that is unable to participate in the full length of the study
* A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member
* A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture
* Acute diarrhea, infection or illness at the time of enrollment (6-7 weeks of age) that would require infant's admission to a hospital or would contraindicate provision of OPV per country guidelines
* Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age)
* Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall
* Known allergy/sensitivity or reaction to polio vaccine or contents of polio vaccine
* Infants from multiple births. Infants from multiple are excluded to reduce the potential for contact transmission of vaccine poliovirus. The infant from a multiple birth who is not enrolled is likely to receive routine immunization and transmit vaccine poliovirus to the enrolled infant
* Infants from premature births (\<37 weeks of gestation)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Weeks
Maximum Age:
7 Weeks
Study:
NCT01813604
Study Brief:
Protocol Section:
NCT01813604