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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT03722004
Eligibility Criteria:
Inclusion Criteria:
* Healthy infants 5 weeks of age (range: 35-41 days).
* Parents that consent for participation in the full length of the study.
* Parents that are able to understand and comply with planned study procedures.
Exclusion Criteria:
* Parents and infants who are 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 fIPV or collection of blood by venipuncture.
* Evidence of a chronic medical condition identified by a study medical officer during physical exam.
* Infection or illness at the enrolment visit (i.e., 5 weeks of age) that a study medical officer judges would prevent the start of study activities at 6 weeks of age (i.e., blood collection and vaccination).
* Receipt of any polio vaccine (OPV or IPV/fIPV) before enrolment based upon documentation or parental recall.
* Known allergy/sensitivity or reaction to polio vaccine, or its contents.
* Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through 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:
35 Days
Maximum Age:
41 Days
Study:
NCT03722004
Study Brief:
Protocol Section:
NCT03722004