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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT03025750
Eligibility Criteria:
Inclusion Criteria:
* Infants 2 months of age (54-75 days of age) on date of first vaccination
* Healthy assessed from medical history and physical examination
* Parent(s)/guardian(s) have been properly informed about the trial and signed informed consent form
* Parent(s)/guardian(s)granted access to the infant's trial related medical records
* Parent(s)/guardian(s)are likely to comply with trial procedures
Exclusion Criteria:
* Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
* 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 trial
* Low birth weight (\< 2,500 g)
* Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
* Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
* Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
* Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
* Treatment with a product which is likely to modify the immune response (e.g. systemic corticosteroids, blood products and immunoglobulins) prior to inclusion or planned during the trial period
* Participating in another clinical trial
* Not suitable for inclusion in the opinion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
54 Days
Maximum Age:
75 Days
Study:
NCT03025750
Study Brief:
Protocol Section:
NCT03025750