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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT04448132
Eligibility Criteria:
Inclusion Criteria:
1. Children that have been vaccinated with IPV-Al AJV in the VIPV-07 and VIPV-07 E1 trials and have completed these trials
2. Healthy, as assessed from medical history and physical examination
3. Parent(s)/guardian(s), according to the local legal requirements, have been properly informed about the trial and have signed the informed consent form
4. Parent(s)/guardian(s), according to the local legal requirements, have been granted access to the child´s trial related medical records
5. Parent(s)/guardian(s), according to the local legal requirements, are likely to comply with trial procedures
Exclusion Criteria:
1. Previous vaccination with OPV
2. Previous vaccination with IPV outside the VIPV-07 and VIPV-07 E1 trials
3. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV is not an exclusion criterion.
4. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
5. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde and/or 2-phenoxy-ethanol)
6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
7. Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial period
8. Participating in another interventional clinical trial
9. Not suitable for inclusion in the opinion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
4 Years
Study:
NCT04448132
Study Brief:
Protocol Section:
NCT04448132