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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT05677256
Eligibility Criteria:
Inclusion Criteria:
1. Infants aged 6 to 8 weeks with birth weight \>2,500 g.
2. Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of corticosteroids or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
3. Written informed consent obtained from both parents or legal guardian(s) as per country regulations.
Exclusion Criteria:
1. Infants who have received previous vaccination against poliomyelitis.
2. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus infection in the potential participant or any member of the subject's household.
3. Family history of congenital or hereditary immunodeficiency.
4. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
5. Known allergy to any component of the study vaccines or to any antibiotics that share molecular composition with a component of the study vaccines.
6. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections (of IPV)
7. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
8. Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a contraindication for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
9. Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
10. Infants from multiple births or born prematurely (\< 37 weeks of gestation).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Weeks
Maximum Age:
8 Weeks
Study:
NCT05677256
Study Brief:
Protocol Section:
NCT05677256