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:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT01278433
Eligibility Criteria:
Inclusion Criteria:
* Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
* Subject's parent /legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio according to the schedule. one injection at 2, 3, 4 months old respectively;
* Informed consent form obtained by the subject's parent/legal representative.
* Subject plan to live in the selected study sites for at least three months after inclusion.
Exclusion Criteria:
* Subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
* Acute medical illness with or without fever within the last 72 hours.
* Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
* Participation in another clinical trial at the same time.
* Contraindications to vaccination according to IMOVAX Polio™ leaflet.
* Subject plan to leave the study sites for at least three months after inclusion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Days
Maximum Age:
89 Days
Study:
NCT01278433
Study Brief:
Protocol Section:
NCT01278433