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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT01056705
Eligibility Criteria:
Inclusion Criteria:
* Males and females, age from 60 days to 90 days;
* Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
* Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
* Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
* Axillary temperature ≤37℃.
Exclusion Criteria:
* Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
* Low platelet or bleeding disorder do not allow vaccination into the muscle;
* Have damaged or lower immunological function;
* Received blood, plasma or immunoglobulin treatment since birth;
* Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
* Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Exclusion Criteria for doses 2 and 3
* Have serious anaphylaxis or high fever, convulsion during first dose;
* Have any circus of Exclusion Criteria after Eligible for study;
* Have serious adverse event which related to previous vaccination; Withdrawal and Discontinuance Criteria;
* Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
* Vaccinated with any other vaccine（except DTP）;
* Stop observation determined by investigator owing to occurring serious adverse event;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Days
Maximum Age:
90 Days
Study:
NCT01056705
Study Brief:
Protocol Section:
NCT01056705