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 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT02985320
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
* Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
* Proven legal identity;
* Participants (≥ 18 years old), or guardians of the participants (\< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
* Complying with the requirement of the study protocol;
* Axillary temperature ≤ 37.0 °C;
Exclusion Criteria:
* Breast feeding, pregnant, or expected to conceive in the next 60 days;
* History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
* Autoimmune disease or immunodeficiency/immunosuppressive;
* serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
* severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
* Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
* Long term history of alcoholism or drug abuse;
* Receipt of any of the following products:
1. Any subunit or inactivated vaccine within the past 7 day;
2. Any live attenuated vaccine within the past 14 days;
3. Any other investigational medicine(s) within the past 30 days;
4. Any blood product within the past 3 months;
5. Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
* Acute illness or acute exacerbation of chronic disease within the past 7 days;
* Axillary temperature \> 37.0 °C;
* Infant participants with prior vaccination of poliovirus;
* Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Months
Maximum Age:
49 Years
Study:
NCT02985320
Study Brief:
Protocol Section:
NCT02985320