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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT01949857
Eligibility Criteria:
Inclusion Criteria:
* Only subjects fulfilling all of the following criteria will be eligible for the study:
* People aged from 18 months to 65 years old.
* The subjects or subjects' guardians are able to understand and sign the informed consent
* The subjects or subjects' guardians allow to comply with the requirements of the protocol
* Subjects with temperature \<=37.0°C on axillary setting
* The subjects have signed informed consent already
Exclusion Criteria:
* Subjects will not be eligible for the study if any of the following criteria is met:
* Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
* Have a history of neurological symptoms or signs
* Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
* Suffering from serious chronic diseases
* Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
* Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
* Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
* Any prior diseases including human immunodeficiency virus infection or related
* Bleeding constitution or prolong bleeding time situation
* Accept hepatitis A vaccination within a month
* Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
* People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
* Caught a fever with axillary temperature 38°C or higher in past 3 days
* Take part in another clinical researchers
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
* Pregnancy test result is positive
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Months
Maximum Age:
65 Years
Study:
NCT01949857
Study Brief:
Protocol Section:
NCT01949857