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 @ 11:46 PM
Ignite Modification Date:
2025-12-24 @ 11:46 PM
NCT ID:
NCT01661751
Eligibility Criteria:
Inclusion Criteria:
* Healthy permanent residence 2 years of age and older, the subjects (or their guardians) are able to understand and sign the informed consent;
* Healthy male or female by oral history, physical examination and clinical judgment and who complies with vaccination of this product;
* Be able to comply with the requirements of clinical trial protocol and immunogenicity examination;
* Have no history of vaccination within the past 3 months and vaccination with other products within the last 2 weeks;
* Axillary temperature ≤37.0℃.
Exclusion Criteria:
* Any acute disease, such as: tumor, autoimmunity disease, progressive atherosclerotic disease or diabetes with complication, chronic obstructive pulmonary disease need oxygen uptake, acute or progressive hepatopathy or nephropathy, congestive heart-failure, etc.;
* Allergic to vaccines or drugs (history of allergy to any vaccine in the past);
* History of neurologic symptom or signs;
* Known or suspected (or high risk) impaired or abnormal immune function, e.g.: receive immunosuppressant or immunopotentiator therapy, take immunoglobulin or blood product or plasma extract (except the gastrointestinal tract) within the past 3 months, HIV infection or related disease, etc.;
* History of meningitis infection or vaccination of meningococcal vaccine within the past 3 months;
* History of receiving other vaccines or immunoglobulin injection or any research drugs;
* Any acute disease needing application of antibiotics or anti-virus treatment in the whole body within the past 1 week;
* History of fever within the past 3 days (axillary temperature ≥38.0℃);
* Participating in another clinical trial;
* History of allergy, eclampsia, epilepsy, encephalopathy and mental disease or family disease;
* Thrombopenia or other coagulopathy that may cause contraindication to intramuscular injection;
* Acute chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease, Guillain-Barre Syndrome);
* Known or suspected diseases, including: respiratory system disease, acute infection or active stage of chronic disease, SBAV infection of children or mothers, cardiovascular disease, acute hypertension, cancer treatment, skin disease, etc.;
* Pregnancy
* Any condition that, in the judgment of investigator, may affect trial assessment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT01661751
Study Brief:
Protocol Section:
NCT01661751