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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT04559204
Eligibility Criteria:
Inclusion Criteria:
* subjects aged no younger than 3 years old on the day of recruitment;
* with valid informed consent signed by parent(s) or guardian(s);
* parent(s) or guardian(s) are able to attend all scheduled appointments and comply with all study instructions;
* subjects have not received any seasonal influenza vaccine or pneumonia vaccine before;
* axillary temperature ≤37.0℃
Exclusion Criteria:
* subject who has a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia or neurological illness;
* allergic to any ingredient of vaccine or with allergy history to any vaccine;
* subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(taking orally injecting of steroid hormone);
* administration of immunoglobulins within 30 days prior to this study;
* acute febrile disease(temperature ≥ 37.0°C) or infectious disease;
* have a clearly diagnosed history of thrombocytopenia or other coagulopathy, which might cause contraindications for subcutaneous injection;
* any serious chronic illness, acute infectious diseases, or respiratory diseases; severe cardiovascular disease, liver and kidney diseases or diabetes mellitus with complications;
* any kind of infectious, purulent, or allergic skin diseases;
* pregnant women and breastfeeding women;
* inoculated with any vaccine within 14 days of the study;
* any other factor that makes the investigator determines the subject is unsuitable for this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT04559204
Study Brief:
Protocol Section:
NCT04559204