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 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT04700618
Eligibility Criteria:
Inclusion Criteria:
1. The age was 60-70 years old on the day of enrollment;
2. The subjects have signed the informed consent and signed the date;
3. The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);
4. The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
5. The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.
Exclusion Criteria:
1. With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
2. Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.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);
4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
70 Years
Study:
NCT04700618
Study Brief:
Protocol Section:
NCT04700618