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 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT02451969
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteer ≥ 2 years old;
* Proven legal identity;
* Written consent of the guardian of participants \< 18 years old, and written consent of the participant ≥ 12 years old;
* Complying with the requirement of the study protocol;
Exclusion Criteria:
* Prior vaccination with pneumococcal vaccine;
* History of bacterial pneumonia within 3 years prior to this study;
* Pregnant, breast feeding, or women expected to conceive within 60 days after vaccination;
* History of allergy to any vaccine or vaccine ingredient;
* Receipt of any of the following products:
1. Blood product within 3 months prior to study entry;
2. Any live attenuated vaccine within 28 days prior to study entry;
3. Any subunit vaccine or inactivated vaccine within 14 days prior to study entry;
4. Any immunosuppressant within 6 month prior to study entry;
* Congenital malformation, developmental disorders, serious chronic diseases, autoimmune disease, immunodeficiency, serious cardiovascular disease, diabetes, hypertension that cannot be stabilized by medication, liver or kidney disease, or malignant tumor;
* History of asthma, thyroidectomy, angioneurotic edema, severe nervous system disease or mental illness; without spleen or splenectomy; diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities), or obvious bruising or coagulation disorders;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Axillaty temperature \> 37.0 °C;
* Any other factor that in the opinion of the investigator suggesting the volunteer is unsuitable for this study;
* Participants with the following conditions from day 0 - 28 would be included in the full analysis set (FAS), but would be excluded from the per protocol set (PPS):
1. Receipt of any other investigational or unregistered product (drug or vaccine);
2. Receipt of immunosuppressant (corticosteroid dosage that equivalent to or above 0.5 mg prednisone/kg weight/day) for \> 14 days, except for inhalant or locally administrated corticosteroid;
3. Receipt of immunoglobulin and/or blood product;
4. Newly diagnosed autoimmune disease or immunodeficiency (e.g., HIV infection);
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT02451969
Study Brief:
Protocol Section:
NCT02451969