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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT04790851
Eligibility Criteria:
Inclusion criteria:
* ≥18 years old when enrolled;
* Participants signing the informed consent;
* Being able to participate in all planned follow-ups and accomplish all research procedures including completing a diary card and coming back for interview;
* Having not been administered any pneumonia vaccine or COVID-19 vaccine, and having not been administered an influenza vaccine in the current season before enrollment;
* ≥14 days from the most recent vaccination;
* Before enrollment, the body temperature is ≤37.0C as confirmed by medical history and clinical examination.
Exclusion criteria for the first dose:
* Having a history of COVID-19 or a positive nucleic acid test for COVID-19;
* Having a history or a family history of allergy, convulsion, epilepsy, brain disease, or mental illness;
* Being allergic to any component of vaccines, or having a history of severe allergic reaction to any vaccine;
* Having immunodeficiency disorder, during treatment of malignant tumor, having immunodeficiency induced by immunosuppressants (oral steroid hormones) or HIV, or having a family member with close contact who suffers from congenital immune disorder;
* Having injection of non-specific immunoglobulin within 1 month prior to enrollment;
* Having acute febrile illness or communicable disease;
* Having a history of confirmed thrombocytopenia or other coagulation disorders, which may cause contraindications for a subcutaneous injection;
* Having severe chronic disease or acute exacerbation of chronic disease, or having uncontrolled hypertension or diabetes;
* Having various infectious, pyogenic, or allergic skin diseases;
* Women in pregnancy or lactation or participants who plan for a baby within 3 months after vaccination should delay the vaccination;
* Having any condition that may affect trial assessment as determined by researchers.
Exclusion criteria for the second dose:
* Having any serious adverse event related to the first dose vaccination;
* After vaccination, having systemic adverse reaction or allergic reaction with a severity of grade 3 or higher as determined by researchers;
* Having a newly emerging condition that meets the exclusion criteria for the first dose;
* Having any condition that may affect trial assessment as determined by researchers.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04790851
Study Brief:
Protocol Section:
NCT04790851