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 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT05074368
Eligibility Criteria:
Inclusion Criteria:
1. Males or females aged ≥20 to \<65 years old and have received adenovirus vector vaccine ChAdOx1-nCov-19 (Astra-Zeneca) or SARS-CoV-2 messenger RNA-1273 once within three months at least four weeks apart.
2. The subject must sign the subject's inform consent, or the subject's legal representative must understand and agree, then sign inform consent according to procedure above.
3. Healthy or existing medical condition is stable, and within 3 months before being included in the trial, he or she has not been hospitalized due to illness, and his or her condition is expected to remain stable during the trial period.
Exclusion Criteria:
1. Are currently pregnant or breastfeeding or plan to become pregnant within 30 days after the second dose of the trial vaccine.
2. Currently receiving or receiving other vaccines, including Streptococcus pneumoniae vaccine.
3. Have used any blood products or intravenous immunoglobulin within 12 weeks before entering the test. Receive concurrent immunosuppressive or immunomodulatory therapy (including steroid prednisone, targeted drugs such as infliximab, adalimumab, etanercept) within 12 weeks.
4. Immunosuppressive diseases or immune insufficiency states, including hematological malignancies, parenchymal organs, bone marrow transplant history or asplenia, autoimmune diseases (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, autoimmune thyroiditis, etc.) and human immunodeficiency virus infection.
5. Bleeding disease and assessed as a contraindication to prohibit the use of intramuscular injection or blood draw.
6. Other condition, such as physical examination or instability according to the trial investigator's judgment, or participation in this trial may adversely affect the safety of subjects, fail to comply with trial regulations, or interfere with trial evaluation indicators.
7. The subject is known to have been infected with severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT05074368
Study Brief:
Protocol Section:
NCT05074368