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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT05172193
Eligibility Criteria:
Inclusion Criteria:
1. Adult males or females aged 18 years and above at the time of consent.
2. Participants who provide a voluntarily consent to participate in the study and sign the consent form.
3. Participants who have previously received homologous 2-dose of SARS-COV-2 Vaccine (either Vero Cell inactivated-Sinopharm SARS-COV-2 Vaccine, CoronaVac SARS-COV-2 Vaccine, or Cominarty/Pfizer mRNA COVID-19 Vaccine) authorized for emergency use, between 6 to 12 months post second prime vaccine dose prior to Day 1.
4. Participants who have negative results for swab SARS-COV-2 rapid antigen test.
Exclusion Criteria:
1. Participants who are unable to follow clinical and follow-up procedures.
2. Participants with acute fever with temperature above 38℃, coughing, breathing difficulty, chills, muscle ache, headache, sore throat, loss of smell, or loss of taste within 72 hours prior to the dosing.
3. Participants with a history of PCR-confirmed SARS-CoV-2 infection in the last 90 days prior to dosing.
4. Female who are pregnant or breastfeeding.
5. Participants with a history of hypersensitivity or allergic reactions including anaphylaxis.
6. Participants with immune dysfunction, including immunodeficiency disorder, or family history of such conditions, except HIV-positive participants in stable/well-controlled condition.
7. Participants who received chronic administration (defined as more than 14 continuous days) of immunosuppressant medication such as immunomodulator, immune-modifying drug, immunoglobulin, immunotherapy, chemotherapy, systemic corticosteroid, etc. except topical steroids or short-term oral steroids (course lasting ≤ 14 days), or blood-derived products in the last 90 days prior to dosing.
8. Participants with a current clinically significant chronic and unstable cardiovascular, endocrine, gastrointestinal, hepatic (including hepatitis B and C), renal, neurological, respiratory, psychiatric or other medical disorders not excluded by other exclusion criteria , that are assessed by the investigator as being clinically unstable within the prior 90 days as evidenced by:
1. Hospitalization for the condition, including day surgical interventions
2. New significant organ function deterioration
3. Needing addition of new treatments or major dose adjustments of current treatments (mild or moderate well-controlled comorbidities are allowed)
9. Participants with hemophilia or people using anticoagulants who are at a risk of serious bleeding from IM injection.
10. Participants with a current dependent on antipsychotic drugs and narcotic analgesics, or suspected of alcohol or drug dependency.
11. Participants who have received or plans to receive other vaccination(s) within 28 days prior to or during study duration (except for influenza vaccine which is not allowed within 14 days before, or 4 weeks after final dose of IP).
12. Participants who have received or have plans to receive other investigational drug(s) while participating in another clinical study or bioequivalence study within 28 days prior to vaccination. -
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05172193
Study Brief:
Protocol Section:
NCT05172193