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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT05542693
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Complete primary vaccination with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines, and at least one booster dose with Cominarty (Pfizer) or Covishield (Oxford/Astrazeneca) vaccines. The last duration being at least 4 before the study duration.
3. Adult in a healthy condition or with a stable health status if pre-existing medical history.
4. Sign informed consent, be able and willing to make the assessment, be accessible by telephone or in person by the local study team and willing to remain in the study area for the duration of the study
5. For women of childbearing age: a highly negative sensitive urinary pregnancy test during the inclusion visit AND use an effective contraceptive method.
Exclusion Criteria:
1. History of COVID-19 in the 30 days before study enrollment.
2. Participation in other clinical studies in the last 12 (two) months.
3. Receive or plan any immunization during the study, except the seasonal influenza vaccine, within 30 days of enrollment.
4. Receive a blood or immunoglobulin transfusion within 90 days before study enrollment;
5. Blood donation up to 30 days before inclusion in the study;
6. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immunomodulatory drugs.
7. History of autoimmune disease or immunosuppression.
8. Rash, tattoos, or any other skin condition that could adversely affect the vaccine injection site.
9. Body mass index (BMI) \> 35.
10. Known or suspected drug or alcohol abuse in the last 6 months;
11. History of previous anaphylaxis or severe allergic reactions to the vaccine, products known to contain polyethene glycol (PEG) or unknown allergens.
12. History of myocarditis or carditis.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05542693
Study Brief:
Protocol Section:
NCT05542693