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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05231005
Eligibility Criteria:
Inclusion Criteria:
1. Age: Volunteer must be at least 18 years of age, at the time of signing the informed conset.
2. Sex: Male or Female. All female volunteers of reproductive age will be requested to use contraceptive measures for the two months following enrolment.
3. Received 3 doses of BNT162b2 with the 3rd dose at least 4 months previously.
4. Have a serology test within the previous 3 months of 700 BAU or less.
5. Responded to the previous vaccine doses, i.e. at least one IgG\>100.
6. Medical Conditions: Volunteers with any medical condition are allowed, as long as they adhere to the criteria above.
7. Agreed to attend all visits and signed the informed consent -
Exclusion Criteria:
\- 1. Had previous SARS-CoV-2 infection (detected by either PCR, anti-S IgG before the 1st vaccine dose, anti-N IgG at any stage).
2\. Had an allergic response to any of the previous BNT162b2 doses. 3. Has history of myopericarditis. 4. Report that they do not feel well or have a fever on the day of vaccination. 5. Pregnant on day of recruitment.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05231005
Study Brief:
Protocol Section:
NCT05231005