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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT05016934
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Previously totally immunized, I.e., two doses for Corona Vac (Sinovac) or ChAdOx1 (AZ 1222, Astra Zeneca, and one dose for Ad26.Co2.S (Janssen) vaccines at least three months before enrollment
* Negative RT-PCR for SARS-CoV-2 at the moment of triage
* No previous history of laboratory confirmed Covid-19
Exclusion Criteria:
* Pregnancy
* Participation in other vaccine trial
* Active decompensated chronic condition, namely, cardiovascular, respiratory, neurological, metabolic or hepatic diseases
* Any immunocompromise condition (primary immunodeficiencies, auto-immune diseases, long-term use of corticosteroids, solid organ transplant recipients, hematopoietic stem-cell transplant recipients, human-immunodeficiency virus active infection)
* Active cancer
* Hepatitis B or C
* History of allergic reactions to any vaccine component, including excipients and preservatives (neomycin, streptomycin, polymyxin B, eggs
* Blood donation in the past 4 weeks before screening
* Received blood product in the past 3 months before screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05016934
Study Brief:
Protocol Section:
NCT05016934