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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT05409261
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 45 years old or 55 years and older
* Be eligible to receive one of the study vaccines as part of the trial
* Understand and agree to comply with study procedures (visits, telephone calls)
* Agree not to participate in any other vaccine study during the time of the study
* Give written informed consent prior to any examination performed as part of the trial
Exclusion Criteria:
* Positive SARS-CoV-2 antigenic test
* Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
* History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion
* Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C)
* Pregnant or breastfeeding woman
* Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)
* Anti-coagulant treatment
* Immunosuppressive treatment
* Contraindication to the proposed vaccine (according to RCP)
* Previously received at least one injection of a SARS-CoV-2 vaccine
* Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
* A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
* Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05409261
Study Brief:
Protocol Section:
NCT05409261