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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT05743335
Eligibility Criteria:
Main Inclusion Criteria
* Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
* Age: 18 years of age or older, at screening.
* Status: Healthy subjects.
* Subjects must have completed the full doses for primary vaccination with an approved SARS-CoV-2 vaccine and may have received booster dose(s), with the last vaccination (can be 2nd dose of primary vaccination or booster dose) having occurred at least 4 months prior to enrollment.
Main Exclusion Criteria
* Current or prior symptomatic or asymptomatic SARS-CoV-2 infection confirmed by an approved or authorized rapid antigen test on Day 1 or within 4 months prior to Day 1.
* Subjects with significant exposure (as defined by current CDC guidance) to someone with laboratory confirmed SARS-CoV-2 infection or COVID-19 with the past 14 days prior to the Screening visit.
* Subjects with fever or signs of acute infection at the time of enrollment and vaccination.
* Subjects who are taking medications that may prevent or treat COVID-19.
* Subjects who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 within 4 months before Day 1.
* Subjects with history of myocarditis or pericarditis, or with AEs after mRNA vaccination that are in nature and severity beyond the common AEs expected and necessitating medical intervention.
* Subjects with active or suspected immunosuppression, immunodeficiency, or autoimmune disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05743335
Study Brief:
Protocol Section:
NCT05743335