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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT06776367
Eligibility Criteria:
Inclusion Criteria:
* Are willing and able to provide voluntary electronic informed consent (eConsent) to participate in the study and written authorization (via electronic signature) for use and disclosure of protected health information
* Are able to understand and comply with planned study procedures, including specimen collection devices, use of eCOA application on a tablet or smartphone, and the wearable biometric device.
* Are ≥18 years old at time of informed consent
* Are available for all study data collection timepoints
* Completed primary approved/authorized COVID-19 vaccination series, defined as previous receipt of one of the following options:
* Doses of original monovalent mRNA or bivalent mRNA vaccine or a combination of the two,
* Doses of original monovalent Novavax COVID-19 Vaccine, alone or in combination with any mRNA vaccine doses; or
* Doses of Janssen COVID-19 Vaccine, alone or in combination with any mRNA or Original monovalent Novavax vaccine doses.
* Receipt of an FDA licensed/authorized COVID-19 vaccine within the previous 14 days or on the day of enrollment
Exclusion Criteria:
* Receipt or planned receipt of any of the following vaccines, on the same day or within 28 days prior to or after receipt of the FDA licensed/authorized COVID-19 vaccine:
* Shingrix (Zoster Vaccine Recombinant, Adjuvanted)
* Receipt of COVID-19 vaccine within 120 days prior to current vaccine
* Any disease or medical condition that, in the opinion of the Investigator or appropriate sub-investigator, is a contraindication to study participation
* Pregnant individuals (only exclusionary for the peripheral blood mononuclear cells \[PBMCs\] blood draws portion of the study)
* Currently participating or plans to participate in another clinical trial that is interventional and/or involving an investigational product.
* Are assessed by the Investigator as unsuitable for participation in this study for any reason.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06776367
Study Brief:
Protocol Section:
NCT06776367