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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT06761612
Eligibility Criteria:
Inclusion Criteria:
1. People ≥3 years of age at time of enrollment.
2. Willing and able to provide informed consent, or assent in pediatric population, if appropriate, prior to initiation of study procedures.
3. Able to understand and comply with planned study procedures.
4. Available for all study data collection points.
5. Receipt of the most recent FDA-licensed and authorized COVID-19 vaccine (i.e., the 2024-2025 Moderna COVID-19 vaccine or the 2024-2025 Pfizer-BioNTech COVID-19 vaccine which includes the KP.2 strain of the JN.1-lineage vaccine), as recommended by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) and outlined in the FDA's updated guidance, administered within 3 days of enrollment.
PBMC cohort only:
People ages ≥18 years at time of enrollment. Available for first blood sample collection within 1 day of vaccine.
Exclusion Criteria:
1. Currently participating or plans to participate in another clinical trial involving an investigational product before completing this study.
2. Planned to receive another COVID-19 vaccine within 180 days.
3. Receipt of COVID-19 vaccination within 180 days prior to current vaccination.
4. Receipt of Shingrix vaccine in the 28 days prior to the COVID-19 vaccination or planned receipt of Shingrix vaccine within 28 days after receipt of COVID-19 vaccination.
5. Self-report of recently confirmed COVID-19 infection within 30 days.
6. Any disease or medical condition that, in the opinion of the principal investigator or sub-investigator, is a contraindication to study participation.
PBMC cohort only:
Confirmed positive urine pregnancy test at study visits per Schedule of Activities.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT06761612
Study Brief:
Protocol Section:
NCT06761612