Retail COVID-19 Study (NCT06761612) | Clinical Trial Compass
CompletedNot Applicable
Retail COVID-19 Study
United States2,519 participantsStarted 2024-10-19
Plain-language summary
Despite the availability of vaccines, there remains a need to identify specific immune responses that correlate with protection against SARS-CoV-2 infection. Additionally, the operational capability of retail pharmacy infrastructure to collect longitudinal data and biological samples needs to be assessed. This study aims to fill these gaps by determining correlates of protection (CoP), assessing the infrastructure's capability, and examining demographic and geographic differences in participation.
Who can participate
Age range
3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. People ≥3 years of age at time of enrollment.
. Willing and able to provide informed consent, or assent in pediatric population, if appropriate, prior to initiation of study procedures.
. Able to understand and comply with planned study procedures.
. Available for all study data collection points.
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum S protein-specific binding antibody (bAb) concentrations (peak and exposure proximal assessments) Serum SARS-CoV-2 specific neutralizing antibody (nAb) titers (peak and exposure proximal assessments);
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
2
Valid Viable specimens for SARS-CoV-2 testing
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5).
3
Number of viable specimens for laboratory analysis
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
4
Number of valid specimens for CoP testing
Timeframe: Day 1, Day 31, Day 91, Day 181, and Day 366 (i.e., visits 1-5)
Trial details
NCT IDNCT06761612
SponsorBiomedical Advanced Research and Development Authority
. Currently participating or plans to participate in another clinical trial involving an investigational product before completing this study.
. Planned to receive another COVID-19 vaccine within 180 days.
. Receipt of COVID-19 vaccination within 180 days prior to current vaccination.
. 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.
. Self-report of recently confirmed COVID-19 infection within 30 days.
. Any disease or medical condition that, in the opinion of the principal investigator or sub-investigator, is a contraindication to study participation.