An observational study in Healthy Participants, sponsored by ModernaTX, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by ModernaTX, Inc. · Observational
The purpose of this study is to explore the physiological and behavioral impact of the immune response to vaccines after receipt of investigational or approved messenger ribonucleic acid (mRNA) vaccines using wearable medical sensors, with the potential of establishing a digital biomarker of vaccine response due to stimulation of the immune system.
Participants will be provided wearable medical sensor equipment and instructions at the start of the study. Participants will have access to device support throughout the study period. The wireless medical devices will be applied prior to vaccination in the concurrent Moderna-sponsored vaccine trial in order to establish an initial baseline of participants' daily physiological patterns.
ModernaTX, Inc. is the lead sponsor of 112 studies on the registry; 14 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 32 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants enrolled in the multi-center, concurrent Moderna-sponsored vaccine trial will be provided the opportunity to enroll in this study. Participants will be screened for eligibility based on their concurrent enrollment in the vaccine trial.
Exclusion Criteria:
Participants will wear 2 devices during the specified monitoring period. They will wear both a small patch on their chest that captures continuous electrocardiogram (ECG), accelerometry, and temperature data, and a modified smartwatch measuring continuous photoplethysmography (PPG) and accelerometry data.
Device: Wireless wearable digital devices
Wireless wearable digital devices (including a small patch, modified watch, and datahub smartphone with electronic Patient Reported Outcomes \[ePRO\] capability) will be provided to each participant enrolled in the study.
Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Respiratory Rate up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Body Surface Temperature up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Total Sleep Count Per 24 Hours up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Moderate to Vigorous Physical Activity Total Minutes Per 24 Hours up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Digital Biomarker Level up to 7 Days After Vaccination
Time frame: Baseline, up to Day 7
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ModernaTX, Inc.