NCT05440318

Use of Wearable Digital Sensors After mRNA Vaccination in Adults

Exploratory Study to Assess the Use of Wearable Digital Sensors After mRNA Vaccination in Healthy Adults

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 62 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-16
• Primary completion: 2023-02-07
• Completion: 2023-02-07
• First posted: 2022-06-30
• Last updated: 2023-04-04

Locations

4 sites across 1 country: United States