Exploratory Study to Assess the Use of Wearable Digital Sensors After mRNA Vaccination in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in a concurrent Moderna-sponsored vaccine clinical trial.
- •Investigator assessment that participant understands and is willing and physically able to comply with wearing the sensors and follow-up as outlined in the study protocol, including all procedures.
- •Participant has provided written informed consent for participation in this study, including all evaluations and procedures as specified in the study protocol.
排除标准
- •History of hypersensitivity or allergic reaction to medical adhesive or other history of skin irritation, that, in the opinion of the investigator, contraindicates their use of a wearable medical device.
- •Broken skin at the site of wearable location
- •Implanted, permanent pacemaker
结局指标
主要结局
Change From Pre-vaccination Baseline in Heart Rate up to 7 Days After Vaccination
时间窗: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Respiratory Rate up to 7 Days After Vaccination
时间窗: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Body Surface Temperature up to 7 Days After Vaccination
时间窗: 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
时间窗: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Digital Biomarker Level up to 7 Days After Vaccination
时间窗: Baseline, up to Day 7
Change From Pre-vaccination Baseline in Total Sleep Count Per 24 Hours up to 7 Days After Vaccination
时间窗: Baseline, up to Day 7
次要结局
未报告次要终点