General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During the Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,538
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Serious Adverse Events (SAE)
研究概览
简要总结
This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine.
The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine.
The number of visits to the clinic will depend on the clinic's standard practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study.
排除标准
- 未提供
结局指标
主要结局
Percentage of Participants with Serious Adverse Events (SAE)
时间窗: 11 months (From 28 days to 12 months after the second vaccination)
An SAE is defined as any untoward medical occurrence that: Results in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event.
次要结局
- Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study(11 months (From 28 days to 12 months after the second vaccination))
- Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator(11 months (From 28 days to 12 months after the second vaccination))
- Number of Participants who Developed COVID-19 during the Study(11 months (From 28 days to 12 months after the second vaccination))