ACTRN12622000506796已完成未知
ong-term outcomes of myocarditis and pericarditis after Pfizer-BioNTech (Comirnaty) COVID-19 vaccination in children and adults
Medsafe0 个研究点目标入组 323 人开始时间: 2022年3月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 323
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 Years 至 o limit（—）
- 性别
- All
入选标准
- •1) Adults and children 12 years of age or older with a clinical diagnosis of myocarditis and/or pericarditis (includes myopericarditis), after any dose of the Pfizer vaccine, and their healthcare providers.
- •2) A report of myocarditis and/or pericarditis has been submitted to the Centre for Adverse Reactions Monitoring (CARM) by the person themselves, or by someone on their behalf (such as a healthcare professional or family member).
- •3) Participants will not be required to meet specific diagnostic criteria, such as the CDC criteria, to be eligible.
- •4) Myocarditis and/or pericarditis diagnosed up to and including 28 February 2022, and at least 3 months prior to the survey (minimum of 3 months post-diagnosis).
排除标准
- •1) Children <12 years of age.
- •2) People who have not received a clinical diagnosis of myocarditis and/or pericarditis. This includes self-diagnosis, or where a diagnosis of myocarditis or pericarditis was considered as part of the differential diagnosis but was not given as a final diagnosis.
- •3) Myocarditis and/or pericarditis diagnosed after 28 February 2022, and/or less than 3 months ago by the end of the specified recruitment period.
- •4) People who experienced myocarditis and/or pericarditis after a third or subsequent dose of the Pfizer vaccine.
- •5) People who did not receive the Pfizer vaccine prior to being diagnosed with myocarditis or pericarditis.
- •6) People who experienced myocarditis and/or pericarditis after vaccination with another COVID-19 vaccine (for example, the AstraZeneca vaccine).
- •7) People who have not provided sufficient contact information in CARM report to be able to make initial contact.
- •8) Circumstances that interfere with the participant’s ability to give informed consent (including a diminished understanding or comprehension of English and an interpreter unavailable).
研究者
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