Post-licensure Observational Safety Surveillance Study of Quadrivalent Meningococcal ACWY Conjugate Vaccine MenACWY-CRM (Menveo) Vaccination in Children 2 Through 10 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 393
- 试验地点
- 1
- 主要终点
- Frequency (n, %) for all serious medically attended events and events of interest
研究概览
简要总结
The purpose of this study is to summarize the occurrence of incident serious medically attended events and events of interest up to 1 year following MenACWY-CRM vaccination administered as part of routine clinical care. This US FDA post-marketing commitment study is an open-label, descriptive, epidemiological safety surveillance study of MenACWY-CRM vaccine in subjects 2 to 10 years of age within a large US Healthcare Maintenance Organization. The 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.
详细描述
This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited.
Events of Interest: Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Intentional Injury
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
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Registered with the HMO for at least 6 months prior to vaccination.
- •Between the ages of 2 and 10 years (inclusive - i.e. has not reached their 11th birthday) at the time of the vaccination.
- •Received any MenACWY-CRM vaccination during the vaccination period at the participating centers.
排除标准
- 未提供
结局指标
主要结局
Frequency (n, %) for all serious medically attended events and events of interest
时间窗: Observational period of 1 year following date of vaccination of that individual.
Incidence (n per person years, 95% CI) for all serious medically attended events and events of interest
时间窗: Observational period of 1 year following date of vaccination of that individual.
Timing relative to vaccination date (mean days (SD)) for all serious medically attended events and events of interest
时间窗: Observational period of 1 year following date of vaccination of that individual.
次要结局
未报告次要终点