Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95,000
- 试验地点
- 1
- 主要终点
- Rates of medically attended events: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
研究概览
简要总结
This is an observational post-marketing study conducted in children and adults immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites.
详细描述
Children and adults will be immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites. Using existing data on healthcare utilization, rates of medically attended events (MAEs) of interest will be evaluated in all eligible Q/LAIV recipients who are vaccinated in the Kaiser Permanente (KP) Northern California Health Care Plan during the 2013-2014 influenza season. Enrollment must include a minimum of 10,000 children 2 through 8 years of age; based on previous utilization of FluMist at NCKP, enrollment is expected to include approximately 80,000 children and adults 2 to 49 years of age.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •. Age 2 through 49 years at the time of vaccination (or index date for unvaccinated controls)
- •. Membership in the KP Health Care Plan for at least 12 months prior to vaccination/index date
- •. Continuous enrollment in KP Health Care Plan through 6 months following vaccination/index date.
排除标准
- 未提供
结局指标
主要结局
Rates of medically attended events: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
时间窗: From 1 to 42 days
Rates of medically attended events from 1 to 42 days: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Rates of medically attended events: hypersensitivity, seizures/convulsions
时间窗: From 0-3 days
Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions
Rates of medically attended events: narcolepsy/cataplexy
时间窗: From 1 to 180 days
Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy
次要结局
未报告次要终点