NCT01153906已完成不适用
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 Years in the US
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,516
- 试验地点
- 1
- 主要终点
- Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.
研究概览
简要总结
The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.
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
- 9 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Both cohorts:
- •Have complete medical insurance coverage and pharmacy benefits.
- •Enrolled female health plan members for at least one year prior to study entry.
- •Age between 9 and 25 years at study entry.
- •Exposed cohort:
- •Subjects who have received at least one dose of Cervarix®, with or without any other US age-appropriate recommended vaccines.
- •Unexposed cohort:
- •No further specific inclusion criteria
排除标准
- •Both cohorts:
- •Subjects with a diagnostic code of any of the AID endpoints of interest during the one year prior to the index date.
- •Exposed cohort:
- •Subjects who received any dose of Gardasil® prior to the first dose of Cervarix®.
- •Unexposed cohort:
- •Subjects who receive any dose of Cervarix® prior to the index date.
结局指标
主要结局
Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.
时间窗: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.
次要结局
- Occurrence of new cases of confirmed systemic autoimmune diseases, organ-specific T-cell mediated autoimmune disease and organ-specific antibody-mediated autoimmune diseases.(During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.)
- Occurrence of new cases of psoriasis(During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.)
- Occurrence of new cases of fibromyalgia(During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.)
研究者
研究点 (1)
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