A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189,629
- 主要终点
- Incidence Rate of Syncope
研究概览
简要总结
This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.
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 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •3-Dose Safety Population
- •Female 9-26 years at the time of first dose of GARDASIL™
- •Completed the 3-dose regimen of GARDASIL™ per protocol
- •Pregnancy Safety Population
- •Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution
- •Autoimmune Safety Population
- •Female who has received at least one dose of GARDASIL™
- •Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™
- •Any Dose Safety Population
- •Female who has received at least one dose of GARDASIL™
排除标准
- •3-Dose Safety Population
- •Receives incomplete regimen of GARDASIL™
- •Completes the three dose regimen of GARDASIL™ in more than 12 months
- •Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3
- •Younger than 9 or older than 26 years of age at receipt of first dose
- •Pregnancy Safety Population
- •No record of pregnancy at the Managed Care Organization (MCO)
- •Autoimmune Safety Population
- •Member of the same MCO for less than 12 months prior to receiving the first dose
结局指标
主要结局
Incidence Rate of Syncope
时间窗: On day of each vaccination
Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
Incidence Rate of Cellulitis
时间窗: Within 14 days and within 60 days immediately after each vaccination
Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study.
次要结局
- Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy(First dose of Gardasil in pregnancy up to 6 months after birth)
- Number of Miscarriages Among Females Who Received Gardasil During Pregnancy(First dose of Gardasil in pregnancy up to pregnancy resolution)
- Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil(within 6 months immediately after each vaccination)