A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321,697
- 试验地点
- 1
- 主要终点
- Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
研究概览
简要总结
This is a retrospective cohort study of children included in a large medical insurance claims database.
详细描述
-
To evaluate the rate of FluMist administration compared to other influenza vaccine use in the following pediatric populations:
-
Children younger than 24 months of age
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Children 24-59 months of age with a claim associated with a diagnosis of asthma
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Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
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Children 24-59 months of age with immunosuppression
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To describe, in children in the above populations who receive FluMist, the type and number of Emergency Room visits or hospitalizations associated with an insurance claim within 42 days of receiving FluMist
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To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Children less than 24 months of age
干预措施: No Intervention (Drug)
2
Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
干预措施: No Intervention (Drug)
3
Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
干预措施: No Intervention (Drug)
4
Children 24-59 months of age with immunosuppression
干预措施: No Intervention (Drug)
结局指标
主要结局
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
时间窗: 2009-2010
Specialty of vaccinating physician who provided FluMist.
Number of Outpatient Visits: 1
时间窗: 2009-2010
Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
Geographic Region: Northeastern
时间窗: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Geographic Region: North Central
时间窗: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Number of Outpatient Visits: 2 or More
时间窗: 2009-2010
Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
FluMist Use in Participants up to 59 Months of Age
时间窗: 2009-2010
Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
Vaccinating Physician Specialty: General/Family Practitioner
时间窗: 2009-2010
Specialty of vaccinating physician who provided FluMist
Vaccinating Physician Specialty: Unknown
时间窗: 2009-2010
Specialty of vaccinating physician who provided FluMist
Geographic Region: Southern
时间窗: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Number of Outpatient Visits: 0
时间窗: 2009-2010
Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
时间窗: 2009-2010
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
Vaccinating Physician Specialty: Other
时间窗: 2009-2010
Specialty of vaccinating physician who provided FluMist
Geographic Region: Western
时间窗: 2009-2010
Geographic region of parents' residence among participants receiving FluMist
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
时间窗: 2009-2010
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
时间窗: 2009-2010
Among participants vaccinated with FluMist, the number of days with a respiratory claim (asthma, acute respiratory distress, bronchospasm, influenza, respiratory syncytial virus, bronchiolitis, bronchitis, pneumonia, croup, sinusitis, adenovirus infection, coxsackie virus infection, rhinovirus infection, nasopharyngitis, laryngitis and tracheitis, upper respiratory infection, cough) in the 28 days prior to vaccination.
次要结局
未报告次要终点