A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
2014年7月21日 更新者：MedImmune LLC
A Post Marketing Evaluation of the Effectiveness of the Risk Minimization Plan For Use of FluMist Among Children Less Than 5 Years of Age
This is a retrospective cohort study of children included in a large medical insurance claims database.
調査の概要
詳細な説明
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
- Children 24-59 months of age with a claim associated with a diagnosis of asthma
- Children 24-59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
- Children 24-59 months of age with immunosuppression
- 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
- To explore the rationale for FluMist immunization of pediatric populations that are excluded from recommended usage by characterizing the use in these populations
研究の種類
観察的
入学 (実際)
321697
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
North Carolina
-
Research Triangle、North Carolina、アメリカ
- Research Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Children < 60 months of age.
説明
- Children less than 24 months of age during August through January/February.
Children <24 to 59 months of age during August through January/February, with:
- two outpatient claims for asthma, or
- one inpatient/emergency room claim for asthma, or
- one outpatient claim for asthma and at least one SABA prescription during a defined 12-month period.
- Children <24 to 59 months of age during August through January/February, without any claims associated with a diagnosis of asthma, but with at least one dispensing for SABA, as indicated by pharmacy claims during a defined 12-month period.
- Children 24 to 59 months of age during August to January/February with evidence of immunosuppression prior to the date of influenza vaccination based on available medical and pharmacy claims.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：回顧
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
1
Children less than 24 months of age
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
|
2
Children 24 to 59 months of age with a claim associated with a diagnosis of asthma
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
|
3
Children 24 to 59 months of age without a claim associated with a diagnosis of asthma, but with dispensed medication for wheezing
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
|
4
Children 24-59 months of age with immunosuppression
|
There were no interventions.
No subjects were enrolled in this retrospective database study.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
FluMist Use in Participants up to 59 Months of Age
時間枠：2009-2010
|
Among participants up to 59 months of age who received any flu vaccine, number who received FluMist
|
2009-2010
|
|
Vaccinating Physician Specialty: Pediatrician or Pediatric Specialist
時間枠：2009-2010
|
Specialty of vaccinating physician who provided FluMist.
|
2009-2010
|
|
Vaccinating Physician Specialty: General/Family Practitioner
時間枠：2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
|
Vaccinating Physician Specialty: Other
時間枠：2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
|
Vaccinating Physician Specialty: Unknown
時間枠：2009-2010
|
Specialty of vaccinating physician who provided FluMist
|
2009-2010
|
|
Geographic Region: Northeastern
時間枠：2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Geographic Region: North Central
時間枠：2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Geographic Region: Southern
時間枠：2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Geographic Region: Western
時間枠：2009-2010
|
Geographic region of parents' residence among participants receiving FluMist
|
2009-2010
|
|
Number of Outpatient Visits: 0
時間枠：2009-2010
|
Among participants vaccinated with FluMist, the number who had 0 outpatient visits in the 3 months prior to vaccination
|
2009-2010
|
|
Number of Outpatient Visits: 1
時間枠：2009-2010
|
Among participants vaccinated with FluMist, the number who had 1 outpatient visit in the 3 months prior to vaccination
|
2009-2010
|
|
Number of Outpatient Visits: 2 or More
時間枠：2009-2010
|
Among participants vaccinated with FluMist, the number who had 2 or more outpatient visits in the 3 months prior to vaccination
|
2009-2010
|
|
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 0
時間枠：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.
|
2009-2010
|
|
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 1
時間枠：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.
|
2009-2010
|
|
Number of Days With a Respiratory Claim in 28 Days Prior to Vaccination: 2 or More
時間枠：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.
|
2009-2010
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年10月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年3月1日
試験登録日
最初に提出
2008年2月20日
QC基準を満たした最初の提出物
2008年2月20日
最初の投稿 (見積もり)
2008年2月29日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年8月12日
QC基準を満たした最後の更新が送信されました
2014年7月21日
最終確認日
2014年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。