Cervarix Long-term Safety Surveillance (PGRx)
Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
調査の概要
詳細な説明
PGRx is an information system that intends to bridge the resource gap to assess the effect of a drug on the risk of adverse events that are infrequent and/or with a long delay of onset. It uses some characteristics of the ad hoc case-control or case-referent design, transposed on a prospective, on-going, population-based recruitment plan. This particular design is called here systematic case-referent design in contrast to the ad hoc case-control or case-referent methodology. The PGRx information system is based on the routine and targeted recruitment of cases of a series of pathologies, compared to population-based referents for the study of exposure to a wide variety of drugs. Drug exposure ascertainment is obtained from two different sources in the PGRx.
system: A) A structured patient interview (telephone-administered questionnaire) B) The medical data form with the computerized medical prescriptions (interview guide)
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Male and female
- Age 14 to 79 years-old (included)
- Patient residing in France
- Patient accepting to participate in the study
- Patient can read and respond to a telephone interview
Exclusion Criteria:
- Prior reported history of the disease
- Patient or Patient's parent cannot read the interview guide or answer a telephone interview questionnaire in French
- Refusal to participate
研究計画
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：ケースコントロール
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Case Group
Subjects in this group are incident cases (i.e.
newly diagnosed subjects) reported as having occurred in the previous twelve months before the recruitment consultation.
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3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
PGRx information system
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Control Group
Subjects selected from the pool of potential referents reported by physicians in general practice, who meet the same general inclusion and exclusion criteria as the cases.
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3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
PGRx information system
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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 |
時間枠 |
|---|---|
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To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
時間枠：At Month 36
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At Month 36
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To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of myositis.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis
時間枠：At Month 36
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At Month 36
|
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To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
時間枠：At Month 36
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At Month 36
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 112677
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。
Cervarixの臨床試験
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GlaxoSmithKline完了
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International Vaccine InstituteMinistry of Health, Thailand招待による登録
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GlaxoSmithKline完了子宮頸部上皮内腫瘍形成 | パピローマウイルス感染症台湾, ドイツ, コロンビア, ホンジュラス, パナマ
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GlaxoSmithKline完了
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University Hospital, Ghent完了