Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
2017年6月9日 更新者：Merck Sharp & Dohme LLC
A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
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™.
調査の概要
状態
完了
研究の種類
観察的
入学 (実際)
189629
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
9年歳以上 (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
女性
サンプリング方法
確率サンプル
調査対象母集団
Managed Care Organizations (MCO) databases
説明
Inclusion Criteria:
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™
Exclusion Criteria:
3-Dose Safety Population
- Male
- 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
- Males
- 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
- Male
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：見込みのある
コホートと介入
グループ/コホート |
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3-Dose Safety Population (Primary)
Females between ages 9 to 26 at receipt of the first dose of GARDASIL who are members of the participating MCOs and have completed the 3-dose regimen of GARDSIL vaccination with 12 months.
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Pregnancy Safety Population
Females who received at least one dose of GARDASIL during pregnancy.
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Autoimmune Safety Population
Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL.
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Any Dose Safety Population (Secondary)
Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence Rate of Syncope
時間枠：On day of each vaccination
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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.
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On day of each vaccination
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Incidence Rate of Cellulitis
時間枠：Within 14 days and within 60 days immediately after each vaccination
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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.
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Within 14 days and within 60 days immediately after each vaccination
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy
時間枠：First dose of Gardasil in pregnancy up to 6 months after birth
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Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
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First dose of Gardasil in pregnancy up to 6 months after birth
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Number of Miscarriages Among Females Who Received Gardasil During Pregnancy
時間枠：First dose of Gardasil in pregnancy up to pregnancy resolution
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Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy.
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First dose of Gardasil in pregnancy up to pregnancy resolution
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Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil
時間枠：within 6 months immediately after each vaccination
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Autoimmune cases were defined as newly diagnosed cases within 6 months after any dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest. |
within 6 months immediately after each vaccination
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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。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012 Feb;271(2):193-203. doi: 10.1111/j.1365-2796.2011.02467.x. Epub 2011 Nov 15.
- Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451.
便利なリンク
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 (実際)
2007年2月6日
一次修了 (実際)
2010年12月13日
研究の完了 (実際)
2010年12月13日
試験登録日
最初に提出
2010年2月26日
QC基準を満たした最初の提出物
2010年3月1日
最初の投稿 (見積もり)
2010年3月2日
学習記録の更新
投稿された最後の更新 (実際)
2017年7月11日
QC基準を満たした最後の更新が送信されました
2017年6月9日
最終確認日
2017年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- V501-031
- 2010_019
- EP08014.031 (その他の識別子：Merck)
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。