H1N1 Vaccine Safety in Manitoba, Canada
The Safety of GSK Biological's H1N1 Pandemic Vaccine in Manitoba, Canada
調査の概要
状態
条件
詳細な説明
The objective of this study is to examine the safety of the H1N1 vaccine administered in Manitoba during the second wave of the pandemic (Oct 2009-Mar 2010) by describing the age sex specific and age standardized incidence rates of certain vaccination adverse events in the vaccinated populations during the first 6 months of follow-up and to compare the rates with those in the non-vaccinated population and the general Manitoba population.
Study design The proposed study will be a retrospective analysis of population based cohorts of subjects whose vaccination status and health events before and after H1N1 vaccination are recorded in various Manitoba databases. All H1N1 vaccinated and unvaccinated individuals are eligible to be included in the study population. There will be no exclusion criteria. The list of specific adverse events of special interest (AESIs) includes: anaphylaxis, Bell's palsy, convulsions, demyelination, encephalitis, Guillain-Barré syndrome, neuritis, vasculitis and various pregnancy outcomes.
Vaccinated individuals will be identified using the Manitoba Immunization Monitoring System (MIMS). Unvaccinated individuals will be identified using the Population Registry. AESIs and other clinically relevant information will be determined using hospital, physician claim and DPIN databases.
The primary statistical analysis will be a comparison of the overall and age specific rates of deaths and AESIs in the vaccinated cohort relative to the non-vaccinated cohort. The two cohorts will be matched on age (month and year of birth), sex and postal code of residence. The analyses will be stratified by specific subgroups: (e.g. pregnant women, persons who are immune suppressed or with autoimmune disorders).
The observed number of events will be determined from the date of first vaccination for each subject and the matched control until the first occurrence of a specific event. Information on events for each person will be derived from the medical claims and hospitalization databases. The person years at risk will be calculated from the date of first vaccination until the first occurrence of the specific event, emigration from Manitoba, or until 6 months after vaccination. Incidence rate ratios and 95% confidence intervals will be calculated by comparing the standardized incidence rates in the vaccinated cohort with those in the matched non vaccinated cohort.
In addition, the observed number of deaths and AESIs in the total vaccinated population and in specific subgroups (as above) will be compared to the expected numbers based on the age sex specific rates in the general Manitoba population. Similar to the matched cohort component, the observed number of events will be determined for the vaccinated individuals from the date of first vaccination until the first occurrence of a specific event, and the person years at risk will be calculated from the date of first vaccination until the first occurrence of the specific event, emigration from Manitoba, or until 6 months after vaccination. The background rate of targeted events will be calculated utilizing information from the mortality, physician claims and hospitalization databases for the total population in Manitoba for the period 2004 2008. Since the risk of some of the events is low, calculating the age sex specific rates based on five years of data will increase the stability of the rates. The expected number of events will be calculated by multiplying the person years at risk by the age sex specific background rate of each targeted event. Standardized incidence ratios (SIRs) or mortality ratios (SMRs) will be calculated as the number of observed events over the number of expected events, with 95% confidence intervals. To assess the absolute burden of an eventual excess in observed number of events the absolute difference between the observed and expected number of events for certain AESIs will also be calculated.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
Manitoba
-
Winnipeg、Manitoba、カナダ、R3B 3P5
- International Centre for Infectious Diseases
-
-
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:
- All 6-month or older Manitoba residents are eligible
Exclusion Criteria:
- None
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
コホートと介入
グループ/コホート |
---|
Matched cohorts - population based
Two cohorts: vaccinated individuals are matched to unvaccinated individuals on the basis of age, sex, and postal code of residence.
|
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 |
---|---|---|
Adverse Effects of H1N1 vaccination
時間枠:One year
|
Incidence rate ratios of certain vaccination adverse effects
|
One year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Incidence Ratios of Adverse Effects
時間枠:One year
|
Standardized incidence ratios of certain adverse events in relation to history of H1N1 vaccination.
|
One year
|
Sex-specific adverse effects of vaccination
時間枠:One year
|
Determination of sex-specific adverse effects following H1N1 vaccination.
|
One year
|
協力者と研究者
協力者
捜査官
- 主任研究者:Salah Mahmud, M.D., Ph.D.、University of Manitoba
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
追加の関連 MeSH 用語
その他の研究ID番号
- ICID-2011-H1N1-01
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。
H1N1 インフルエンザの臨床試験
-
Canadian Critical Care Trials GroupCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated Foundation と他の協力者終了しました
-
Fraunhofer, Center for Molecular BiotechnologyWalter Reed Army Institute of Research (WRAIR); Defense Advanced Research Projects Agency完了
-
PHAC/CIHR Influenza Research NetworkGlaxoSmithKline; CHU de Quebec-Universite Laval; The Ottawa Hospital; Hamilton Health Sciences Corporation と他の協力者完了新型インフルエンザA/H1N1
-
Butantan InstituteUniversity of Sao Paulo; Insituto Adolfo Lutz; Centro de Referencia e Treinamento em DST/AIDS完了免疫不全患者 | パンデミックインフルエンザ A (H1N1) ワクチンの安全性 | パンデミックインフルエンザ A (H1N1) ワクチンの免疫原性ブラジル
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Pamela Youde Nethersole Eastern... と他の協力者完了
-
National Taiwan University Hospitalわからない
-
The University Clinic of Pulmonary and Allergic...完了
-
Hadassah Medical Organizationわからない
-
Taipei Medical University WanFang Hospitalわからない
-
National Heart, Lung, and Blood Institute (NHLBI)完了