- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01421251
H1N1 Vaccine Safety in Manitoba, Canada
The Safety of GSK Biological's H1N1 Pandemic Vaccine in Manitoba, Canada
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다, R3B 3P5
- International Centre for Infectious Diseases
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- All 6-month or older Manitoba residents are eligible
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
---|
Matched cohorts - population based
Two cohorts: vaccinated individuals are matched to unvaccinated individuals on the basis of age, sex, and postal code of residence.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adverse Effects of H1N1 vaccination
기간: One year
|
Incidence rate ratios of certain vaccination adverse effects
|
One year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Incidence Ratios of Adverse Effects
기간: One year
|
Standardized incidence ratios of certain adverse events in relation to history of H1N1 vaccination.
|
One year
|
Sex-specific adverse effects of vaccination
기간: One year
|
Determination of sex-specific adverse effects following H1N1 vaccination.
|
One year
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Salah Mahmud, M.D., Ph.D., University of Manitoba
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
H1N1 인플루엔자에 대한 임상 시험
-
Fraunhofer, Center for Molecular BiotechnologyWalter Reed Army Institute of Research (WRAIR); Defense Advanced Research Projects Agency완전한
-
Canadian Critical Care Trials GroupCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated Foundation 그리고 다른 협력자들종료됨
-
PHAC/CIHR Influenza Research NetworkGlaxoSmithKline; CHU de Quebec-Universite Laval; The Ottawa Hospital; Hamilton Health Sciences... 그리고 다른 협력자들완전한신종 인플루엔자 A/H1N1
-
Butantan InstituteUniversity of Sao Paulo; Insituto Adolfo Lutz; Centro de Referencia e Treinamento em DST/AIDS완전한면역 저하 환자 | 유행성 인플루엔자 A(H1N1) 백신의 안전성 | 유행성 인플루엔자 A(H1N1) 백신의 면역원성브라질
-
National Taiwan University Hospital알려지지 않은
-
The University of Hong KongQueen Elizabeth Hospital, Hong Kong; Queen Mary Hospital, Hong Kong; Pamela Youde Nethersole... 그리고 다른 협력자들완전한
-
Medical University of Graz완전한
-
National Heart, Lung, and Blood Institute (NHLBI)완전한
-
David ScheifeleCanadian Institutes of Health Research (CIHR); PHAC/CIHR Influenza Research Network완전한