Post-authorisation Safety Study (PASS) of Influenza Vaccine in United Kingdom (UK)
2016년 2월 11일 업데이트: GlaxoSmithKline
European Medicines Agency (EMA) Post-authorisation Safety Study of Influenza Vaccine
The purpose of this study is to conduct a pilot study to explore the potential use of routinely collected data in General Practitioner (GP) practices to conduct enhanced safety surveillance of seasonal influenza vaccines in the UK, as recommended in the EMA interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU.
연구 개요
상세 설명
Data routinely collected as part of clinical consultations in primary care will be extracted from nine General Practitioner (GP) practices in order to estimate medically attended Adverse Events of Interest (AEIs), for people who have received an influenza vaccine.
This study will also actively follow patients who were exposed to seasonal influenza vaccination for 7 days in three of the nine GP practices using a customised card-based adverse drug reaction reporting system, in order to determine whether a more active approach to surveillance can capture higher rates of AEIs.
연구 유형
관찰
등록 (실제)
11530
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Surrey, 영국, GU2 7XH
- GSK Investigational Site
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6개월 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Registered patients in 9 GP practices in England and who are immunized against seasonal influenza between 1 September 2015 and 30 November 2015
설명
Inclusion Criteria:
- All individuals (aged 6 months and above) who will receive seasonal influenza vaccination in the 9 GP practices between 1 September 2015 and 30 November 2015.
- Pregnant women are also included in this study.
Exclusion Criteria:
• Only registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Study Cohort
Subjects who will receive influenza vaccination between 1 September 2015 and 30 November 2015 in the 9 GP practices from who clinical data routinely collected as part of clinical consultations in primary care will be extracted.
|
Extraction of routinely collected primary care data from nine GP practices and an active surveillance approach in 3 of the 9 GP practices, by using an existing card-based ADR reporting system (MHRA Yellow Card), to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of patient counts of the total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Proportions of total registered patients vaccinated by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Number of patient counts of the total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Proportions of total registered patients vaccinated by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
|
Number of patient counts of the vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Proportions of vaccinated patients with reported endpoints of interest by age strata, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Number of patient counts of the vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Proportions of vaccinated patients with reported endpoints of interest by co-morbidity, reported weekly and cumulatively by brand (also indicating those for whom brand data are unavailable)
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
- Presentation with fever or other febrile illness, - Presentation related to local reaction, - Presentation related to general reaction (fatigue, myalgia, etc.), - All other presentations that could plausibly be related to vaccination.
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Completeness of vaccination data in the computerized medical record system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Completeness of AEI reporting in the computerized medical record system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of vaccination data in the computerized medical record system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of AEI reporting in the computerized medical record system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Completeness of vaccination data in the card-based adverse event reporting system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Completeness of AEI reporting in the card-based adverse event reporting system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of vaccination data in the card-based adverse event reporting system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Timeliness of AEI reporting in the card-based adverse event reporting system.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
|
Incidence rates for the 5 most frequently reported AEs reported alongside those available in the literature from a similar population (vaccinated or general population if vaccinated not available) within the same risk period and stratified by age.
기간: Up to 3 months (between 1 September 2015 and 30 November 2015)
|
Up to 3 months (between 1 September 2015 and 30 November 2015)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 10월 1일
기본 완료 (실제)
2015년 11월 1일
연구 완료 (실제)
2015년 11월 1일
연구 등록 날짜
최초 제출
2015년 9월 18일
QC 기준을 충족하는 최초 제출
2015년 10월 1일
처음 게시됨 (추정)
2015년 10월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 2월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 2월 11일
마지막으로 확인됨
2016년 2월 1일
추가 정보
이 연구와 관련된 용어
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. .