Surveillance for Adverse Events Following Influenza Immunization
Active Surveillance of Adverse Events Following Immunization Among Healthcare Workers Immunized With the Influenza Vaccine
Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the pH1N1, an increase of allergic-like reactions was observed.
Passive surveillance is collecting notifications of adverse events (AE) on the whole population but the sensitivity of this system is not high and its timeliness is not necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators piloted a web-based active surveillance of a large number of health care workers (HCW) vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK, Canada). Because healthcare workers (HCW) constituted a well-defined group with general good health and received the Influenza vaccine in priority, this group of people was well suited for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited in three different sites (5183 were from Quebec). A total of 468 events (local reactions, fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430 HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded to all questionnaires. During this surveillance, the investigators didn't have unexpected findings but this active surveillance of adverse events among healthcare workers would have been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200 vaccinees. For this year the investigators want to expand the surveillance to more sites and more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to increase the response rate to all three surveys in participants.
The main objective of this project is to estimate in HCW vaccinated against influenza the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.
This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto, Halifax, + another one ) with a total enrollment of >10 000 HCW. This should allow us to detect AE occurring at a rate of ≥ 1 per 500 vaccinees.
研究概览
地位
研究类型
注册 (实际的)
联系人和位置
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大
- BC Children's and Women's Hospital, Vancouver
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Vancouver、British Columbia、加拿大
- University of British Columbia,
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Nova Scotia
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Halifax、Nova Scotia、加拿大
- Canadian Center for Vaccinology, Halifax
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Ontario
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Ottawa、Ontario、加拿大
- The Ottawa General Hospital,
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Toronto、Ontario、加拿大
- Mount Sinai Hospital, Toronto
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Quebec
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Québec、Quebec、加拿大、G1V 4V2
- Centre Hospitalier Universitaire de Quebec
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Sherbrooke、Quebec、加拿大
- Centre Hospitalier et Universitaire de Sherbrooke
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- To be a healthcare worker from one of the seven Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research-Influenza Research Network (PCIRN): Quebec City, Toronto, Halifax, Vancouver, Ottawa and Sherbrooke.
- To have been immunized with the influenza vaccine 2010
- To have an email address
- To be 18 years old and older
- To have sign the consent form
Exclusion Criteria:
- Pregnant women
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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BC Children's and Women's Hospital, Vancouver.
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University of British Columbia, Vancouver.
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Health care workers in Halifax
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Health care workers from CHUQ hospitals
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Health care workers from Toronto
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Centre hospitalier et universitaire de Sherbrooke
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The Ottawa General Hospital, Ottawa
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation
大体时间:at day 8 and 29
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at day 8 and 29
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Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.
大体时间:day 8 and 29
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day 8 and 29
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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