Surveillance for Adverse Events Following Influenza Immunization

Study Overview
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Brief Summary
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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.

Official Title
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Active Surveillance of Adverse Events Following Immunization Among Healthcare Workers Immunized With the Influenza Vaccine

Conditions
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Influenza, Vaccines Adverse Reaction

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BC Children's and Women's Hospital, Vancouver.<br> | |
| University of British Columbia, Vancouver.<br> | |
| Health care workers in Halifax<br> | |
| Health care workers from CHUQ hospitals<br> | |
| Health care workers from Toronto<br> | |
| Centre hospitalier et universitaire de Sherbrooke<br> | |
| The Ottawa General Hospital, Ottawa<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation |  | at day 8 and 29 | 
| Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism. |  | day 8 and 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, vaccine safety, adverse events, health care workers