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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Institut National en Santé Publique du Québec | OTHER |
| Laval University | OTHER |
| CHU de Quebec-Universite Laval |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BC Children's and Women's Hospital, Vancouver. | |||
| University of British Columbia, Vancouver. | |||
| Health care workers in Halifax | |||
| Health care workers from CHUQ hospitals | |||
| Health care workers from Toronto | |||
| Centre hospitalier et universitaire de Sherbrooke | |||
| The Ottawa General Hospital, Ottawa |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The active surveillance was conducted in five Canadian hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research-Influenza Research Network (PCIRN): Quebec City, Toronto, Halifax, Vancouver (2 sites), Ottawa and Sherbrooke. Healthcare workers immunized in these institutions were offered to participate in a web-based active surveillance of vaccine safety.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's and Women's Hospital, Vancouver | Vancouver | British Columbia | Canada | |||
| University of British Columbia, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22802929 | Derived | De Serres G, Gariepy MC, Coleman B, Rouleau I, McNeil S, Benoit M, McGeer A, Ambrose A, Needham J, Bergeron C, Grenier C, Sleigh K, Kallos A, Ouakki M, Ouhoummane N, Stiver G, Valiquette L, McCarthy A, Bettinger J; PHAC-CIHR influenza Research Network (PCIRN). Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine. PLoS One. 2012;7(7):e38563. doi: 10.1371/journal.pone.0038563. Epub 2012 Jul 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Health Care Workers |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 8 Survey |
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| |||||||||||||||||||||
| Day 29 Survey |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Health Care Workers | HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation | Posted | Number | participants | at day 8 and 29 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HCW From All Sites |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spontaneous intracranial hypotension | Vascular disorders |
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Only 70% answered the 2 surveys. We don't know why 30% didn't complete the 2 surveys (were they too sick or not motivated).We didn't have a group of comparable unvaccinated individuals (to estimate the risks attributable to the vaccine).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gaston De Serres | Laval University | 418-666-7000 | 274 | gaston.deserres@ssss.gouv.qc.ca |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| OTHER |
| Mount Sinai Hospital, Canada | OTHER |
| IWK Health Centre | OTHER |
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
| The Ottawa Hospital | OTHER |
| University of British Columbia | OTHER |
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| Vancouver |
| British Columbia |
| Canada |
| Canadian Center for Vaccinology, Halifax | Halifax | Nova Scotia | Canada |
| The Ottawa General Hospital, | Ottawa | Ontario | Canada |
| Mount Sinai Hospital, Toronto | Toronto | Ontario | Canada |
| Centre Hospitalier Universitaire de Québec | Québec | Quebec | G1V 4V2 | Canada |
| Centre Hospitalier et Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada |
|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism. | Posted | Number | participants | day 8 and 29 |
|
|
|
| 6 |
| 6,269 |
| 0 |
| 6,269 |
| kidney stone | Renal and urinary disorders |
|
| uterine fibroids | Reproductive system and breast disorders |
|
| anaphylactic shock to peanuts | Immune system disorders |
|
| allergic reaction (received epinephrine) | Immune system disorders |
|
| bilateral pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |