Influenza, Vaccines Adverse Reaction
Conditions
Keywords
influenza, vaccine safety, adverse events, health care workers
Brief summary
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.
Interventions
None listed
Sponsors
GlaxoSmithKline
Institut National en Santé Publique du Québec
Laval University
CHU de Quebec-Universite Laval
Mount Sinai Hospital, Canada
IWK Health Centre
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
The Ottawa Hospital
University of British Columbia
PHAC/CIHR Influenza Research Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Care Workers HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study. | 6,269 |
| Total | 6,269 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Day 29 Survey | survey not completed-don't know why | 1,825 |
| Day 8 Survey | email address invalid | 96 |
| Day 8 Survey | survey not completed-don't know why | 1,724 |
Baseline characteristics
| Characteristic | Health Care Workers |
|---|---|
| Age, Categorical <=18 years | NA Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6269 Participants |
| Age Continuous | 41.77 years STANDARD_DEVIATION 11.87 |
| Sex: Female, Male Female | 4639 Participants |
| Sex: Female, Male Male | 1630 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6,269 |
| serious Total, serious adverse events | 6 / 6,269 |
Outcome results
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
Time frame: at day 8 and 29
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCW From All Sites | Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation | 153 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.
Time frame: day 8 and 29
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HCW From All Sites | Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism. | 254 participants |