Clinical trial NCT01318876: Surveillance for Adverse Events Following Influenza Immunization
Official title: Active Surveillance of Adverse Events Following Immunization Among Healthcare Workers Immunized With the Influenza Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Vaccines Adverse Reaction
Keywords: influenza
vaccine safety
adverse events
health care workers
Lead sponsor: PHAC/CIHR Influenza Research Network
Sponsor class: OTHER_GOV
Collaborators: name: GlaxoSmithKline
name: Institut National en Santé Publique du Québec
name: Laval University
name: CHU de Quebec-Universite Laval
name: Mount Sinai Hospital, Canada
name: IWK Health Centre
name: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
name: The Ottawa Hospital
name: University of British Columbia
First posted: 2011-03-21
Enrollment: 7645
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation
timeFrame: at day 8 and 29
measure: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.
timeFrame: day 8 and 29
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's and Women's Hospital, Vancouver
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia,
state: British Columbia
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology, Halifax
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa General Hospital,
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital, Toronto
state: Ontario
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier et Universitaire de Sherbrooke
state: Quebec
Study officials:
References:
citation: 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.