Surveillance for Adverse Events Following Influenza Immunization

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Institut National en Santé Publique du Québec
Laval University
Centre Hospitalier Universitaire de Québec, CHU de Québec
Mount Sinai Hospital, Canada
IWK Health Centre
Centre Hospitalier Universitaire de Sherbrooke
The Ottawa Hospital
University of British Columbia
Information provided by (Responsible Party):
Gaston De Serres, PHAC/CIHR Influenza Research Network
ClinicalTrials.gov Identifier:
NCT01318876
First received: March 18, 2011
Last updated: August 15, 2012
Last verified: August 2012

March 18, 2011
August 15, 2012
October 2010
February 2011   (final data collection date for primary outcome 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 [ Time Frame: at day 8 and 29 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01318876 on ClinicalTrials.gov Archive Site
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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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.

  • Influenza
  • Vaccines Adverse Reaction
Not Provided
  • 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
De Serres G, Gariépy MC, Coleman B, Rouleau I, McNeil S, Benoît 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7645
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01318876
pcirn-surveillancehcw-1011
No
Gaston De Serres, PHAC/CIHR Influenza Research Network
PHAC/CIHR Influenza Research Network
  • GlaxoSmithKline
  • Institut National en Santé Publique du Québec
  • Laval University
  • Centre Hospitalier Universitaire de Québec, CHU de Québec
  • Mount Sinai Hospital, Canada
  • IWK Health Centre
  • Centre Hospitalier Universitaire de Sherbrooke
  • The Ottawa Hospital
  • University of British Columbia
Not Provided
PHAC/CIHR Influenza Research Network
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP