Surveillance for Adverse Events Following Influenza Immunization

NCT01318876 | Completed Results

• 1 other identifier: pcirn-surveillancehcw-1011
• Study Type: observational
• Target: 7,645
• Locations: 1 country
• Sites: 7

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.

Conditions

Influenza; Vaccines Adverse Reaction

Keywords

influenza; vaccine safety; adverse events; health care workers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (7)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• PHAC/CIHR Influenza Research Network: lead
• GlaxoSmithKline: collaborator
• Institut National en Santé Publique du Québec: collaborator
• Laval University: collaborator
• CHU de Quebec-Universite Laval: collaborator
• Mount Sinai Hospital, Canada: collaborator
• IWK Health Centre: collaborator
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator
• The Ottawa Hospital: collaborator
• University of British Columbia: collaborator

Study Sites (7)

BC Children's and Women's Hospital, Vancouver

Vancouver, British Columbia, Canada

Location

University of British Columbia,

Vancouver, British Columbia, Canada

Location

Canadian Center for Vaccinology, Halifax

Halifax, Nova Scotia, Canada

Location

The Ottawa General Hospital,

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital, Toronto

Toronto, Ontario, Canada

Location

Centre Hospitalier Universitaire de Québec

Québec, Quebec, G1V 4V2, Canada

Location

Centre Hospitalier et Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 22802929 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

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).

Results Point of Contact

• Title: Gaston De Serres
• Organization: Laval University

gaston.deserres@ssss.gouv.qc.ca

418-666-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Epidemiologist at the National Institute of Public Health of Quebec and professor of epidemiology at the University Laval

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 21, 2012
• Results First Posted: August 14, 2012

Record last verified: 2012-08

Locations

CA (7)