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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
  Purpose

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.


Condition
Influenza
Vaccines Adverse Reaction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Active Surveillance of Adverse Events Following Immunization Among Healthcare Workers Immunized With the Influenza Vaccine

Resource links provided by NLM:


Further study details as provided by PHAC/CIHR Influenza Research Network:

Primary Outcome Measures:
  • 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 ]

Enrollment: 7645
Study Start Date: October 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318876

Locations
Canada, British Columbia
BC Children's and Women's Hospital, Vancouver
Vancouver, British Columbia, Canada
University of British Columbia,
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Canadian Center for Vaccinology, Halifax
Halifax, Nova Scotia, Canada
Canada, Ontario
The Ottawa General Hospital,
Ottawa, Ontario, Canada
Mount Sinai Hospital, Toronto
Toronto, Ontario, Canada
Canada, Quebec
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada, G1V 4V2
Centre Hospitalier et Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
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
  More Information

No publications provided by PHAC/CIHR Influenza Research Network

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gaston De Serres, Epidemiologist at the National Institute of Public Health of Quebec and professor of epidemiology at the University Laval, PHAC/CIHR Influenza Research Network
ClinicalTrials.gov Identifier: NCT01318876     History of Changes
Other Study ID Numbers: pcirn-surveillancehcw-1011
Study First Received: March 18, 2011
Results First Received: July 9, 2012
Last Updated: August 15, 2012
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by PHAC/CIHR Influenza Research Network:
influenza
vaccine safety
adverse events
health care workers

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014