Surveillance for Adverse Events Following Pandemic H1N1 Immunization

NCT01289418 | Completed Results

• 1 other identifier: pcirn-surveillancehcw-0910
• Study Type: observational
• Target: 6,525
• Locations: 0 countries
• Sites: N/A

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) or with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine. While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000 people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical trials before the mass campaign was launched. With this small number, adverse events occurring at a rate \< 1% will not be detected by these clinical trials. Considering that most cases of pH1N1 to date have been relatively mild, it will be imperative to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive surveillance is collecting notifications of adverse events but the sensitivity of this system is not high and its timeliness is not necessarily optimal. In Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine in priority. Because they were offered the vaccine early in the campaign and because they constitute a well-defined group in good general health, this group of people may be well suited for monitoring the safety of the pH1N1 vaccine. The main objective of this project was to estimate in HCW vaccinated against pH1N1 the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation. The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City (Quebec): 3 hospitals, (3) Toronto

Conditions

Novel Influenza A/H1N1

Keywords

H1N1; vaccine safety; adverse events; health care workers

Outcome Measures

Primary Outcomes (3)

• 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, 15 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, 15 and 29

• the Occurrence of Serious Adverse Events (SAE)

  6 months

Study Arms (3)

Health care workers in Québec

Health care workers from CHUQ hospitals

Health care workers in Toronto

Health care workers from the Mount Sinai Hospital

Health care workers in Halifax

Health care workers from the Queen Elizabeth Hospital

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 three Canadian hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax. 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 health care worker from one of the three Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax.
• To have been immunized with the pH1N1 vaccine.
• To have an email address.
• To be 18 years old and older.

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
• Queen Elizabeth II Health Sciences Centre: collaborator
• Mount Sinai Hospital, New York: collaborator
• The Ottawa Hospital: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Alberta Children's Hospital: collaborator
• Vancouver General Hospital: collaborator

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

Limitations and Caveats

Only 52% answered the 3 surveys. We don't know why 48% didn't complete the 3 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

Study Officials

• Gaston De Serres, MD, PhD

  Institut National en Santé Publique du Québec

  PRINCIPAL INVESTIGATOR

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: February 2, 2011
• First Posted: February 3, 2011
• Study Start: October 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 21, 2012
• Results First Posted: August 14, 2012

Record last verified: 2012-08