Surveillance for Adverse Events Following Pandemic H1N1 Immunization

NCT ID: NCT01289418

Last Updated: 2012-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6525 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-05-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Health care workers in Québec

Health care workers from CHUQ hospitals

No interventions assigned to this group

Health care workers in Toronto

Health care workers from the Mount Sinai Hospital

No interventions assigned to this group

Health care workers in Halifax

Health care workers from the Queen Elizabeth Hospital

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Institut National en Santé Publique du Québec

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: collaborator

Queen Elizabeth II Health Sciences Centre

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, New York

OTHER

Sponsor Role: collaborator

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

Alberta Children's Hospital

OTHER

Sponsor Role: collaborator

Vancouver General Hospital

OTHER

Sponsor Role: collaborator

PHAC/CIHR Influenza Research Network

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gaston De Serres

Epidemiologist at the National Institute of Public Health of Quebec and professor of epidemiology at the University Laval

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaston De Serres, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut National en Santé Publique du Québec

References

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.

Reference Type: DERIVED

PMID: 22802929 (View on PubMed)

Other Identifiers

pcirn-surveillancehcw-0910

Identifier Type: -

Identifier Source: org_study_id