Surveillance for Adverse Events Following Pandemic H1N1 Immunization
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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) 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
| Condition |
|---|
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Novel Influenza A/H1N1 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Short and Long-Term Electronic Surveillance of a Large Number of Healthcare Workers Following Administration of an Adjuvanted Ph1n1 Vaccine |
- 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, 15 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, 15 and 29 ] [ Designated as safety issue: Yes ]
- the Occurrence of Serious Adverse Events (SAE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 6525 |
| Study Start Date: | October 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Health care workers in Québec
Health care workers from CHUQ hospitals
|
|
Health care workers in Toronto
Health care workers from the Mount Sinai Hospital
|
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Health care workers in Halifax
Health care workers from the Queen Elizabeth Hospital
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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.
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:
-
Contacts and Locations| Principal Investigator: | Gaston De Serres, MD, PhD | Institut National en Santé Publique du Québec |
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, Laval University |
| ClinicalTrials.gov Identifier: | NCT01289418 History of Changes |
| Other Study ID Numbers: | pcirn-surveillancehcw-0910 |
| Study First Received: | February 2, 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:
|
H1N1 vaccine safety adverse events health care workers |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013