Surveillance for Adverse Events Following Pandemic H1N1 Immunization
|ClinicalTrials.gov Identifier: NCT01289418|
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : August 14, 2012
Last Update Posted : August 21, 2012
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 or disease|
|Novel Influenza A/H1N1|
|Study Type :||Observational|
|Actual Enrollment :||6525 participants|
|Official Title:||Short and Long-Term Electronic Surveillance of a Large Number of Healthcare Workers Following Administration of an Adjuvanted Ph1n1 Vaccine|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
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
- 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 ]
- 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 ]
- the Occurrence of Serious Adverse Events (SAE) [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289418
|Principal Investigator:||Gaston De Serres, MD, PhD||Institut National en Santé Publique du Québec|