Clinical trial NCT01289418: Surveillance for Adverse Events Following Pandemic H1N1 Immunization
Official title: Short and Long-Term Electronic Surveillance of a Large Number of Healthcare Workers Following Administration of an Adjuvanted Ph1n1 Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Novel Influenza A/H1N1
Keywords: H1N1
vaccine safety
adverse events
health care workers
Lead sponsor: PHAC/CIHR Influenza Research Network
Sponsor class: OTHER_GOV
Collaborators: name: GlaxoSmithKline
name: Institut National en Santé Publique du Québec
name: Laval University
name: CHU de Quebec-Universite Laval
name: Queen Elizabeth II Health Sciences Centre
name: Mount Sinai Hospital, New York
name: The Ottawa Hospital
name: Hamilton Health Sciences Corporation
name: Alberta Children's Hospital
name: Vancouver General Hospital
First posted: 2011-02-03
Enrollment: 6525
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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:

-

Primary outcomes:
measure: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.
timeFrame: at day 8, 15 and 29
measure: Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.
timeFrame: day 8, 15 and 29
measure: the Occurrence of Serious Adverse Events (SAE)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut National en Santé Publique du Québec
name: Gaston De Serres, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.