Trial record 11 of 136 for:    novel influenza a (h1n1)

Surveillance for Adverse Events Following Pandemic H1N1 Immunization

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Institut National en Santé Publique du Québec
Laval University
Centre Hospitalier Universitaire de Québec, CHU de Québec
Queen Elizabeth II Health Sciences Centre
Mount Sinai Hospital, New York
The Ottawa Hospital
Hamilton Health Sciences Corporation
Alberta Children's Hospital
Vancouver General Hospital
Information provided by (Responsible Party):
Gaston De Serres, Laval University
ClinicalTrials.gov Identifier:
NCT01289418
First received: February 2, 2011
Last updated: August 15, 2012
Last verified: August 2012
  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
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

Resource links provided by NLM:


Further study details as provided by PHAC/CIHR Influenza Research Network:

Primary Outcome Measures:
  • 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
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
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.

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289418

Sponsors and Collaborators
PHAC/CIHR Influenza Research Network
GlaxoSmithKline
Institut National en Santé Publique du Québec
Laval University
Centre Hospitalier Universitaire de Québec, CHU de Québec
Queen Elizabeth II Health Sciences Centre
Mount Sinai Hospital, New York
The Ottawa Hospital
Hamilton Health Sciences Corporation
Alberta Children's Hospital
Vancouver General Hospital
Investigators
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 August 20, 2014