Surveillance for Adverse Events Following Influenza 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
Mount Sinai Hospital, Canada
IWK Health Centre
Centre Hospitalier Universitaire de Sherbrooke
The Ottawa Hospital
University of British Columbia
Information provided by (Responsible Party):
Gaston De Serres, PHAC/CIHR Influenza Research Network
ClinicalTrials.gov Identifier:
NCT01318876
First received: March 18, 2011
Last updated: August 15, 2012
Last verified: August 2012
Results First Received: July 9, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Influenza
Vaccines Adverse Reaction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Health Care Workers No text entered.

Participant Flow for 2 periods

Period 1:   Day 8 Survey
    Health Care Workers  
STARTED     7645  
COMPLETED     5825  
NOT COMPLETED     1820  
email address invalid                 96  
survey not completed-don't know why                 1724  

Period 2:   Day 29 Survey
    Health Care Workers  
STARTED     7549 [1]
COMPLETED     5724  
NOT COMPLETED     1825  
survey not completed-don't know why                 1825  
[1] All participants with a valid e-mail, have received the second survey



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Health Care Workers HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study.

Baseline Measures
    Health Care Workers  
Number of Participants  
[units: participants]
  6269  
Age  
[units: participants]
 
<=18 years     NA [1]
Between 18 and 65 years     6269  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.77  ± 11.87  
Gender  
[units: Participants]
 
Female     4639  
Male     1630  
[1] participants under 18 years old were not recruted.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 and 29 ]

2.  Primary:   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 and 29 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Only 70% answered the 2 surveys. We don't know why 30% didn't complete the 2 surveys (were they too sick or not motivated).We didn't have a group of comparable unvaccinated individuals (to estimate the risks attributable to the vaccine).  


Results Point of Contact:  
Name/Title: Gaston De Serres
Organization: Laval University
phone: 418-666-7000 ext 274
e-mail: gaston.deserres@ssss.gouv.qc.ca


No publications provided by PHAC/CIHR Influenza Research Network

Publications automatically indexed to this study:

Responsible Party: Gaston De Serres, PHAC/CIHR Influenza Research Network
ClinicalTrials.gov Identifier: NCT01318876     History of Changes
Other Study ID Numbers: pcirn-surveillancehcw-1011
Study First Received: March 18, 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