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Surveillance for Adverse Events Following Pandemic H1N1 Immunization

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01289418
First Posted: February 3, 2011
Last Update Posted: August 21, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
GlaxoSmithKline
Institut National en Santé Publique du Québec
Laval University
CHU de Quebec-Universite Laval
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
Results First Submitted: July 9, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Novel Influenza A/H1N1

  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 Health care workers from all hospitals

Participant Flow for 2 periods

Period 1:   Day 8 Survey
    Health Care Workers
STARTED   6525 
COMPLETED   4307 
NOT COMPLETED   2218 
email address invalid                283 
participants did not complete the survey                1935 

Period 2:   Day 29 Survey
    Health Care Workers
STARTED   6525 
COMPLETED   4057 
NOT COMPLETED   2468 
email address invalid                283 
participants did not complete the survey                2185 



  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 in Quebec Health care workers from Quebec
Health Care Workers in Toronto Health Care Workers from Toronto
Health Care Workers in Halifax Health Care Workers from Halifax
Total Total of all reporting groups

Baseline Measures
   Health Care Workers in Quebec   Health Care Workers in Toronto   Health Care Workers in Halifax   Total 
Overall Participants Analyzed 
[Units: Participants]
 5183   519   823   6525 
Age [1] [2] 
[Units: Participants]
       
<=18 years   0   NA [2]   NA [2]   0 
Between 18 and 65 years   3152   NA [2]   NA [2]   3152 
>=65 years   1   NA [2]   NA [2]   1 
[1] Demographic data was collected in only one site (n=3159). Some participants did not complete all the questions. That's why we don't have the age and the gender for all the participants.
[2] demographic data were available only for Quebec
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 37.5  (11.7)   NA [1]   NA [1]   37.5  (11.7) 
[1] demographic data were available only for Quebec
Gender [1] [2] 
[Units: Participants]
       
Female   2310   NA [2]   NA [2]   2310 
Male   841   NA [2]   NA [2]   841 
[1] Demographic data was collected in only one site (n=3159). Some participants did not complete all the questions. That's why we don't have the age and the gender for all the participants.
[2] demographic data were available only for Quebec
Region of Enrollment 
[Units: Participants]
       
Canada   5183   519   823   6525 


  Outcome Measures
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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, 15 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, 15 and 29 ]

3.  Primary:   the Occurrence of Serious Adverse Events (SAE)   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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 52% answered the 3 surveys. We don't know why 48% didn't complete the 3 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).


  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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gaston De Serres, Laval University
ClinicalTrials.gov Identifier: NCT01289418     History of Changes
Other Study ID Numbers: pcirn-surveillancehcw-0910
First Submitted: February 2, 2011
First Posted: February 3, 2011
Results First Submitted: July 9, 2012
Results First Posted: August 14, 2012
Last Update Posted: August 21, 2012