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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


  Baseline Characteristics


  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, 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
  Hide Serious Adverse Events

Time Frame 6 months
Additional Description No text entered.

Reporting Groups
  Description
Health Care Workers From CHUQ Hospitals No text entered.

Serious Adverse Events
    Health Care Workers From CHUQ Hospitals
Total, Serious Adverse Events   
# participants affected / at risk   35/3064 (1.14%) 
Cardiac disorders   
Chronic pericarditis   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Endocrine disorders   
pancreas cancer   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Eye disorders   
Eye problem   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Gastrointestinal disorders   
Gastroenteritis   
# participants affected / at risk   4/3064 (0.13%) 
# events   4 
abdominal problems   
# participants affected / at risk   4/3064 (0.13%) 
# events   4 
General disorders   
severe headaches   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Immune system disorders   
Anaphylactic shock   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Infections and infestations   
Respiratory infection   
# participants affected / at risk   3/3064 (0.10%) 
# events   3 
cutaneous infection   
# participants affected / at risk   2/3064 (0.07%) 
# events   2 
toxic shock syndrome   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Injury, poisoning and procedural complications   
no diagnosis [1]   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Musculoskeletal and connective tissue disorders   
Musculoskeletal problems   
# participants affected / at risk   2/3064 (0.07%) 
# events   2 
Pregnancy, puerperium and perinatal conditions   
gynecologic problems/obstetrical   
# participants affected / at risk   3/3064 (0.10%) 
# events   3 
Psychiatric disorders   
depression   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Reproductive system and breast disorders   
Breast cancer   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
cervix precancerous cells   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
gynecologic problems   
# participants affected / at risk   3/3064 (0.10%) 
# events   3 
Respiratory, thoracic and mediastinal disorders   
lung cancer   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Asthma   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Surgical and medical procedures   
ear surgery   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
Vaso-vasectomy   
# participants affected / at risk   1/3064 (0.03%) 
# events   1 
[1] intermittent pain in the arm.




  Other Adverse Events
  Hide Other Adverse Events

Time Frame 6 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
Health Care Workers From CHUQ Hospitals No text entered.

Other Adverse Events
    Health Care Workers From CHUQ Hospitals
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   383/4984 (7.68%) 
Gastrointestinal disorders   
gastroenteritis   
# participants affected / at risk   73/4984 (1.46%) 
# events   73 
General disorders   
myalgia   
# participants affected / at risk   70/4984 (1.40%) 
# events   70 
Respiratory, thoracic and mediastinal disorders   
respiratory problems   
# participants affected / at risk   201/4984 (4.03%) 
# events   201 
Skin and subcutaneous tissue disorders   
Local reaction   
# participants affected / at risk   39/4984 (0.78%) 
# events   39 



  Limitations and Caveats
  Hide 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 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