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Surveillance for Adverse Events Following Pandemic H1N1 Immunization

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ClinicalTrials.gov Identifier: NCT01289418
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : August 14, 2012
Last Update Posted : August 21, 2012
Sponsor:
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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Novel Influenza A/H1N1
Enrollment 6525
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Health Care Workers
Hide Arm/Group Description Health care workers from all hospitals
Period Title: Day 8 Survey
Started 6525
Completed 4307
Not Completed 2218
Reason Not Completed
email address invalid             283
participants did not complete the survey             1935
Period Title: Day 29 Survey
Started 6525
Completed 4057
Not Completed 2468
Reason Not Completed
email address invalid             283
participants did not complete the survey             2185
Arm/Group Title Health Care Workers in Quebec Health Care Workers in Toronto Health Care Workers in Halifax Total
Hide Arm/Group Description Health care workers from Quebec Health Care Workers from Toronto Health Care Workers from Halifax Total of all reporting groups
Overall Number of Baseline Participants 5183 519 823 6525
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5183 participants 519 participants 823 participants 6525 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]
Measure Description: 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 Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5183 participants 519 participants 823 participants 6525 participants
37.5  (11.7) NA [1]   (NA) NA [1]   (NA) 37.5  (11.7)
[1]
demographic data were available only for Quebec
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5183 participants 519 participants 823 participants 6525 participants
Female 2310 NA [2]  NA [2]  2310
Male 841 NA [2]  NA [2]  841
[1]
Measure Description: 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  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 5183 participants 519 participants 823 participants 6525 participants
5183 519 823 6525
1.Primary Outcome
Title Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.
Hide Description [Not Specified]
Time Frame at day 8, 15 and 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Health Care Workers
Hide Arm/Group Description:
Health care workers with a valid e-mail address
Overall Number of Participants Analyzed 6242
Measure Type: Number
Unit of Measure: participants
234
2.Primary Outcome
Title Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.
Hide Description [Not Specified]
Time Frame day 8, 15 and 29
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Health Care Workers
Hide Arm/Group Description:
Health care workers with a valid email address
Overall Number of Participants Analyzed 6242
Measure Type: Number
Unit of Measure: participants
374
3.Primary Outcome
Title the Occurrence of Serious Adverse Events (SAE)
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Health Care Workers From CHUQ Hospitals
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 3064
Measure Type: Number
Unit of Measure: participants
35
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Health Care Workers From CHUQ Hospitals
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Health Care Workers From CHUQ Hospitals
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Health Care Workers From CHUQ Hospitals
Affected / at Risk (%) # Events
Total   35/3064 (1.14%)    
Cardiac disorders   
Chronic pericarditis  1/3064 (0.03%)  1
Endocrine disorders   
pancreas cancer  1/3064 (0.03%)  1
Eye disorders   
Eye problem  1/3064 (0.03%)  1
Gastrointestinal disorders   
Gastroenteritis  4/3064 (0.13%)  4
abdominal problems  4/3064 (0.13%)  4
General disorders   
severe headaches  1/3064 (0.03%)  1
Immune system disorders   
Anaphylactic shock  1/3064 (0.03%)  1
Infections and infestations   
Respiratory infection  3/3064 (0.10%)  3
cutaneous infection  2/3064 (0.07%)  2
toxic shock syndrome  1/3064 (0.03%)  1
Injury, poisoning and procedural complications   
no diagnosis [1]  1/3064 (0.03%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal problems  2/3064 (0.07%)  2
Pregnancy, puerperium and perinatal conditions   
gynecologic problems/obstetrical  3/3064 (0.10%)  3
Psychiatric disorders   
depression  1/3064 (0.03%)  1
Reproductive system and breast disorders   
Breast cancer  1/3064 (0.03%)  1
cervix precancerous cells  1/3064 (0.03%)  1
gynecologic problems  3/3064 (0.10%)  3
Respiratory, thoracic and mediastinal disorders   
lung cancer  1/3064 (0.03%)  1
Asthma  1/3064 (0.03%)  1
Surgical and medical procedures   
ear surgery  1/3064 (0.03%)  1
Vaso-vasectomy  1/3064 (0.03%)  1
[1]
intermittent pain in the arm.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Health Care Workers From CHUQ Hospitals
Affected / at Risk (%) # Events
Total   383/4984 (7.68%)    
Gastrointestinal disorders   
gastroenteritis  73/4984 (1.46%)  73
General disorders   
myalgia  70/4984 (1.40%)  70
Respiratory, thoracic and mediastinal disorders   
respiratory problems  201/4984 (4.03%)  201
Skin and subcutaneous tissue disorders   
Local reaction  39/4984 (0.78%)  39
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).
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
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