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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

  Participant Flow

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

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

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 ]

Measure Type Primary
Measure 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.
Measure Description No text entered.
Time Frame at day 8, 15 and 29  

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 Health care workers with a valid e-mail address

Measured Values
   Health Care Workers 
Participants Analyzed   6242 
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation. 
[Units: Participants]
 234 

No statistical analysis provided for Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.



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 ]

Measure Type Primary
Measure Title Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.
Measure Description No text entered.
Time Frame day 8, 15 and 29  

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 Health care workers with a valid email address

Measured Values
   Health Care Workers 
Participants Analyzed   6242 
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism. 
[Units: Participants]
 374 

No statistical analysis provided for Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.



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

Measure Type Primary
Measure Title the Occurrence of Serious Adverse Events (SAE)
Measure Description No text entered.
Time Frame 6 months  

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 From CHUQ Hospitals No text entered.

Measured Values
   Health Care Workers From CHUQ Hospitals 
Participants Analyzed   3064 
the Occurrence of Serious Adverse Events (SAE) 
[Units: Participants]
 35 

No statistical analysis provided for the Occurrence of Serious Adverse Events (SAE)




  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

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

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