Trial Outcomes & Findings for Surveillance for Adverse Events Following Pandemic H1N1 Immunization (NCT NCT01289418)

NCT ID: NCT01289418

Last Updated: 2012-08-21

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 6525 participants
• Primary outcome timeframe: at day 8, 15 and 29
• Results posted on: 2012-08-21

Participant Flow

Participant milestones

Measure	Health Care Workers Health care workers from all hospitals
Day 8 Survey STARTED	6525
Day 8 Survey COMPLETED	4307
Day 8 Survey NOT COMPLETED	2218
Day 29 Survey STARTED	6525
Day 29 Survey COMPLETED	4057
Day 29 Survey NOT COMPLETED	2468

Reasons for withdrawal

Measure	Health Care Workers Health care workers from all hospitals
Day 8 Survey email address invalid	283
Day 8 Survey participants did not complete the survey	1935
Day 29 Survey email address invalid	283
Day 29 Survey participants did not complete the survey	2185

Baseline Characteristics

Surveillance for Adverse Events Following Pandemic H1N1 Immunization

Baseline characteristics by cohort

Measure	Health Care Workers in Quebec n=5183 Participants Health care workers from Quebec	Health Care Workers in Toronto n=519 Participants Health Care Workers from Toronto	Health Care Workers in Halifax n=823 Participants Health Care Workers from Halifax	Total n=6525 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	0 participants n=4 Participants
Age Categorical Between 18 and 65 years	3152 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	3152 participants n=4 Participants
Age Categorical >=65 years	1 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	1 participants n=4 Participants
Age Continuous	37.5 years STANDARD_DEVIATION 11.7 • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	NA years STANDARD_DEVIATION NA • n=5 Participants	37.5 years STANDARD_DEVIATION 11.7 • n=4 Participants
Gender Female	2310 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	2310 participants n=4 Participants
Gender Male	841 participants n=5 Participants	NA participants n=7 Participants	NA participants n=5 Participants	841 participants n=4 Participants
Region of Enrollment Canada	5183 participants n=5 Participants	519 participants n=7 Participants	823 participants n=5 Participants	6525 participants n=4 Participants

PRIMARY outcome

Timeframe: at day 8, 15 and 29

Outcome measures

Measure	Health Care Workers n=6242 Participants Health care workers with a valid e-mail address
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation.	234 participants

PRIMARY outcome

Timeframe: day 8, 15 and 29

Outcome measures

Measure	Health Care Workers n=6242 Participants Health care workers with a valid e-mail address
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism.	374 participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Health Care Workers n=3064 Participants Health care workers with a valid e-mail address
the Occurrence of Serious Adverse Events (SAE)	35 participants

Adverse Events

Health Care Workers From CHUQ Hospitals

Serious events: 35 serious events

Other events: 383 other events

Deaths: 0 deaths

Serious adverse events

Measure	Health Care Workers From CHUQ Hospitals n=4984 participants at risk；n=3064 participants at risk
Reproductive system and breast disorders Breast cancer	0.03% 1/3064 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders lung cancer	0.03% 1/3064 • Number of events 1 • 6 months
Endocrine disorders pancreas cancer	0.03% 1/3064 • Number of events 1 • 6 months
Reproductive system and breast disorders cervix precancerous cells	0.03% 1/3064 • Number of events 1 • 6 months
Pregnancy, puerperium and perinatal conditions gynecologic problems/obstetrical	0.10% 3/3064 • Number of events 3 • 6 months
Reproductive system and breast disorders gynecologic problems	0.10% 3/3064 • Number of events 3 • 6 months
Infections and infestations Respiratory infection	0.10% 3/3064 • Number of events 3 • 6 months
Gastrointestinal disorders Gastroenteritis	0.13% 4/3064 • Number of events 4 • 6 months
Infections and infestations cutaneous infection	0.07% 2/3064 • Number of events 2 • 6 months
Infections and infestations toxic shock syndrome	0.03% 1/3064 • Number of events 1 • 6 months
Gastrointestinal disorders abdominal problems	0.13% 4/3064 • Number of events 4 • 6 months
Musculoskeletal and connective tissue disorders Musculoskeletal problems	0.07% 2/3064 • Number of events 2 • 6 months
Psychiatric disorders depression	0.03% 1/3064 • Number of events 1 • 6 months
Immune system disorders Anaphylactic shock	0.03% 1/3064 • Number of events 1 • 6 months
Cardiac disorders Chronic pericarditis	0.03% 1/3064 • Number of events 1 • 6 months
Eye disorders Eye problem	0.03% 1/3064 • Number of events 1 • 6 months
Surgical and medical procedures ear surgery	0.03% 1/3064 • Number of events 1 • 6 months
General disorders severe headaches	0.03% 1/3064 • Number of events 1 • 6 months
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 1/3064 • Number of events 1 • 6 months
Surgical and medical procedures Vaso-vasectomy	0.03% 1/3064 • Number of events 1 • 6 months
Injury, poisoning and procedural complications no diagnosis	0.03% 1/3064 • Number of events 1 • 6 months

Other adverse events

Measure	Health Care Workers From CHUQ Hospitals n=4984 participants at risk；n=3064 participants at risk
Skin and subcutaneous tissue disorders Local reaction	0.78% 39/4984 • Number of events 39 • 6 months
General disorders myalgia	1.4% 70/4984 • Number of events 70 • 6 months
Respiratory, thoracic and mediastinal disorders respiratory problems	4.0% 201/4984 • Number of events 201 • 6 months
Gastrointestinal disorders gastroenteritis	1.5% 73/4984 • Number of events 73 • 6 months

Additional Information

Gaston De Serres

Laval University

Phone: 418-666-7000

Email: gaston.deserres@ssss.gouv.qc.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place