Novel Influenza A/H1N1
Conditions
Keywords
H1N1, vaccine safety, adverse events, health care workers
Brief summary
Influenza vaccines are continuously modified to adjust to the virus antigenic shifts or drifts, and its safety profile may vary. While generally considered safe, influenza vaccines have been associated in the past with increases in cases of Guillain-Barré syndrome (1976) or with oculorespiratory syndrome (2001). The emergence of a novel strain of H1N1 influenza virus (pH1N1) has prompted health departments worldwide to prepare for mass vaccination campaigns with a new H1N1 pandemic vaccine. Following recommendations of the World Health Organization (WHO), Canada immunized its population with a dose-sparing adjuvanted vaccine. While the adjuvant developed by GlaxoSmithKline (GSK) has been administered to over 39 000 people, only a few hundred will have been vaccinated with the H1N1 formulation in clinical trials before the mass campaign was launched. With this small number, adverse events occurring at a rate \< 1% will not be detected by these clinical trials. Considering that most cases of pH1N1 to date have been relatively mild, it will be imperative to rapidly detect adverse events serious enough to reconsider the use of the vaccine. Passive surveillance is collecting notifications of adverse events but the sensitivity of this system is not high and its timeliness is not necessarily optimal. In Canada, healthcare workers (HCW) are among those who were offered the new pandemic vaccine in priority. Because they were offered the vaccine early in the campaign and because they constitute a well-defined group in good general health, this group of people may be well suited for monitoring the safety of the pH1N1 vaccine. The main objective of this project was to estimate in HCW vaccinated against pH1N1 the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation. The active surveillance was done in HCW from 3 sites (Canadian hospitals) participating in the Pandemic Influenza Research Network (PCIRN): (1) Halifax (Nova Scotia), (2) Quebec City (Quebec): 3 hospitals, (3) Toronto
Interventions
None listed
Sponsors
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
PHAC/CIHR Influenza Research Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* To be a health care worker from one of the three Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research- Influenza Research Network (PCIRN): Quebec City, Toronto, and Halifax. * To have been immunized with the pH1N1 vaccine. * To have an email address. * To be 18 years old and older.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation. | at day 8, 15 and 29 |
| Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in Work Absenteeism. | day 8, 15 and 29 |
| the Occurrence of Serious Adverse Events (SAE) | 6 months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Care Workers in Quebec Health care workers from Quebec | 5,183 |
| Health Care Workers in Toronto Health Care Workers from Toronto | 519 |
| Health Care Workers in Halifax Health Care Workers from Halifax | 823 |
| Total | 6,525 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Day 29 Survey | email address invalid | 283 |
| Day 29 Survey | participants did not complete the survey | 2,185 |
| Day 8 Survey | email address invalid | 283 |
| Day 8 Survey | participants did not complete the survey | 1,935 |
Baseline characteristics
| Characteristic | Health Care Workers in Toronto | Health Care Workers in Halifax | Health Care Workers in Quebec | Total |
|---|---|---|---|---|
| Age Categorical <=18 years | NA participants | NA participants | 0 participants | 0 participants |
| Age Categorical >=65 years | NA participants | NA participants | 1 participants | 1 participants |
| Age Categorical Between 18 and 65 years | NA participants | NA participants | 3152 participants | 3152 participants |
| Age Continuous | NA years | NA years | 37.5 years STANDARD_DEVIATION 11.7 | 37.5 years STANDARD_DEVIATION 11.7 |
| Gender Female | NA participants | NA participants | 2310 participants | 2310 participants |
| Gender Male | NA participants | NA participants | 841 participants | 841 participants |
| Region of Enrollment Canada | 519 participants | 823 participants | 5183 participants | 6525 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 383 / 4,984 |
| serious Total, serious adverse events | 35 / 3,064 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Care Workers | 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
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Care Workers | 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
the Occurrence of Serious Adverse Events (SAE)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Health Care Workers | the Occurrence of Serious Adverse Events (SAE) | 35 participants |