An observational study in Novel Influenza A/H1N1, sponsored by PHAC/CIHR Influenza Research Network. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-21.
Sponsored by PHAC/CIHR Influenza Research Network · Observational
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
PHAC/CIHR Influenza Research Network is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The active surveillance was conducted in 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. Healthcare workers immunized in these institutions were offered to participate in a web-based active surveillance of vaccine safety.
Exclusion Criteria:
-
Health care workers from CHUQ hospitals
Health care workers from the Mount Sinai Hospital
Health care workers from the Queen Elizabeth Hospital
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
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
the Occurrence of Serious Adverse Events (SAE)
Time frame: 6 months
| Milestone | Health Care Workers |
|---|---|
| Started | 6525 |
| Completed | 4307 |
| Not completed | 2218 |
| Withdrew: Email address invalid | 283 |
| Withdrew: Participants did not complete the survey | 1935 |
| Milestone | Health Care Workers |
|---|---|
| Started | 6525 |
| Completed | 4057 |
| Not completed | 2468 |
| Withdrew: Email address invalid | 283 |
| Withdrew: Participants did not complete the survey | 2185 |
| participants | 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 | 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 | Health Care Workers From CHUQ Hospitals |
|---|---|
| the Occurrence of Serious Adverse Events (SAE) | 35 |
Collected over 6 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Health Care Workers From CHUQ Hospitals | — | 35/3,064 (1.1%) | 383/4,984 (7.7%) |
| Event | Health Care Workers From CHUQ Hospitals |
|---|---|
| GastroenteritisGastrointestinal disorders | 4/3064 |
| abdominal problemsGastrointestinal disorders | 4/3064 |
| gynecologic problems/obstetricalPregnancy, puerperium and perinatal conditions | 3/3064 |
| gynecologic problemsReproductive system and breast disorders | 3/3064 |
| Respiratory infectionInfections and infestations | 3/3064 |
| cutaneous infectionInfections and infestations | 2/3064 |
| Musculoskeletal problemsMusculoskeletal and connective tissue disorders | 2/3064 |
| Breast cancerReproductive system and breast disorders | 1/3064 |
| lung cancerRespiratory, thoracic and mediastinal disorders | 1/3064 |
| pancreas cancerEndocrine disorders | 1/3064 |
| Event | Health Care Workers From CHUQ Hospitals |
|---|---|
| respiratory problemsRespiratory, thoracic and mediastinal disorders | 201/4984 |
| gastroenteritisGastrointestinal disorders | 73/4984 |
| myalgiaGeneral disorders | 70/4984 |
| Local reactionSkin and subcutaneous tissue disorders | 39/4984 |
| Age Categorical(participants) | Health Care Workers in Quebec | Health Care Workers in Toronto | Health Care Workers in Halifax | Total |
|---|---|---|---|---|
| <=18 years | 0 | NA | NA | 0 |
| Between 18 and 65 years | 3152 | NA | NA | 3152 |
| >=65 years | 1 | NA | NA | 1 |
| Age Continuous(years) | Health Care Workers in Quebec | Health Care Workers in Toronto | Health Care Workers in Halifax | Total |
|---|---|---|---|---|
| Mean | 37.5 ± 11.7 | NA ± NA | NA ± NA | 37.5 ± 11.7 |
| Gender(participants) | Health Care Workers in Quebec | Health Care Workers in Toronto | Health Care Workers in Halifax | Total |
|---|---|---|---|---|
| Female | 2310 | NA | NA | 2310 |
| Male | 841 | NA | NA | 841 |
| Region of Enrollment(participants) | Health Care Workers in Quebec | Health Care Workers in Toronto | Health Care Workers in Halifax | Total |
|---|---|---|---|---|
| Canada | 5183 | 519 | 823 | 6525 |
No study locations are listed for this record.
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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PHAC/CIHR Influenza Research Network