InfluenzaNCT01318876
Surveillance for Adverse Events Following Influenza Immunization
An observational study of Influenza and Vaccines Adverse Reaction, run by PHAC/CIHR Influenza Research Network at 7 sites in Canada.
Trial 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) and with oculorespiratory syndrome in 2001. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Vaccines Adverse Reaction
- How many people
- 7,645 participants
- Where
- 7 sitesCanada
- Study dates
- Oct 2010to Feb 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The active surveillance was conducted in five Canadian hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research-Influenza Research Network (PCIRN): Quebec City, Toronto, Halifax, Vancouver (2 sites), Ottawa and Sherbrooke. Healthcare workers immunized in these institutions were offered to participate in a web-based active surveillance of vaccine safety.
Who may be able to join
- To be a healthcare worker from one of the seven Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research-Influenza Research Network (PCIRN): Quebec City, Toronto, Halifax, Vancouver, Ottawa and Sherbrooke.
- To have been immunized with the influenza vaccine 2010
- To have an email address
- To be 18 years old and older
- To have sign the consent form
Who cannot join
- Pregnant women
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Canadian Center for Vaccinology, Halifax
Halifax, Nova Scotia
The Ottawa General Hospital,
Ottawa, Ontario
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1V 4V2
Centre Hospitalier et Universitaire de Sherbrooke
Sherbrooke, Quebec
Mount Sinai Hospital, Toronto
Toronto, Ontario
BC Children's and Women's Hospital, Vancouver
Vancouver, British Columbia
University of British Columbia,
Vancouver, British Columbia
About this study
Official title: Active Surveillance of Adverse Events Following Immunization Among Healthcare Workers Immunized With the Influenza Vaccine
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) and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the pH1N1, an increase of allergic-like reactions was observed.
Passive surveillance is collecting notifications of adverse events (AE) on the whole population but the sensitivity of this system is not high and its timeliness is not necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators piloted a web-based active surveillance of a large number of health care workers (HCW) vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK, Canada). Because healthcare workers (HCW) constituted a well-defined group with general good health and received the Influenza vaccine in priority, this group of people was well suited for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited in three different sites (5183 were from Quebec). A total of 468 events (local reactions, fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430 HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded to all questionnaires. During this surveillance, the investigators didn't have unexpected findings but this active surveillance of adverse events among healthcare workers would have been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200 vaccinees. For this year the investigators want to expand the surveillance to more sites and more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to increase the response rate to all three surveys in participants.
Read more
The main objective of this project is to estimate in HCW vaccinated against influenza the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.
This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto, Halifax, + another one ) with a total enrollment of >10 000 HCW. This should allow us to detect AE occurring at a rate of ≥ 1 per 500 vaccinees.
- Conditions
- Influenza, Vaccines Adverse Reaction
- Keywords
- influenza, vaccine safety, adverse events, health care workers
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BC Children's and Women's Hospital, Vancouver. | Not described | |
| University of British Columbia, Vancouver. | Not described | |
| Health care workers in Halifax | Not described | |
| Health care workers from CHUQ hospitals | Not described | |
| Health care workers from Toronto | Not described | |
| Centre hospitalier et universitaire de Sherbrooke | Not described | |
| The Ottawa General Hospital, Ottawa | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Experienced a New Health Problem or the Worsening of an Existing Health Condition That Resulted in a Medical Consultation
Measured: at day 8 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.
Measured: day 8 and 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,645 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHAC/CIHR Influenza Research Network
- Sponsor type
- Other government
- Collaborators
- GlaxoSmithKline, Institut National en Santé Publique du Québec, Laval University, CHU de Quebec-Universite Laval, Mount Sinai Hospital, Canada, IWK Health Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, The Ottawa Hospital, University of British Columbia
- Responsible party
- Principal investigator, Gaston De Serres, PHAC/CIHR Influenza Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318876
- Sponsor's protocol ID
- pcirn-surveillancehcw-1011
- Status last verified
- Aug 2012
- First submitted
- 18 Mar 2011
- Last updated
- 21 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
De Serres G, Gariepy MC, Coleman B, Rouleau I, McNeil S, Benoit M, McGeer A, Ambrose A, Needham J, Bergeron C, Grenier C, Sleigh K, Kallos A, Ouakki M, Ouhoummane N, Stiver G, Valiquette L, McCarthy A, Bettinger J; PHAC-CIHR influenza Research Network (PCIRN). Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine. PLoS One. 2012;7(7):e38563. doi: 10.1371/journal.pone.0038563. Epub 2012 Jul 3.
PubMed 22802929
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance of Adverse Events Following Immunization Among Healthcare Workers Immunized With the Influenza Vaccine
- ClinicalTrials.gov ID
- NCT01318876
- Acronym / sponsor ID
- pcirn-surveillancehcw-1011
- Conditions
- Influenza, Vaccines Adverse Reaction
- Keywords
- influenza, vaccine safety, adverse events, health care workers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,645 participants (actual)
- Lead sponsor
- PHAC/CIHR Influenza Research NetworkOther government
- Collaborators
- GlaxoSmithKline, Institut National en Santé Publique du Québec, Laval University, CHU de Quebec-Universite Laval, Mount Sinai Hospital, Canada, IWK Health Centre, Centre de recherche du Centre hospitalier universitaire de Sherbrooke, The Ottawa Hospital, University of British Columbia
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) and with oculorespiratory syndrome in 2001. Last year, with the vaccination against the pH1N1, an increase of allergic-like reactions was observed.
Passive surveillance is collecting notifications of adverse events (AE) on the whole population but the sensitivity of this system is not high and its timeliness is not necessarily optimal. Last year, with the new pandemic Influenza vaccine the investigators piloted a web-based active surveillance of a large number of health care workers (HCW) vaccinated with the new adjuvanted monovalent pH1N1 influenza vaccine (Arepanrix® GSK, Canada). Because healthcare workers (HCW) constituted a well-defined group with general good health and received the Influenza vaccine in priority, this group of people was well suited for monitoring the safety of the influenza vaccine. For this study, 6242 HCW were recruited in three different sites (5183 were from Quebec). A total of 468 events (local reactions, fever, systemic reactions, gastrointestinal and respiratory problems) were reported by 430 HCW. 80% of the HCW recruited completed at least one of the three surveys and 52% responded to all questionnaires. During this surveillance, the investigators didn't have unexpected findings but this active surveillance of adverse events among healthcare workers would have been effective enough to rapidly detect adverse events occurring at a rate ≥ 1 per 200 vaccinees. For this year the investigators want to expand the surveillance to more sites and more participants to be able to detect AE occurring at rates ≥ 1 per 500 vaccinees, and to increase the response rate to all three surveys in participants.
The main objective of this project is to estimate in HCW vaccinated against influenza the frequency of adverse events of sufficient severity to cause work absenteeism or medical consultation.
This year the network will include 5 Canadian hospitals (Quebec City, Vancouver, Toronto, Halifax, + another one ) with a total enrollment of >10 000 HCW. This should allow us to detect AE occurring at a rate of ≥ 1 per 500 vaccinees.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| BC Children's and Women's Hospital, Vancouver. | – | – |
| University of British Columbia, Vancouver. | – | – |
| Health care workers in Halifax | – | – |
| Health care workers from CHUQ hospitals | – | – |
| Health care workers from Toronto | – | – |
| Centre hospitalier et universitaire de Sherbrooke | – | – |
| The Ottawa General Hospital, Ottawa | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The active surveillance was conducted in five Canadian hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research-Influenza Research Network (PCIRN): Quebec City, Toronto, Halifax, Vancouver (2 sites), Ottawa and Sherbrooke. Healthcare workers immunized in these institutions were offered to participate in a web-based active surveillance of vaccine safety.
Key inclusion criteria (5 listed)
- To be a healthcare worker from one of the seven Canadian Hospitals participating in the Public Health Agency of Canada/Canadian Institutes for Health Research-Influenza Research Network (PCIRN): Quebec City, Toronto, Halifax, Vancouver, Ottawa and Sherbrooke.
- To have been immunized with the influenza vaccine 2010
- To have an email address
- To be 18 years old and older
- To have sign the consent form
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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 and 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22802929De Serres G, Gariepy MC, Coleman B, Rouleau I, McNeil S, Benoit M, McGeer A, Ambrose A, Needham J, Bergeron C, Grenier C, Sleigh K, Kallos A, Ouakki M, Ouhoummane N, Stiver G, Valiquette L, McCarthy A, Bettinger J; PHAC-CIHR influenza Research Network (PCIRN). Short and long-term safety of the 2009 AS03-adjuvanted pandemic vaccine. PLoS One. 2012;7(7):e38563. doi: 10.1371/journal.pone.0038563. Epub 2012 Jul 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Vaccines Adverse Reaction, run by PHAC/CIHR Influenza Research Network at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 and 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2012; AzTrials last refreshed its copy on 6 Nov 2026.