InfluenzaSOS-VE01NCT01517191
Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults
An observational study of Influenza, run by Dalhousie University at 14 sites in Canada.
Trial summary
This surveillance study will include all consenting adults hospitalized with influenza (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to assess vaccine effectiveness in each group. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Influenza
- How many people
- 4,197 participants
- Where
- 14 sitesCanada
- Study dates
- Nov 2011to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This observational study is open to adults admitted to hospital with test postitive influenza or with an influenza like illness who test negative.
Who may be able to join
- Adult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following admitting diagnoses will be eligible for screening:
- pneumonia
- acute exacerbation of chronic obstructive pulmonary disease (AECOPD) or asthma
- unexplained sepsis
- Any other respiratory infection or diagnosis Or any respiratory or influenza-like symptom )(eg dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness, CHF)
Who cannot join
- Patients whose reason for admission was clearly unrelated to the presence of influenza (for example, patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory,, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding) Unless being enrolled as a nosocomial influenza case
- Patients whose onset of symptoms was prior to or within 72 hours of hospital admission but who were not tested for influenza within 7 days of hospital admission. These should be captured on the screening form as screen failures.
- No children in care will be enrolled in the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Canada14 sites
William Osler Health Center
Brampton, Ontario, L6R 3J7
Advanced Medical Research Institue of Canada
Greater Sudbury, Ontario, P3E 5J1
QEII Health Science Centre
Halifax, Nova Scotia, B3K 6R8
McMaster
Hamilton, Ontario
The Moncton Hospital
Moncton, New Brunswick, E1C 6Z8
MUCH
Montreal, Quebec
Ottawa General
Ottawa, Ontario
CHUl/CHUQ
Québec, Canada
Saint John Regional Hospital
Saint John, New Brunswick
CHUS
Sherbrooke, Quebec
North York General Hospital
Toronto, Ontario, M2K 1E1
Toronto East General Hospital
Toronto, Ontario, M4C 3E7
Mount Sinai
Toronto, Ontario
Vancouver General
Vancouver, British Columbia
About this study
This surveillance study will include all consenting adults hospitalized with influenza (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to assess vaccine effectiveness in each group. Both groups will be followed throughout their hospitalization and for 30 days post discharge to monitor severity of illness and outcomes following their illness.
Read the detailed description
The Canadian Immunization Research Network(CIRN) is a collaborative research network which brings together over 100 investigators in over 40 institutions to evaluate all factors relevant to the introduction of a pandemic influenza vaccine in Canada. The Serious Outcomes Surveillance (SOS) Network within CIRN was established in 2009 to plan for evaluation of influenza vaccine safety and effectiveness. Vaccine effectiveness studies are critical in assessing vaccine effectiveness under real world conditions and in assessing vaccine effectiveness in the prevention of severe outcomes. Establishing the methodology and infrastructure for real-time field assessment of vaccine effectiveness is crucial to inform policy recommendations for the optimal use of resources, including vaccines.
This study will include all consenting adult patients hospitalized at one of the SOS Network hospitals during influenza season who test positive for influenza (cases). In addition two influenza negative controls will be matched to each case to measure differences in vaccine effectiveness. Specific study aims are:
- To determine the effectiveness of trivalent influenza vaccination (TIV in general, and GSK TIV in particular) in preventing influenza-associated hospitalization in adults ≥ 65 years,
- To determine the effectiveness of influenza vaccination in preventing influenza-associated death in adults ≥ 65 years
- To determine the effectiveness of influenza vaccination in preventing influenza-associated hospitalization and death in adults < 65 years
- To characterize the burden of disease, clinical outcomes, and resource utilization associated with influenza A and influenza B lineages
- To examine clinical and immunologic factors impacting on severity of disease and influenza vaccine effectiveness in adults
- Conditions
- Influenza
- Keywords
- Influenza, Respiratory Infection
- Medical subject headings
- Influenza, Human, Respiratory Tract Infections
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 |
|---|---|---|
| Influenza Positive Case | Influenza cases are hospitalized adults who have tested positive for influenza. | |
| Influenza Negative Control | Control Controls are hospitalized adults who have tested negative for influenza. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the burden of influenza disease and influenza vaccine effectiveness.
Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 65 years of age.
Measured: 1 Year
Secondary outcomes (1)
Estimate the burden of influenza disease and influenza vaccine effectiveness.
Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 16 years of age
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), Canadian Institutes of Health Research (CIHR), GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Shelly A McNeil, MD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517191
- Sponsor's protocol ID
- SOS-VE01
- Acronym
- SOS-VE01
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2012
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Pott H, LeBlanc JJ, ElSherif M, Hatchette TF, Andrew MK, McNeil SA. Human Metapneumovirus Epidemiology Among Middle-aged and Older Adults Hospitalized With Acute Respiratory Infection. J Infect Dis. 2025 Jul 16;232(Supplement_1):S69-S77. doi: 10.1093/infdis/jiaf083.
PubMed 40668096Pott H, Andrew MK, Shaffelburg Z, Nichols MK, Ye L, ElSherif M, Hatchette TF, LeBlanc JJ, Ambrose A, Boivin G, Bowie W, Johnstone J, Katz K, Lagace-Wiens P, Loeb M, McCarthy A, McGeer A, Poirier A, Powis J, Richardson D, Semret M, Smith S, Smyth D, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA. Oseltamivir Reduces 30-Day Mortality in Older Adults With Influenza: A Pooled Analysis From the 2012-2019 Serious Outcomes Surveillance Network of the Canadian Immunization Research Network. Open Forum Infect Dis. 2025 Feb 3;12(2):ofaf058. doi: 10.1093/ofid/ofaf058. eCollection 2025 Feb.
PubMed 39968306Shoukat A, Bawden CE, Rost G, LeBlanc JJ, Galvani AP, Langley JM, Moghadas SM. Impact and cost-effectiveness analyses of vaccination for prevention of respiratory syncytial virus disease among older adults in Ontario: A Canadian Immunization Research Network (CIRN) study. Vaccine. 2024 Mar 7;42(7):1768-1776. doi: 10.1016/j.vaccine.2024.02.041. Epub 2024 Feb 16.
PubMed 38368226Mulpuru S, Andrew MK, Ye L, Hatchette T, LeBlanc J, El-Sherif M, MacKinnon-Cameron D, Aaron SD, Alvarez GG, Forster AJ, Ambrose A, McNeil SA; Serious Outcomes Surveillance and Canadian Immunization Research Network (CIRN) Investigators. Impact of respiratory viral infections on mortality and critical illness among hospitalized patients with chronic obstructive pulmonary disease. Influenza Other Respir Viruses. 2022 Nov;16(6):1172-1182. doi: 10.1111/irv.13050. Epub 2022 Sep 7.
PubMed 36069141LeBlanc JJ, ElSherif M, Mulpuru S, Warhuus M, Ambrose A, Andrew M, Boivin G, Bowie W, Chit A, Dos Santos G, Green K, Halperin SA, Hatchette TF, Ibarguchi B, Johnstone J, Katz K, Langley JM, Lagace-Wiens P, Loeb M, Lund A, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA. Validation of the Seegene RV15 multiplex PCR for the detection of influenza A subtypes and influenza B lineages during national influenza surveillance in hospitalized adults. J Med Microbiol. 2020 Feb;69(2):256-264. doi: 10.1099/jmm.0.001032. Epub 2019 Jun 28.
PubMed 31264957Mulpuru S, Li L, Ye L, Hatchette T, Andrew MK, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). Effectiveness of Influenza Vaccination on Hospitalizations and Risk Factors for Severe Outcomes in Hospitalized Patients With COPD. Chest. 2019 Jan;155(1):69-78. doi: 10.1016/j.chest.2018.10.044.
PubMed 30616737Nichols MK, Andrew MK, Ye L, Hatchette TF, Ambrose A, Boivin G, Bowie W, Dos Santos G, Elsherif M, Green K, Haguinet F, Katz K, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Powis J, Richardson D, Semret M, Sharma R, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). The Impact of Prior Season Vaccination on Subsequent Influenza Vaccine Effectiveness to Prevent Influenza-related Hospitalizations Over 4 Influenza Seasons in Canada. Clin Infect Dis. 2019 Aug 30;69(6):970-979. doi: 10.1093/cid/ciy1009.
PubMed 30508064Nichols MK, Andrew MK, Hatchette TF, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Lagace-Wiens P, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Schuind A, Semret M, Shinde V, Smith S, Smyth D, Stiver G, Taylor G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Serious Outcomes Surveillance Network of the Canadian Immunization Research Network (CIRN), the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness to prevent influenza-related hospitalizations and serious outcomes in Canadian adults over the 2011/12 through 2013/14 influenza seasons: A pooled analysis from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS Network). Vaccine. 2018 Apr 12;36(16):2166-2175. doi: 10.1016/j.vaccine.2018.02.093. Epub 2018 Mar 13.
PubMed 29548608Andrew MK, Shinde V, Hatchette T, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney J, McGeer A, Nichols MK, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Serious Outcomes Surveillance Network and the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness against influenza-related hospitalization during a season with mixed outbreaks of four influenza viruses: a test-negative case-control study in adults in Canada. BMC Infect Dis. 2017 Dec 29;17(1):805. doi: 10.1186/s12879-017-2905-8.
PubMed 29284435Andrew MK, Shinde V, Ye L, Hatchette T, Haguinet F, Dos Santos G, McElhaney JE, Ambrose A, Boivin G, Bowie W, Chit A, ElSherif M, Green K, Halperin S, Ibarguchi B, Johnstone J, Katz K, Langley J, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McGeer A, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance Network of the Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) and the Toronto Invasive Bacterial Diseases Network (TIBDN). The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People. J Infect Dis. 2017 Aug 15;216(4):405-414. doi: 10.1093/infdis/jix282.
PubMed 28931244
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults
- ClinicalTrials.gov ID
- NCT01517191
- Acronym / sponsor ID
- SOS-VE01 / SOS-VE01
- Conditions
- Influenza
- Keywords
- Influenza, Respiratory Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,197 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Public Health Agency of Canada (PHAC), Canadian Institutes of Health Research (CIHR), GlaxoSmithKline
- Study start
- Nov 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This surveillance study will include all consenting adults hospitalized with influenza (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to assess vaccine effectiveness in each group. Both groups will be followed throughout their hospitalization and for 30 days post discharge to monitor severity of illness and outcomes following their illness.
Detailed description
The Canadian Immunization Research Network(CIRN) is a collaborative research network which brings together over 100 investigators in over 40 institutions to evaluate all factors relevant to the introduction of a pandemic influenza vaccine in Canada. The Serious Outcomes Surveillance (SOS) Network within CIRN was established in 2009 to plan for evaluation of influenza vaccine safety and effectiveness. Vaccine effectiveness studies are critical in assessing vaccine effectiveness under real world conditions and in assessing vaccine effectiveness in the prevention of severe outcomes. Establishing the methodology and infrastructure for real-time field assessment of vaccine effectiveness is crucial to inform policy recommendations for the optimal use of resources, including vaccines.
This study will include all consenting adult patients hospitalized at one of the SOS Network hospitals during influenza season who test positive for influenza (cases). In addition two influenza negative controls will be matched to each case to measure differences in vaccine effectiveness. Specific study aims are:
- To determine the effectiveness of trivalent influenza vaccination (TIV in general, and GSK TIV in particular) in preventing influenza-associated hospitalization in adults ≥ 65 years,
- To determine the effectiveness of influenza vaccination in preventing influenza-associated death in adults ≥ 65 years
- To determine the effectiveness of influenza vaccination in preventing influenza-associated hospitalization and death in adults < 65 years
- To characterize the burden of disease, clinical outcomes, and resource utilization associated with influenza A and influenza B lineages
- To examine clinical and immunologic factors impacting on severity of disease and influenza vaccine effectiveness in adults
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Positive Case | – | –Influenza cases are hospitalized adults who have tested positive for influenza. |
| Influenza Negative Control | – | –Control Controls are hospitalized adults who have tested negative for influenza. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This observational study is open to adults admitted to hospital with test postitive influenza or with an influenza like illness who test negative.
Key inclusion criteria (5 listed)
- Adult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following admitting diagnoses will be eligible for screening:
- pneumonia
- acute exacerbation of chronic obstructive pulmonary disease (AECOPD) or asthma
- unexplained sepsis
- Any other respiratory infection or diagnosis Or any respiratory or influenza-like symptom )(eg dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness, CHF)
Key exclusion criteria (3 listed)
- Patients whose reason for admission was clearly unrelated to the presence of influenza (for example, patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory,, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding) Unless being enrolled as a nosocomial influenza case
- Patients whose onset of symptoms was prior to or within 72 hours of hospital admission but who were not tested for influenza within 7 days of hospital admission. These should be captured on the screening form as screen failures.
- No children in care will be enrolled in the study
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
Estimate the burden of influenza disease and influenza vaccine effectiveness.
Time frame: 1 Year
Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 65 years of age.
1 secondary outcome
Estimate the burden of influenza disease and influenza vaccine effectiveness.
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 40668096Pott H, LeBlanc JJ, ElSherif M, Hatchette TF, Andrew MK, McNeil SA. Human Metapneumovirus Epidemiology Among Middle-aged and Older Adults Hospitalized With Acute Respiratory Infection. J Infect Dis. 2025 Jul 16;232(Supplement_1):S69-S77. doi: 10.1093/infdis/jiaf083.
- Derived from this study: PubMed 39968306Pott H, Andrew MK, Shaffelburg Z, Nichols MK, Ye L, ElSherif M, Hatchette TF, LeBlanc JJ, Ambrose A, Boivin G, Bowie W, Johnstone J, Katz K, Lagace-Wiens P, Loeb M, McCarthy A, McGeer A, Poirier A, Powis J, Richardson D, Semret M, Smith S, Smyth D, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA. Oseltamivir Reduces 30-Day Mortality in Older Adults With Influenza: A Pooled Analysis From the 2012-2019 Serious Outcomes Surveillance Network of the Canadian Immunization Research Network. Open Forum Infect Dis. 2025 Feb 3;12(2):ofaf058. doi: 10.1093/ofid/ofaf058. eCollection 2025 Feb.
- Derived from this study: PubMed 38368226Shoukat A, Bawden CE, Rost G, LeBlanc JJ, Galvani AP, Langley JM, Moghadas SM. Impact and cost-effectiveness analyses of vaccination for prevention of respiratory syncytial virus disease among older adults in Ontario: A Canadian Immunization Research Network (CIRN) study. Vaccine. 2024 Mar 7;42(7):1768-1776. doi: 10.1016/j.vaccine.2024.02.041. Epub 2024 Feb 16.
- Derived from this study: PubMed 36069141Mulpuru S, Andrew MK, Ye L, Hatchette T, LeBlanc J, El-Sherif M, MacKinnon-Cameron D, Aaron SD, Alvarez GG, Forster AJ, Ambrose A, McNeil SA; Serious Outcomes Surveillance and Canadian Immunization Research Network (CIRN) Investigators. Impact of respiratory viral infections on mortality and critical illness among hospitalized patients with chronic obstructive pulmonary disease. Influenza Other Respir Viruses. 2022 Nov;16(6):1172-1182. doi: 10.1111/irv.13050. Epub 2022 Sep 7.
- Derived from this study: PubMed 31264957LeBlanc JJ, ElSherif M, Mulpuru S, Warhuus M, Ambrose A, Andrew M, Boivin G, Bowie W, Chit A, Dos Santos G, Green K, Halperin SA, Hatchette TF, Ibarguchi B, Johnstone J, Katz K, Langley JM, Lagace-Wiens P, Loeb M, Lund A, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA. Validation of the Seegene RV15 multiplex PCR for the detection of influenza A subtypes and influenza B lineages during national influenza surveillance in hospitalized adults. J Med Microbiol. 2020 Feb;69(2):256-264. doi: 10.1099/jmm.0.001032. Epub 2019 Jun 28.
- Derived from this study: PubMed 30616737Mulpuru S, Li L, Ye L, Hatchette T, Andrew MK, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). Effectiveness of Influenza Vaccination on Hospitalizations and Risk Factors for Severe Outcomes in Hospitalized Patients With COPD. Chest. 2019 Jan;155(1):69-78. doi: 10.1016/j.chest.2018.10.044.
- Derived from this study: PubMed 30508064Nichols MK, Andrew MK, Ye L, Hatchette TF, Ambrose A, Boivin G, Bowie W, Dos Santos G, Elsherif M, Green K, Haguinet F, Katz K, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Powis J, Richardson D, Semret M, Sharma R, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). The Impact of Prior Season Vaccination on Subsequent Influenza Vaccine Effectiveness to Prevent Influenza-related Hospitalizations Over 4 Influenza Seasons in Canada. Clin Infect Dis. 2019 Aug 30;69(6):970-979. doi: 10.1093/cid/ciy1009.
- Derived from this study: PubMed 29548608Nichols MK, Andrew MK, Hatchette TF, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Lagace-Wiens P, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Schuind A, Semret M, Shinde V, Smith S, Smyth D, Stiver G, Taylor G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Serious Outcomes Surveillance Network of the Canadian Immunization Research Network (CIRN), the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness to prevent influenza-related hospitalizations and serious outcomes in Canadian adults over the 2011/12 through 2013/14 influenza seasons: A pooled analysis from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS Network). Vaccine. 2018 Apr 12;36(16):2166-2175. doi: 10.1016/j.vaccine.2018.02.093. Epub 2018 Mar 13.
- Derived from this study: PubMed 29284435Andrew MK, Shinde V, Hatchette T, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney J, McGeer A, Nichols MK, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Serious Outcomes Surveillance Network and the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness against influenza-related hospitalization during a season with mixed outbreaks of four influenza viruses: a test-negative case-control study in adults in Canada. BMC Infect Dis. 2017 Dec 29;17(1):805. doi: 10.1186/s12879-017-2905-8.
- Derived from this study: PubMed 28931244Andrew MK, Shinde V, Ye L, Hatchette T, Haguinet F, Dos Santos G, McElhaney JE, Ambrose A, Boivin G, Bowie W, Chit A, ElSherif M, Green K, Halperin S, Ibarguchi B, Johnstone J, Katz K, Langley J, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McGeer A, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance Network of the Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) and the Toronto Invasive Bacterial Diseases Network (TIBDN). The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People. J Infect Dis. 2017 Aug 15;216(4):405-414. doi: 10.1093/infdis/jix282.
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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.
Shelly A McNeil, MD principal investigator
Dalhousie University
14 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, run by Dalhousie University at 14 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 3 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimate the burden of influenza disease and influenza vaccine effectiveness. (time frame: 1 Year). 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 NCT01517191, which also lists 10 linked publications.
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 30 Mar 2018.