Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults (SOS-VE01)
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ClinicalTrials.gov Identifier: NCT01517191 |
Recruitment Status :
Completed
First Posted : January 25, 2012
Last Update Posted : March 30, 2018
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Condition or disease |
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Influenza |
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 Type : | Observational |
Actual Enrollment : | 4197 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Group/Cohort |
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Influenza Positive Case
Influenza cases are hospitalized adults who have tested positive for influenza.
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Influenza Negative Control
Control Controls are hospitalized adults who have tested negative for influenza.
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- 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.
- 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 ≥ 16 years of age
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517191
Canada, British Columbia | |
Vancouver General | |
Vancouver, British Columbia, Canada | |
Canada, New Brunswick | |
The Moncton Hospital | |
Moncton, New Brunswick, Canada, E1C 6Z8 | |
Saint John Regional Hospital | |
Saint John, New Brunswick, Canada | |
Canada, Nova Scotia | |
QEII Health Science Centre | |
Halifax, Nova Scotia, Canada, B3K 6R8 | |
Canada, Ontario | |
William Osler Health Center | |
Brampton, Ontario, Canada, L6R 3J7 | |
McMaster | |
Hamilton, Ontario, Canada | |
Ottawa General | |
Ottawa, Ontario, Canada | |
Advanced Medical Research Institue of Canada | |
Sudbury, Ontario, Canada, P3E 5J1 | |
North York General Hospital | |
Toronto, Ontario, Canada, M2K 1E1 | |
Toronto East General Hospital | |
Toronto, Ontario, Canada, M4C 3E7 | |
Mount Sinai | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
MUCH | |
Montreal, Quebec, Canada | |
CHUS | |
Sherbrooke, Quebec, Canada | |
Canada | |
CHUl/CHUQ | |
Quebec, Canada, Canada |
Principal Investigator: | Shelly A McNeil, MD | Dalhousie University |
Responsible Party: | Dalhousie University |
ClinicalTrials.gov Identifier: | NCT01517191 |
Other Study ID Numbers: |
SOS-VE01 |
First Posted: | January 25, 2012 Key Record Dates |
Last Update Posted: | March 30, 2018 |
Last Verified: | March 2018 |
Influenza Respiratory Infection |
Influenza, Human Respiratory Tract Infections Infections Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Diseases |