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Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults

Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01517191
Acronym
SOS-VE01
Enrollment
4197
Registered
2012-01-25
Start date
2011-11-30
Completion date
2016-12-31
Last updated
2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Respiratory Infection

Brief 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. 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: 1. 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, 2. To determine the effectiveness of influenza vaccination in preventing influenza-associated death in adults ≥ 65 years 3. To determine the effectiveness of influenza vaccination in preventing influenza-associated hospitalization and death in adults \< 65 years 4. To characterize the burden of disease, clinical outcomes, and resource utilization associated with influenza A and influenza B lineages 5. To examine clinical and immunologic factors impacting on severity of disease and influenza vaccine effectiveness in adults

Interventions

None listed

Sponsors

Public Health Agency of Canada (PHAC)
CollaboratorOTHER_GOV
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
GlaxoSmithKline
CollaboratorINDUSTRY
Dalhousie University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Estimate the burden of influenza disease and influenza vaccine effectiveness.1 YearOccurrence of any PCR-confirmed influenza virus infection in vaccinated (\>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 65 years of age.

Secondary

MeasureTime frameDescription
Estimate the burden of influenza disease and influenza vaccine effectiveness.1 YearOccurrence of any PCR-confirmed influenza virus infection in vaccinated (\>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 16 years of age

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026