Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults (SOS-VE01)

March 28, 2018 updated by: Dalhousie University
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.

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

4197

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, Canada
        • CHUl/CHUQ
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • The Moncton Hospital
      • Saint John, New Brunswick, Canada
        • Saint John Regional Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • QEII Health Science Centre
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health Center
      • Hamilton, Ontario, Canada
        • Mcmaster
      • Ottawa, Ontario, Canada
        • Ottawa General
      • Sudbury, Ontario, Canada, P3E 5J1
        • Advanced Medical Research Institue of Canada
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
      • Toronto, Ontario, Canada
        • Mount Sinai
    • Quebec
      • Montreal, Quebec, Canada
        • MUCH
      • Sherbrooke, Quebec, Canada
        • CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalhousie University

Collaborators

GlaxoSmithKline
Canadian Institutes of Health Research (CIHR)
Public Health Agency of Canada (PHAC)

Investigators

  • Principal Investigator: Shelly A McNeil, MD, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOS-VE01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe