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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
Sponsor:
Collaborators:
Public Health Agency of Canada (PHAC)
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Information provided by (Responsible Party):
Dalhousie University

January 17, 2012
January 25, 2012
March 30, 2018
November 2011
December 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01517191 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults
Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults
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.

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
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum and Nasopharyngeal swabs
Probability Sample
This observational study is open to adults admitted to hospital with test postitive influenza or with an influenza like illness who test negative.
Influenza
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4197
2400
December 2016
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01517191
SOS-VE01
No
Not Provided
Not Provided
Dalhousie University
Dalhousie University
  • Public Health Agency of Canada (PHAC)
  • Canadian Institutes of Health Research (CIHR)
  • GlaxoSmithKline
Principal Investigator: Shelly A McNeil, MD Dalhousie University
Dalhousie University
March 2018