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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Dalhousie University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Public Health Agency of Canada (PHAC)
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Information provided by (Responsible Party):
Dalhousie University
ClinicalTrials.gov Identifier:
NCT01517191
First received: January 17, 2012
Last updated: January 20, 2012
Last verified: January 2012

January 17, 2012
January 20, 2012
November 2011
May 2014   (final data collection date for primary outcome measure)
Estimate the burden of influenza disease and influenza vaccine effectiveness. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) 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 PCIRN 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2400
August 2014
May 2014   (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 within 5 days of admission:
  • community-acquired 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)

One day per week, beginning when the local laboratory reports influenza positivity rates of ≥ 5% of all tests submitted, patients admitted with the following will also be screened:

  • Acute coronary syndrome (eg myocardial infarction, unstable angina) with a triage temperature ≥37.5°C
  • Any other cardiac diagnosis (eg atrial fibrillation, other arrhythmia, myocarditis) with a triage temperature ≥ 37.5°C
  • Stroke with a triage temperature ≥37.5°C

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 cardiac, respiratory, or neurologic, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding)
  • Patients testing positive (cases) for whom immunization status cannot be ascertained will be excluded from the vaccine effectiveness analysis component of the study, however, they will still be enrolled and will be included in the burden of influenza
  • Patients testing negative for influenza (controls) for whom immunization status cannot be ascertained (by verbal self report or other source) will not be eligible for enrolment
  • No children in care will be enrolled in the study
Both
16 Years and older
No
Contact: Shelly A McNeil, MD, FRCPC 902-470-8141 shelly.mcneil@cdha.nshealth.ca
Canada
 
NCT01517191
SOS-VE01
No
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
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP