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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date January 17, 2012
First Posted Date January 25, 2012
Last Update Posted Date March 30, 2018
Study Start Date November 2011
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 20, 2012)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01517191 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 20, 2012)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults
Official Title Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum and Nasopharyngeal swabs
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.
Condition Influenza
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 28, 2018)
4197
Original Estimated Enrollment
 (submitted: January 20, 2012)
2400
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01517191
Other Study ID Numbers SOS-VE01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dalhousie University
Study Sponsor Dalhousie University
Collaborators
  • Public Health Agency of Canada (PHAC)
  • Canadian Institutes of Health Research (CIHR)
  • GlaxoSmithKline
Investigators
Principal Investigator: Shelly A McNeil, MD Dalhousie University
PRS Account Dalhousie University
Verification Date March 2018