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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

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.

Condition or disease
Influenza

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
Actual Enrollment : 4197 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults
Study Start Date : November 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples Without DNA
Serum and Nasopharyngeal swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517191


Locations
Canada, British Columbia
Vancouver General
Vancouver, British Columbia, Canada
Canada, New Brunswick
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Canada, Nova Scotia
QEII Health Science Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
William Osler Health Center
Brampton, Ontario, Canada, L6R 3J7
McMaster
Hamilton, Ontario, Canada
Ottawa General
Ottawa, Ontario, Canada
Advanced Medical Research Institue of Canada
Sudbury, Ontario, Canada, P3E 5J1
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Mount Sinai
Toronto, Ontario, Canada
Canada, Quebec
MUCH
Montreal, Quebec, Canada
CHUS
Sherbrooke, Quebec, Canada
Canada
CHUl/CHUQ
Quebec, Canada, Canada
Sponsors and Collaborators
Dalhousie University
Public Health Agency of Canada (PHAC)
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Investigators
Principal Investigator: Shelly A McNeil, MD Dalhousie University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Nichols MK, Andrew MK, Hatchette TF, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Lagacé-Wiens P, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Schuind A, Semret M, Shinde V, Smith S, Smyth D, Stiver G, Taylor G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Serious Outcomes Surveillance Network of the Canadian Immunization Research Network (CIRN), the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness to prevent influenza-related hospitalizations and serious outcomes in Canadian adults over the 2011/12 through 2013/14 influenza seasons: A pooled analysis from the Canadian Immunization Research Network (CIRN) Serious Outcomes Surveillance (SOS Network). Vaccine. 2018 Apr 12;36(16):2166-2175. doi: 10.1016/j.vaccine.2018.02.093. Epub 2018 Mar 13.
Andrew MK, Shinde V, Hatchette T, Ambrose A, Boivin G, Bowie W, Chit A, Dos Santos G, ElSherif M, Green K, Haguinet F, Halperin SA, Ibarguchi B, Johnstone J, Katz K, Langley JM, LeBlanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney J, McGeer A, Nichols MK, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Serious Outcomes Surveillance Network and the Toronto Invasive Bacterial Diseases Network (TIBDN). Influenza vaccine effectiveness against influenza-related hospitalization during a season with mixed outbreaks of four influenza viruses: a test-negative case-control study in adults in Canada. BMC Infect Dis. 2017 Dec 29;17(1):805. doi: 10.1186/s12879-017-2905-8.

Responsible Party: Dalhousie University
ClinicalTrials.gov Identifier: NCT01517191     History of Changes
Other Study ID Numbers: SOS-VE01
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

Keywords provided by Dalhousie University:
Influenza
Respiratory Infection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases