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

• ClinicalTrials.gov Identifier: NCT01517191
• Recruitment Status: Completed
• First Posted: January 25, 2012
• Last Update Posted: March 30, 2018
• Sponsor: Dalhousie University
• Collaborators: Public Health Agency of Canada (PHAC); Canadian Institutes of Health Research (CIHR); GlaxoSmithKline
• Information provided by (Responsible Party): Dalhousie University

Study Description

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 Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: 16 Years and older (Child, Adult, Older Adult)
• 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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mulpuru S, Andrew MK, Ye L, Hatchette T, LeBlanc J, El-Sherif M, MacKinnon-Cameron D, Aaron SD, Alvarez GG, Forster AJ, Ambrose A, McNeil SA; Serious Outcomes Surveillance and Canadian Immunization Research Network (CIRN) Investigators. Impact of respiratory viral infections on mortality and critical illness among hospitalized patients with chronic obstructive pulmonary disease. Influenza Other Respir Viruses. 2022 Nov;16(6):1172-1182. doi: 10.1111/irv.13050. Epub 2022 Sep 7.

LeBlanc JJ, ElSherif M, Mulpuru S, Warhuus M, Ambrose A, Andrew M, Boivin G, Bowie W, Chit A, Dos Santos G, Green K, Halperin SA, Hatchette TF, Ibarguchi B, Johnstone J, Katz K, Langley JM, Lagace-Wiens P, Loeb M, Lund A, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Poirier A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, Ye L, McNeil SA. Validation of the Seegene RV15 multiplex PCR for the detection of influenza A subtypes and influenza B lineages during national influenza surveillance in hospitalized adults. J Med Microbiol. 2020 Feb;69(2):256-264. doi: 10.1099/jmm.0.001032. Epub 2019 Jun 28.

Mulpuru S, Li L, Ye L, Hatchette T, Andrew MK, 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 JE, McGeer A, Powis J, Richardson D, Semret M, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). Effectiveness of Influenza Vaccination on Hospitalizations and Risk Factors for Severe Outcomes in Hospitalized Patients With COPD. Chest. 2019 Jan;155(1):69-78. doi: 10.1016/j.chest.2018.10.044.

Nichols MK, Andrew MK, Ye L, Hatchette TF, Ambrose A, Boivin G, Bowie W, Dos Santos G, Elsherif M, Green K, Haguinet F, Katz K, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McElhaney JE, McGeer A, Powis J, Richardson D, Semret M, Sharma R, Shinde V, Smyth D, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance (SOS) Network of the Canadian Immunization Research Network (CIRN). The Impact of Prior Season Vaccination on Subsequent Influenza Vaccine Effectiveness to Prevent Influenza-related Hospitalizations Over 4 Influenza Seasons in Canada. Clin Infect Dis. 2019 Aug 30;69(6):970-979. doi: 10.1093/cid/ciy1009.

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, Lagace-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.

Andrew MK, Shinde V, Ye L, Hatchette T, Haguinet F, Dos Santos G, McElhaney JE, Ambrose A, Boivin G, Bowie W, Chit A, ElSherif M, Green K, Halperin S, Ibarguchi B, Johnstone J, Katz K, Langley J, Leblanc J, Loeb M, MacKinnon-Cameron D, McCarthy A, McGeer A, Powis J, Richardson D, Semret M, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA; Serious Outcomes Surveillance Network of the Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) and the Toronto Invasive Bacterial Diseases Network (TIBDN). The Importance of Frailty in the Assessment of Influenza Vaccine Effectiveness Against Influenza-Related Hospitalization in Elderly People. J Infect Dis. 2017 Aug 15;216(4):405-414. doi: 10.1093/infdis/jix282.

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

Keywords provided by Dalhousie University:

Influenza; Respiratory Infection

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases