Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults

NCT01517191 | Completed

• 1 other identifier: SOS-VE01
• Study Type: observational
• Target: 4,197
• Locations: 1 country
• Sites: 14

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.

Conditions

Influenza

Keywords

Influenza; Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• Estimate the burden of influenza disease and influenza vaccine effectiveness.

  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.

  1 Year

Secondary Outcomes (1)

• Estimate the burden of influenza disease and influenza vaccine effectiveness.

  1 Year

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalhousie University: lead
• Public Health Agency of Canada (PHAC): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• GlaxoSmithKline: collaborator

Study Sites (14)

Vancouver General

Vancouver, British Columbia, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Location

QEII Health Science Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

William Osler Health Center

Brampton, Ontario, L6R 3J7, Canada

Location

Advanced Medical Research Institue of Canada

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

McMaster

Hamilton, Ontario, Canada

Location

Ottawa General

Ottawa, Ontario, Canada

Location

North York General Hospital

Toronto, Ontario, M2K 1E1, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

Mount Sinai

Toronto, Ontario, Canada

Location

MUCH

Montreal, Quebec, Canada

Location

CHUS

Sherbrooke, Quebec, Canada

Location

CHUl/CHUQ

Québec, Canada, Canada

Location

Related Publications (10)

• Pott H, LeBlanc JJ, ElSherif M, Hatchette TF, Andrew MK, McNeil SA. Human Metapneumovirus Epidemiology Among Middle-aged and Older Adults Hospitalized With Acute Respiratory Infection. J Infect Dis. 2025 Jul 16;232(Supplement_1):S69-S77. doi: 10.1093/infdis/jiaf083.

  PMID: 40668096 DERIVED

• Pott H, Andrew MK, Shaffelburg Z, Nichols MK, Ye L, ElSherif M, Hatchette TF, LeBlanc JJ, Ambrose A, Boivin G, Bowie W, Johnstone J, Katz K, Lagace-Wiens P, Loeb M, McCarthy A, McGeer A, Poirier A, Powis J, Richardson D, Semret M, Smith S, Smyth D, Stiver G, Trottier S, Valiquette L, Webster D, McNeil SA. Oseltamivir Reduces 30-Day Mortality in Older Adults With Influenza: A Pooled Analysis From the 2012-2019 Serious Outcomes Surveillance Network of the Canadian Immunization Research Network. Open Forum Infect Dis. 2025 Feb 3;12(2):ofaf058. doi: 10.1093/ofid/ofaf058. eCollection 2025 Feb.

  PMID: 39968306 DERIVED

• Shoukat A, Bawden CE, Rost G, LeBlanc JJ, Galvani AP, Langley JM, Moghadas SM. Impact and cost-effectiveness analyses of vaccination for prevention of respiratory syncytial virus disease among older adults in Ontario: A Canadian Immunization Research Network (CIRN) study. Vaccine. 2024 Mar 7;42(7):1768-1776. doi: 10.1016/j.vaccine.2024.02.041. Epub 2024 Feb 16.

  PMID: 38368226 DERIVED

• 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.

  PMID: 36069141 DERIVED

• 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.

  PMID: 31264957 DERIVED

• 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.

  PMID: 30616737 DERIVED

• 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.

  PMID: 30508064 DERIVED

• 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.

  PMID: 29548608 DERIVED

• 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.

  PMID: 29284435 DERIVED

• 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.

  PMID: 28931244 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Nasopharyngeal swabs

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Shelly A McNeil, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 25, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

CA (14)