Last updated: 11/07/2018 10:21:26

Sentinel surveillance for influenza requiring hospital admission in Canadian adults

GSK study ID
116317
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Sentinel surveillance for influenza requiring hospital admission in Canadian adults
Trial description: The purpose of this study is to assess the effectiveness of the seasonal trivalent influenza vaccine (TIV) in preventing laboratory confirmed influenza-associated hospitalizations and death in Canadian patients. The study will also assess the burden of disease, patient clinical outcomes, and use of resource associated with influenza illness. The study will also look at clinical and immunological factors impacting the severity of disease. In addition, collected samples may be used to study immune responses to influenza and other respiratory viruses and bacteria.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Occurrence of any polymerase chain reaction (PCR)-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 65 years of age.

Timeframe: Within 7 days of admission to hospital.

Secondary outcomes:

Burden of disease, clinical outcomes and resource utilization in subjects associated with influenza A and influenza B lineages.

Timeframe: Between admission and 30 days post discharge from hospital.

Occurrence of death attributed to influenza in patients < 65 years.

Timeframe: Between admission and 30 days post discharge from hospital.

Clinical risk factors impacting on severity of disease: baseline Frailty Index and Frail Scale, age, gender, underlying medical comorbidities, immunization status, smoking, obesity, pregnancy, and ethnicity.

Timeframe: At baseline upon admission and again within 30 Days post-discharge from hospital.

Severity of the disease: need for admission to an intensive care unit, need for mechanical ventilation, length of stay, and complications.

Timeframe: At baseline upon admission and again within 30 days post discharge from hospital.

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.

Timeframe: Within 7 days of admission to hospital.

Occurrence of death attributed to influenza in patients ≥ 65 years.

Timeframe: Between admission and 30 days post discharge from hospital.

Interventions:
Other: Data collection
Procedure: Nasopharyngeal swab
Procedure: Blood sample
Enrollment:
4511
Observational study model:
Case-Control
Primary completion date:
2015-28-06
Time perspective:
Prospective
Clinical publications:
McNeil S et al. (2014) Interim estimates of 2013/14 influenza clinical severity and vaccine effectiveness in the prevention of laboratory-confirmed influenza-related hospitalisation, Canada, February 2014. Euro Surveill. 19(9).
McNeil S et al. (2015) Interim estimates of 2014/15 influenza vaccine effectiveness in preventing laboratory-confirmed influenza-related hospitalisation from the Serious Outcomes Surveillance Network of the Canadian Immunization Research Network, January 2015. Euro Surveill. 20(5).
Medical condition
Influenza
Product
GSK1536489A, GSK2647158A
Collaborators
PCIRN (Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network), Canadian Center for Vaccinology
Study date(s)
December 2011 to June 2015
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
16+ years
Accepts healthy volunteers
none
  • Adult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following:
  • Pneumonia;
  • 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.

Trial location(s)

No location data available.

Study documents

Scientific result summary
Available language(s): English
Protocol
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2015-28-06
Actual study completion date
2015-28-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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