Last updated: 11/07/2018 10:20:47

Cost of illness associated with influenza in the UK

GSK study ID
116313
See study documents
Clinicaltrials.gov ID
NCT01521416
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The cost of illness associated with influenza in the UK
Trial description: The objective of this study is to describe the burden associated with influenza in the UK, from both primary and secondary care perspectives, and to stratify the burden by the annual degree of mismatch between predicted and actual virus strains.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence of influenza-related events

Timeframe: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Number of confirmed influenza infections

Timeframe: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Assessment of resource use

Timeframe: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Evaluation of patient outcomes, treatments and costs (type and duration)

Timeframe: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Cause of deaths

Timeframe: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Incidence of influenza-related events in High Risk groups

Timeframe: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Incidence of complications and exacerbations

Timeframe: Over the study time period (from January 21st 2001 to March 31st 2009 inclusive)

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Only
    Time perspective:
    Retrospective
    Clinical publications:
    Pockett RD et al. (2015) Burden of illness in UK subjects with reported respiratory infections vaccinated or unvaccinated against influenza: A retrospective observational study. PLoS One. 10(8):e0134928.
    Medical condition
    Influenza
    Product
    GSK2647158A
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to April 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    5 - 65 years
    Accepts healthy volunteers
    No
    • Male or female patients coded within the database as having acute respiratory events that could be related to an infection between 2001 and 2009.
    • Patients must have a minimum of 14 days observation before and after the index event to permit the capturing of complications attributable to influenza.
    • Not Applicable
    Inclusion and exclusion criteria
    Inclusion criteria:

      Male or female patients coded within the database as having acute respiratory events that could be related to an infection between 2001 and 2009.

      • Patients must have a minimum of 14 days observation before and after the index event to permit the capturing of complications attributable to influenza.
    Exclusion criteria:
    • Not Applicable

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2013-30-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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