Last updated: 11/07/2018 10:19:03

Influenza burden assessment in the United Kingdom, 1996-2008

GSK study ID
116273
See study documents
Clinicaltrials.gov ID
NCT01520935
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: Burden of Influenza in the United Kingdom, 1996-2008
Trial description: The study will assess the burden of influenza by age, risk status, vaccination status and influenza subtype, in order to create a complete profile of the burden of influenza-related morbidity and mortality in United Kingdom from 1996 to 2008.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence of medically attended health outcomes (~20 relevant mild and severe) related to influenza

Timeframe: From 1996 to 2008 (up to 13 years)

Relative impact of influenza on high versus low risk populations

Timeframe: From 1996 to 2008 (up yo 13 years)

Relative impact of influenza during match versus mismatched seasons

Timeframe: From 1996 to 2008 (up to 13 years)

Relative impact of influenza on vaccinated versus unvaccinated populations

Timeframe: From 1996 to 2008 (up to 13 years)

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Bekkat-Berkani R et al. (2016) Evidence update: GlaxoSmithKline’s inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 15(2):201-214.
    Fleming DM et al. (2016) Influenza-attributable burden in United Kingdom primary care. Epidemiol Infect. 144(3):537-547.
    Medical condition
    Influenza
    Product
    GSK2647158A
    Collaborators
    Sage Analytica
    Study date(s)
    September 2011 to October 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Registration with an acceptable flag in the GPRD, or registration with a potentially influenza-related event in the HES database or the ONS mortality data.

    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
    2012-03-10

    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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