Last updated: 06/26/2019 10:50:17

Assess the risk of solid organ transplant rejection following vaccination with Pandemrix™ in UK

GSK study ID
116602
See study documents
Clinicaltrials.gov ID
NCT01715792
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: Risk of solid organ transplant rejection following vaccination with Pandemrix™ in the United Kingdom
Trial description: This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).

Timeframe: Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).

Secondary outcomes:

Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).

Timeframe: Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).

Interventions:
  • Other: Data collection
    • Enrollment:
    587
    Primary completion date:
    2013-07-08
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Cohet C et al. (2016) Effect of the adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccine on the risk of rejection in solid organ transplant recipients in England: a self-controlled case series. BMJ Open. 6(1):e009264.
    Dos Santos G et al. (2017) Adjuvanted (AS03) A/H1N1 2009 pandemic influenza vaccines and solid organ transplant rejection: systematic signal evaluation and lessons learnt. Drug Saf. doi: 10.1007/s40264-017-0532-3.
    Medical condition
    Influenza
    Product
    GSK2340274A, GSK2647158A
    Collaborators
    Not applicable
    Study date(s)
    October 2012 to August 2013
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    No
    • Subject defined as acceptable in the CPRD GOLD.
    • Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).
    • Subject from HES matched to more than one subject in the CPRD GOLD.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subject defined as acceptable in the CPRD GOLD.

      • Subject with at least one solid organ transplant rejection reported in the CPRD GOLD and/or HES during the overall study periods (01 September 2006 to 31 October 2010).
    Exclusion criteria:

      Subject from HES matched to more than one subject in the CPRD GOLD.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    London, United Kingdom, SW1W 9SZ
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    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
    2013-07-08
    Actual study completion date
    2013-07-08

    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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