Last updated: 06/26/2019 11:01:11

Study assessing risk of autoimmune diseases in females (9 - 25 years) exposed to Cervarix® in United Kingdom

GSK study ID
116239
See study documents
Clinicaltrials.gov ID
NCT01953822
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: An observational cohort study to assess the risk of autoimmune diseases in adolescent and young adult women aged 9 to 25 years exposed to Cervarix® in the United Kingdom
Trial description: This is an observational cohort study to assess the risk of autoimmune disease(s) within 12 months of receiving the first dose of Cervarix® in the exposed cohort and over a comparable period in the unexposed cohorts.
This is an alternative study by GSK using the CPRD database in the UK to fulfil the US FDA safety commitment. The UK has had sufficient Cervarix® vaccination coverage during the period mid-September 2008 to 2011 to allow suitable data to be collected.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of new onset of confirmed autoimmune disease for neuroinflammatory/ophthalmic autoimmune diseases

Timeframe: During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts

Occurrence of new onset of confirmed autoimmune disease for other autoimmune diseases

Timeframe: During the period of 1 year following administration of the first dose of Cervarix® (risk period) among an exposed cohort and during an equivalent time period in the unexposed cohorts

Secondary outcomes:

Occurrence of Guillain Barré syndrome (including Miller Fisher syndrome and other variants), and autoimmune haemolytic anaemia

Timeframe: Within 2 months following the administration of the first dose of Cervarix®

Occurrence of idiopathic thrombocytopenic purpura (ITP)

Timeframe: Within six months following the administration of the first dose of Cervarix®

Occurrence of new onset of individual confirmed autoimmune disease

Timeframe: Within 1 year following the administration of the first dose of Cervarix®

Interventions:
  • Other: Data collection
    • Enrollment:
    1053
    Primary completion date:
    2014-12-08
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    October 2013 to August 2014
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    9 - 25 years
    Accepts healthy volunteers
    No
    • Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses.
    • Inclusion criteria for the exposed female cohort:
    • Exclusion criteria for all cohorts:
    • Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Note: Other vaccines are allowed in this study regardless of the time of administration and the time interval between subsequent doses. Inclusion criteria for the exposed female cohort:

      • Female aged from 9 to 25 years at the reference date (01 September 2008 through 31 August 2010).
      • Recorded in the CPRD GOLD for at least 12 months before the reference date.
      • The first dose of Cervarix received between 01 September 2008 through 31 August 2010, Full date (day/month/year) of Cervarix vaccination(s) available.
      • Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed historical female cohort:
      • Female aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007).
      • Recorded in the CPRD GOLD for at least 12 months before the reference date.
      • Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed concurrent male cohort:
      • Male aged 9 to 25 years at the reference date (01 September 2008 through 31 August 2010).
      • Recorded in the CPRD GOLD for at least 12 months before the reference date.
      • Subject defined as acceptable in CPRD GOLD. Inclusion criteria for the unexposed historical male cohort:
      • Male aged 9 to 25 years at the reference date (01 September 2005 through 31 August 2007).
      • Recorded in the CPRD GOLD for at least 12 months before the reference date.
      • Subject defined as acceptable in CPRD GOLD.
    Exclusion criteria:

      Exclusion criteria for all cohorts:

      • Subjects with a diagnostic code of any auto-immune disease during the year prior to the reference date.
      • Subjects who received at least one dose of unspecified HPV vaccine or Gardasil at any time before the reference date.
      • Subjects who have been included in the other cohort. Exclusion criteria for the non-exposed cohorts:
      • Subjects who received any dose of Cervarix at any time before the reference date.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    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
    2014-12-08
    Actual study completion date
    2014-12-08

    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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