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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2014-12-08
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)

No location data available.

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
Finalized
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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