Last updated: 11/07/2018 04:57:51

Cervarix long-term safety surveillancePGRx

GSK study ID
112677
See study documents
Clinicaltrials.gov ID
NCT01498627
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: Cervarix long-term safety surveillance using the PGRx information system (PGRx study)
Trial description: This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of myositis.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis

Timeframe: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.

Timeframe: At Month 36

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Cervarix
  • Other: Data collection
    • Enrollment:
    2945
    Primary completion date:
    2014-17-12
    Observational study model:
    Case-Control
    Time perspective:
    Prospective
    Clinical publications:
    Grimaldi-Bensouda L et al. (2017) Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: Six years of case-referent surveillance. J Autoimmun. pii: S0896-8411(16)30214-1. doi: 10.1016/j.jaut.2017.01.005.
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    August 2008 to December 2014
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    14 - 79 years
    Accepts healthy volunteers
    Yes
    • Male and female
    • Age 14 to 79 years-old (included)
    • Prior reported history of the disease
    • Patient or Patient’s parent cannot read the interview guide or answer a telephone interview questionnaire in French
    Inclusion and exclusion criteria
    Inclusion criteria:

      Male and female

      • Age 14 to 79 years-old (included)
      • Patient residing in France
      • Patient accepting to participate in the study
      • Patient can read and respond to a telephone interview
    Exclusion criteria:

      Prior reported history of the disease

      • Patient or Patient’s parent cannot read the interview guide or answer a telephone interview questionnaire in French
      • Refusal to participate

    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)

    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
    2014-17-12
    Actual study completion date
    2014-17-12

    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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