Last updated: 03/06/2019 10:10:15

Post-marketing safety study of autoimmune diseases following Cervarix® vaccination

GSK study ID
113522
See study documents
Clinicaltrials.gov ID
NCT01153906
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: Post-marketing safety study of autoimmune diseases following Cervarix® vaccination in females aged 9-25 years in the US
Trial description: The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.

Timeframe: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.

Secondary outcomes:

Occurrence of new cases of confirmed systemic autoimmune diseases, organ-specific T-cell mediated autoimmune disease and organ-specific antibody-mediated autoimmune diseases.

Timeframe: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.

Occurrence of new cases of fibromyalgia

Timeframe: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.

Occurrence of new cases of psoriasis

Timeframe: During the 12-month period following administration of at least the first dose of Cervarix® among the exposed cohort and during an equivalent time period among the unexposed cohort.

Interventions:
  • Other: Data collection
    • Enrollment:
    1516
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Papillomavirus
    Product
    SB580299
    Collaborators
    Not applicable
    Study date(s)
    October 2010 to September 2014
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female
    Age
    9 - 25 years
    Accepts healthy volunteers
    Yes
    • Both cohorts:
    • Have complete medical insurance coverage and pharmacy benefits.
    • Both cohorts:
    • Subjects with a diagnostic code of any of the AID endpoints of interest during the one year prior to the index date.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Both cohorts:

      • Have complete medical insurance coverage and pharmacy benefits.
      • Enrolled female health plan members for at least one year prior to study entry.
      • Age between 9 and 25 years at study entry. Exposed cohort:
      • Subjects who have received at least one dose of Cervarix®, with or without any other US age-appropriate recommended vaccines. Unexposed cohort:
      • No further specific inclusion criteria
    Exclusion criteria:

      Both cohorts:

      • Subjects with a diagnostic code of any of the AID endpoints of interest during the one year prior to the index date. Exposed cohort:
      • Subjects who received any dose of Gardasil® prior to the first dose of Cervarix®. Unexposed cohort:
      • Subjects who receive any dose of Cervarix® prior to the index date.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wilmington, Delaware, United States, 19801
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    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
    2014-04-09

    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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