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
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
Not applicable
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
Finalized
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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