Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination

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Date First Received: June 29, 2010
Overall Status: Not yet recruiting

Last Updated: June 29, 2010
Verified by: GlaxoSmithKline, June 2010
Clinical Trial Phase: N/A | Start Date: July 201

Estimated Enrollment: 100000

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…

Brief Summary

Official Title: “Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 10-25 Years in the US”

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.

Study Type: Observational

Study Design: Observational Model: Cohort, Time Perspective: Prospective

Study Primary Completion Date: September 2014

Intervention(s) in this Clinical Trial

  • Other: Data collection
    • New onset of cases for endpoints of interest in the targeted population will be identified from ambulatory and inpatient electronic administrative data and will be confirmed by blinded review of the medical record by an Endpoint Adjudication Committee (EAC) that will confirm the AID case and will assess whether the onset of disease falls within the observation period. Fibromyalgia and psoriasis, for which a high number of cases are expected, will be identified from the electronic administrative data only.

Arms, Groups and Cohorts in this Clinical Trial

* : Exposed cohort
o Females 10-25 years of age, who received at least one dose of Cervarix® as part of their routine health care.
* : Unexposed cohort
o Females 10-25 years of age, who did not receive Cervarix®

Outcome Measures for this Clinical Trial
Primary Measures

* Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.
o Time Frame: 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.
Safety Issue?: No

Secondary Measures

* Occurrence of new cases of psoriasis
o Time Frame: 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.
Safety Issue?: No
* Occurrence of new cases of confirmed systemic autoimmune diseases, organ-specifiec T-cell mediated autoimmune disease and organ-specific antibody-mediated autoimmune diseases.
o Time Frame: 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.
Safety Issue?: No
* Occurrence of new cases of fibromyalgia
o Time Frame: 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.
Safety Issue?: No

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.