Infections, Papillomavirus Clinical Trial
Official title:
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 Years in the US
Verified date | September 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1516 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 9 Years to 25 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | GSK Investigational Site | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases. | 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. | No | |
Secondary | Occurrence of new cases of confirmed systemic autoimmune diseases, organ-specific T-cell mediated autoimmune disease and organ-specific antibody-mediated autoimmune diseases. | 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. | No | |
Secondary | Occurrence of new cases of fibromyalgia | 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. | No | |
Secondary | Occurrence of new cases of psoriasis | 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. | No |
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