Status:
COMPLETED
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Papillomavirus
Eligibility:
FEMALE
9-25 years
Brief Summary
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 routin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
1516 Patients enrolled
Trial Details
Trial ID
NCT01153906
Start Date
October 1 2010
End Date
September 1 2013
Last Update
December 2 2014
Active Locations (1)
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1
GSK Investigational Site
Wilmington, Delaware, United States, 19801