Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
Completed
Conditions studied: Infections, Papillomavirus
In brief
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.
Key facts
- Study ID
- NCT01153906
- Run by
- GlaxoSmithKline
- People needed
- 1516
- Starts
- 2010-10-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2014-12-02
Who can join
Age: 9 and older, up to 25. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- GSK Investigational Site — Wilmington, Delaware, United States
Full record on ClinicalTrials.gov
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