Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
| Status: | Completed |
|---|---|
| Conditions: | Vaccines, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 9 - 25 |
| Updated: | 5/5/2014 |
| Start Date: | October 2010 |
| End Date: | June 2014 |
| Contact: | US GSK Clinical Trials Call Center |
| Email: | GSKClinicalSupportHD@gsk.com |
| Phone: | 877-379-3718 |
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 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.
(AIDs) following females who have received at the least the first dose of Cervarix® as part
of their routine health care.
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.
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