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

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.

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.