Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
- Conditions
- Infections, Papillomavirus
- Interventions
- Other: Data collection
- Registration Number
- NCT01153906
- Lead Sponsor
- GlaxoSmithKline
- 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 routine health care.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1516
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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exposed cohort Data collection Females 9-25 years of age, who received at least one dose of Cervarix® as part of their routine health care. Unexposed cohort Data collection Females 9-25 years of age, who did not receive Cervarix®
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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. 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. 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Wilmington, Delaware, United States