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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Papillomavirus

Treatments: Other: Data collection

Study type: Observational

Funder types: Industry

Identifiers

NCT01153906

113522

Details and patient eligibility

About

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.

Enrollment: 1,516 patients

Sex: Female

Ages: 9 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,516 participants in 2 patient groups

Exposed cohort

Description:

Females 9-25 years of age, who received at least one dose of Cervarix® as part of their routine health care.

Treatment:

Other: Data collection

Unexposed cohort

Description:

Females 9-25 years of age, who did not receive Cervarix®

Treatment:

Other: Data collection