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

GlaxoSmithKline1,516 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,516

Conditions

Infections, Papillomavirus

Interventions

Data collectionOTHER

New onset of cases for endpoints of interest in the targeted population will be identified from ambulatory and inpatient electronic administrative data and will be confirmed by blinded review of the medical record by an Endpoint Adjudication Committee (EAC) that will confirm the AID case and will assess whether the onset of disease falls within the observation period. Fibromyalgia and psoriasis, for which a high number of cases are expected, will be identified from the electronic administrative data only.

Eligibility

Sex: FEMALEMin age: 9 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Wilmington, Delaware, United States

Outcomes

Primary Outcomes

Occurrence of new cases of confirmed neuroinflammatory autoimmune diseases and other autoimmune diseases.

Time frame: 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 Outcomes

Occurrence of new cases of confirmed systemic autoimmune diseases, organ-specific T-cell mediated autoimmune disease and organ-specific antibody-mediated autoimmune diseases.

Time frame: 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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.