Infections, Papillomavirus
Conditions
Keywords
autoimmune diseases, HPV vaccine, papillomavirus, human papillomavirus, HPV
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.
Interventions
OTHERData collection
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.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 25 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 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. |
| 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. |
Countries
United States
Outcome results
None listed