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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed cohort | Females 9-25 years of age, who received at least one dose of Cervarix® as part of their routine health care. |
| |
| Unexposed cohort | Females 9-25 years of age, who did not receive Cervarix® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | 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. |
| Measure | Description | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Both cohorts:
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.
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Females between the ages of 9-25 years
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Wilmington | Delaware | 19801 | United States |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| 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. |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |