Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
NCT ID: NCT01153906
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1516 participants
OBSERVATIONAL
2010-10-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exposed cohort
Females 9-25 years of age, who received at least one dose of Cervarix® as part of their routine health care.
Data 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.
Unexposed cohort
Females 9-25 years of age, who did not receive Cervarix®
Data 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.
Interventions
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Data 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.
Eligibility Criteria
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Inclusion Criteria
* 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:
Exclusion Criteria
• 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.
9 Years
25 Years
FEMALE
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Wilmington, Delaware, United States
Countries
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Other Identifiers
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113522
Identifier Type: -
Identifier Source: org_study_id