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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Infections, Papillomavirus	Other: Data collection

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	1516 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 Years in the US
Study Start Date :	October 2010
Actual Primary Completion Date :	September 2013
Actual Study Completion Date :	September 2013

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
Exposed cohort; Females 9-25 years of age, who received at least one dose of Cervarix® as part of their routine health care.	Other: 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®	Other: 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.

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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. ]
2. 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. ]
3. 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. ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	9 Years to 25 Years (Child, Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Females between the ages of 9-25 years

Criteria

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Delaware
GSK Investigational Site
Wilmington, Delaware, United States, 19801

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01153906 History of Changes
Other Study ID Numbers:	113522
First Posted:	June 30, 2010
Last Update Posted:	December 2, 2014
Last Verified:	September 2014

Keywords provided by GlaxoSmithKline:

autoimmune diseases; HPV vaccine; papillomavirus; human papillomavirus; HPV

Additional relevant MeSH terms:

Autoimmune Diseases; Immune System Diseases