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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01153906

Purpose

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	Intervention
Autoimmune Diseases	Other: Data collection

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 10-25 Years in the US

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Fibromyalgia Psoriasis

Drug Information available for: Human papillomavirus vaccine, L1 type 16, 18

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Estimated Enrollment:	140000
Study Start Date:	October 2010
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Exposed cohort Females 10-25 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 10-25 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.

Groups/Cohorts

Assigned Interventions

Exposed cohort

Females 10-25 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 10-25 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.

Eligibility

Ages Eligible for Study:	10 Years to 25 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Females between the ages of 10-25 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 10 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153906

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Locations

United States, Delaware
GSK Investigational Site	Recruiting
Wilmington, Delaware, United States, 19801
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01153906 History of Changes
Other Study ID Numbers:	113522
Study First Received:	June 29, 2010
Last Updated:	August 18, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

HPV
human papillomavirus
autoimmune diseases
HPV vaccine
papillomavirus

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 24, 2012