Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01153906 |
Recruitment Status
:
Completed
First Posted
: June 30, 2010
Last Update Posted
: December 2, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Infections, Papillomavirus | Other: Data collection |
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 |

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.
|
- 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. ]
- 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. ]
- 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. ]
- 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. ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 9 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01153906
United States, Delaware | |
GSK Investigational Site | |
Wilmington, Delaware, United States, 19801 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT01153906 History of Changes |
Other Study ID Numbers: |
113522 |
First Posted: | June 30, 2010 Key Record Dates |
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 |