Trials / Completed
CompletedNCT01153906
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination in Females Aged 9-25 Years in the US
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,516 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 9 Years – 25 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2010-06-30
- Last updated
- 2014-12-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01153906. Inclusion in this directory is not an endorsement.