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

CompletedOBSERVATIONAL
Enrollment

1,516

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2013

Conditions
Infections, Papillomavirus
Interventions
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.

Trial Locations (1)

19801

GSK Investigational Site, Wilmington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01153906 - Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination | Biotech Hunter | Biotech Hunter