NCT01498627

Cervarix Long-term Safety Surveillance

Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,945 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 14 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.

Detailed description

PGRx is an information system that intends to bridge the resource gap to assess the effect of a drug on the risk of adverse events that are infrequent and/or with a long delay of onset. It uses some characteristics of the ad hoc case-control or case-referent design, transposed on a prospective, on-going, population-based recruitment plan. This particular design is called here systematic case-referent design in contrast to the ad hoc case-control or case-referent methodology. The PGRx information system is based on the routine and targeted recruitment of cases of a series of pathologies, compared to population-based referents for the study of exposure to a wide variety of drugs. Drug exposure ascertainment is obtained from two different sources in the PGRx. system: A) A structured patient interview (telephone-administered questionnaire) B) The medical data form with the computerized medical prescriptions (interview guide)

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix	3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
OTHER	Data collection	PGRx information system

Timeline

• Start date: 2008-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-12-23
• Last updated: 2015-04-06