Cervarix Long-term Safety Surveillance

Completed

• Conditions: Infections, Papillomavirus
• Interventions: Biological: Cervarix; Other: Data collection

• Registration Number: NCT01498627
• Lead Sponsor: GlaxoSmithKline

Brief 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)

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2011-12-21
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-23
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-02
• Last Update Posted: 2015-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2945

Inclusion Criteria

• Male and female
• Age 14 to 79 years-old (included)
• Patient residing in France
• Patient accepting to participate in the study
• Patient can read and respond to a telephone interview

Exclusion Criteria

• Prior reported history of the disease
• Patient or Patient's parent cannot read the interview guide or answer a telephone interview questionnaire in French
• Refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	Data collection	Subjects in this group are incident cases (i.e. newly diagnosed subjects) reported as having occurred in the previous twelve months before the recruitment consultation.
Control Group	Cervarix	Subjects selected from the pool of potential referents reported by physicians in general practice, who meet the same general inclusion and exclusion criteria as the cases.
Case Group	Cervarix	Subjects in this group are incident cases (i.e. newly diagnosed subjects) reported as having occurred in the previous twelve months before the recruitment consultation.
Control Group	Data collection	Subjects selected from the pool of potential referents reported by physicians in general practice, who meet the same general inclusion and exclusion criteria as the cases.

Primary Outcome Measures

Name	Time	Method
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of myositis.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.	At Month 36