Cervarix Long-term Safety Surveillance

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Infections, Papillomavirus

Intervention / Treatment
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* Biological: Cervarix
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case Group<br>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. | Biological: Cervarix<br>* 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).<br>Other: Data collection<br>* PGRx information system<br>|
| Control Group<br>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. | Biological: Cervarix<br>* 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).<br>Other: Data collection<br>* PGRx information system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 inflammatory arthritis. |  | 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 systemic lupus erythematosus. |  | At Month 36 | 
| 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 myositis. |  | 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 Guillain-Barrre syndrome. |  | 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 Graves disease. |  | At Month 36 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autoimmune diseases (AIDs), Cervarix, PGRx information system