Cervarix Long-term Safety Surveillance

GlaxoSmithKline2,945 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

2,945

Conditions

Infections, Papillomavirus

Interventions

CervarixBIOLOGICAL

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).

Data collectionOTHER

PGRx information system

Eligibility

Sex: ALLMin age: 14 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of myositis.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.

Time frame: At Month 36

To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.

Time frame: At Month 36

Data from ClinicalTrials.gov

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