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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Group | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervarix | Biological | 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). |
|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects reporting an Autoimmune diseases (AID) in the previous 12 months before recruitment consultation and those whose AID is reported by physicians in general practice
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C510352 | human papillomavirus vaccine, L1 type 16, 18 |
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Data collection | Other | PGRx information system |
|
| 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 |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |