Cervarix Long-term Safety Surveillance
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections, Papillomavirus
Intervention: Cervarix (Biological); Data collection (Other)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
Study design: Observational Model: Case Control, Time Perspective: Prospective
Primary outcome: To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes. To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus. To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis. To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura. To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus. To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus. To assess whether the use of Cervarix® is associated with a modified risk of myositis. To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis. To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome. To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.
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)
Eligibility
Minimum age: 14 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 2008
Last updated: April 2, 2015
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