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Cervarix Long-term Safety Surveillance (PGRx)

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ClinicalTrials.gov Identifier: NCT01498627
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

December 21, 2011
December 23, 2011
April 6, 2015
August 2008
December 2014   (Final data collection date for primary outcome measure)
  • 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 ]
  • To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis [ Time Frame: At Month 36 ]
  • To assess whether the use of Cervarix® is associated with a modified risk of Graves disease. [ Time Frame: At Month 36 ]
  • 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 cuataneous 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 ]
  • To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis [ Time Frame: At Month 36 ]
  • To assess whether the use of Cervarix® is associated with a modified risk of Graves disease. [ Time Frame: At Month 36 ]
Complete list of historical versions of study NCT01498627 on ClinicalTrials.gov Archive Site
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Cervarix Long-term Safety Surveillance
Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
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)

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample
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
Infections, Papillomavirus
  • Biological: Cervarix
    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).
  • Other: Data collection
    PGRx information system
  • 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.
    Interventions:
    • Biological: Cervarix
    • Other: Data collection
  • 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.
    Interventions:
    • Biological: Cervarix
    • Other: Data collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2945
1515
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
14 Years to 79 Years   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01498627
112677
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GlaxoSmithKline
GlaxoSmithKline
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Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2015