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Completed

NCT Number: NCT01498627

Cervarix Long-term Safety Surveillance

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.

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Key information

Conditions

Infections, Papillomavirus Autoimmune Diseases Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Immune System Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

14 year–79 year

Sex eligibility

All sexes

Study type

Observational

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Data Collection

Other

PGRx information system

Primary outcomes

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

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

    Time frame: At Month 36

  11. To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis

    Time frame: At Month 36

  12. To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.

    Time frame: At Month 36

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Acronym: PGRx

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 23, 2011
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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