Cervarix Long-term Safety Surveillance (PGRx)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01498627
First received: December 21, 2011
Last updated: April 17, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Infections, Papillomavirus
Biological: Cervarix
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess whether the use of Cervarix® is associated with a modified risk of central demyelination. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of myositis. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]
  • To assess whether the use of Cervarix® is associated with a modified risk of Graves disease. [ Time Frame: At Month 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: August 2008
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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
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.
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

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

Ages Eligible for Study:   14 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498627

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01498627     History of Changes
Other Study ID Numbers: 112677
Study First Received: December 21, 2011
Last Updated: April 17, 2014
Health Authority: France: Haute Autorité de Santé

Keywords provided by GlaxoSmithKline:
Cervarix
PGRx information system
Autoimmune diseases (AIDs)

ClinicalTrials.gov processed this record on October 20, 2014