Cervarix Long-term Safety Surveillance

Infections, Papillomavirus Clinical Trial

— PGRx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498627
• Other study ID #: 112677
• Status: Completed
• Phase: N/A
• First received: December 21, 2011
• Last updated: April 2, 2015
• Start date: August 2008
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2945
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 79 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infections, Papillomavirus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of myositis.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis		At Month 36	No
Primary	To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.		At Month 36	No