Cervarix Long-term Safety Surveillance

NCT ID: NCT01498627

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2945 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2014-12-31

Brief 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.

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)

Conditions

Infections, Papillomavirus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cervarix

Intervention Type: 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

Intervention Type: OTHER

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.

Cervarix

Intervention Type: 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

Intervention Type: OTHER

PGRx information system

Interventions

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).

Intervention Type: BIOLOGICAL

Data collection

PGRx information system

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

112677

Identifier Type: -

Identifier Source: org_study_id