Cervarix Long-term Safety Surveillance (PGRx)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Papillomavirus

Treatments: Other: Data collection; Biological: Cervarix

Study type: Observational

Funder types: Industry

Identifiers

NCT01498627

112677

Details and patient eligibility

About

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.

Full 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)

Enrollment: 2,945 patients

Sex: All

Ages: 14 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,945 participants in 2 patient groups

Case Group

Description:

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.

Treatment:

Biological: Cervarix

Other: Data collection

Control Group

Description:

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.

Treatment:

Biological: Cervarix

Other: Data collection