Cervarix Long-term Safety Surveillance

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01498627

Acronym

PGRx

Enrollment

2945

Registered

2011-12-23

Start date

2008-08-31

Completion date

2014-12-31

Last updated

2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Papillomavirus

Keywords

Autoimmune diseases (AIDs), Cervarix, PGRx information system

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)

Interventions

BIOLOGICALCervarix

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).

OTHERData collection

PGRx information system

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 79 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of type 1 diabetes.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of cutaneous Lupus.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of inflammatory arthritis.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of idiopathic thrombocytopenic purpura.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of systemic lupus erythematosus.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of addendum for cutaneous lupus.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of myositis.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of dermatomyositis.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Guillain-Barrre syndrome.	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of autoimmune thyroiditis	At Month 36
To assess whether the use of Cervarix® is associated with a modified risk of Graves disease.	At Month 36

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026