NCT01498627

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,945

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 6, 2015

Status Verified

April 1, 2015

Enrollment Period

6.3 years

First QC Date

December 21, 2011

Last Update Submit

April 2, 2015

Conditions

Infections, Papillomavirus

Keywords

Autoimmune diseases (AIDs)CervarixPGRx information system

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (2)

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: CervarixOther: Data collection

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: CervarixOther: Data collection

Interventions

CervarixBIOLOGICAL

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).

Case GroupControl Group
Data collectionOTHER

PGRx information system

Case GroupControl Group

Eligibility Criteria

Age14 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Papillomavirus InfectionsAutoimmune Diseases

Interventions

human papillomavirus vaccine, L1 type 16, 18Data Collection

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2011

First Posted

December 23, 2011

Study Start

August 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 6, 2015

Record last verified: 2015-04