Clinical trial · Observational
Cervarix Long-term Safety Surveillance
Cervarix Long-term Safety Surveillance Using the PGRx Information System (PGRx Study)
NCT01498627CI-TRIAL-00017394PGRxcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infections, Papillomavirus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervarix | Biological | — | UNRESOLVED |
| Data collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Biological: Cervarix
- Other: Data collection
- label
- 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.
- interventionNames
- Biological: Cervarix
- Other: Data collection
Primary outcomes (12)
- measure
- To assess whether the use of Cervarix® is associated with a modified risk of central demyelination.
- timeFrame
- At Month 36
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.