Study of Cervarix & Idiopathic Thrombocytopenic Purpura using the PGRx information system

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN

  HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
• Medical condition to be studied:
  Demyelination

  Type 1 diabetes mellitus

  Cutaneous lupus erythematosus

  Arthritis infective

  Immune thrombocytopenia

  Systemic lupus erythematosus

  Autoimmune thyroiditis

  Dermatomyositis

  Guillain-Barre syndrome

  Myositis

Population studied

• Short description of the study population:
  Study subjects were cases and referents from the PGRx system satisfying with the following criteria:; 1. Female gender; 2. Age 14 to 26 years old; 3. Patient residing in France (continental); 4. Patient accepting to participate in the study
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  2945

Study design details

• Main study objective:
  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), systemic lupus erythematosus, myositis and dermatomyositis, Guillain-Barre syndrome and/or Autoimmune thyroiditis and Graves disease by using the PGRx information system.
• Outcomes:
  To assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes, cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, myositis, dermatomyositis, Guillain-Barre syndrome, autoimmune thyroiditis and/or Graves disease at 36 months after the first index case included in the PGRx system.
• Data analysis plan:
  Mainly, two types of analyses are performed with the case-referent design. One without a priori hypothesis the crude analysis (CA) and the other with specific a priori hypotheses the in-depth analysis (IA). The CA is a comparison between cases and referents for their exposure to therapeutic product. The association between an exposure and the occurrence of an adverse event (AE) is quantified through a crude odds ratio (COR) with 90% CI. The COR is not adjusted for the various risk factors (RFs) and not subjected to particular risk curve modelling. In the case of IA, a specific hypothesis is specified and tested regarding an AE and exposure to a specific drug or therapeutic class. This analysis is performed using multivariate techniques with all RFs for a specific pathology as well as co-medications. The association between drug and occurrence of an AE is quantified through adjusted OR with 95% CI. Sensitivity analysis can be performed to assess the robustness of the results.

Documents

Study results

gsk-112677-Clinical-Study-Report_1-redact

gsk-112677-Clinical-Study-Report_2-redact

Study report

gsk-112677-clinical-study-report-redact

gsk-112677-Clinical-Study-Report_3-redact

Study, other information

gsk-112677-Clinical-Study-Report_3-redact.pdf

Study publications

Grimaldi-Bensouda L, Rossignol M, Koné-Paut I, Krivitzky A, Lebrun-Frenay C, Cl…