205639 - Meta-analysis of the risk of autoimmune thyroiditis diseases, Guillain-Barré Syndrome, and Inflammatory Bowel Disease with Cervarix Vaccination

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BM02) papillomavirus (human types 16, 18)

  papillomavirus (human types 16, 18)
• Medical condition to be studied:
  Autoimmune thyroiditis

  Guillain-Barre syndrome

  Inflammatory bowel disease

Population studied

• Short description of the study population:
  Female subjects aged 9 years and above who had received Cervarix Vaccine.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Estimated number of subjects:
  1

Study design details

• Main study objective:
  This study will estimate the overall risk of developing three autoimmune diseases (autoimmune thyroiditis, Guillain Barre Syndrome and Inflammatory Bowel diseases) following Cervarix vaccination in females.
• Outcomes:
  Occurrence of cases of autoimmune thyroiditis, Guillain-Barré Syndrome, and Inflammatory Bowel Disease during 2 years after the first dose of Cervarix.
• Data analysis plan:
  Meta-analysis method with continuity correction. A continuity correction will be applied to all studies to overcome the single- and double- zero issue. Various continuity corrections have been proposed: constant continuity correction k (for example k=0.5 is commonly used in many software’s), continuity correction reciprocal of the opposite treatment arm size, empirical continuity correction.Advantage of this method is that all studies can be included, and any metaanalysis calculation method (inverse variance-weighted method, Peto’s method, Mantel-Haenszel’s method, etc.) can be applied, all individual studies can also be depicted in forest plots, and heterogeneity among studies can be estimated and tested.