116602 - Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix in the United Kingdom

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Name of medicine:
  PANDEMRIX
• Study drug International non-proprietary name (INN) or common name:
  INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
• Medical condition to be studied:
  Liver transplant rejection

  Kidney transplant rejection

  Lung transplant rejection

  Heart transplant rejection

  Pancreas transplant rejection

Population studied

• Short description of the study population:
  Subjects in the CPRD GOLD and/or HES who had experienced a solid organ transplant (SOT) rejection between 01 September 2006 and 31 October 2010.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 years)
    • Infants and toddlers (28 days – 23 months)
    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  587

Study design details

• Main study objective:
  To assess the risk of SOT rejection (liver, kidney, lung, heart, pancreas) within one month after vaccination with Pandemrix.
• Outcomes:
  Occurrence of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) within one month after vaccination with Pandemrix (from 01 October 2009 to 31 October 2010).Medical records extracted from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire. Occurrence of solid organ transplant rejection (liver, kidney, lung, heart, pancreas) within two months after vaccination with Pandemrix (from 01 October 2009 to 31 October 2010).Medical records extracted from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
• Data analysis plan:
  The association between SOT rejection and influenza vaccination (Pandemrix or seasonal influenza vaccination) was assessed by calculating the relative incidence (RI), being the ratio of the incidence rate of SOT rejection during the risk period to the incidence rate during the control period, with associated 95% confidence intervals (CI).Primary analyses for the primary objective include:- Number of rejections and person-time in each risk and control period associated with Pandemrix vaccination: control before vaccination, risk after dose1, control after dose1, risk after dose2, control after dose2, etc.- RI estimates associated with Pandemrix vaccination (all doses pooled) adjusted for time since transplantation.- RI estimates associated with Pandemrix vaccination adjusted for time since transplantation and seasonal influenza vaccination.- RI estimates associated with Pandemrix vaccination adjusted for time since transplantation and each covariate in separate models.