212853 - Shingrix for intramuscular injection Drug Use Investigation

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Study drug and medical condition

• Medicinal product name:
  SHINGRIX
• Study drug International non-proprietary name (INN) or common name:
  HERPES ZOSTER VACCINE (RECOMBINANT, ADJUVANTED)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BK03) zoster, purified antigen

  zoster, purified antigen
• Medical condition to be studied:
  Herpes zoster

Population studied

• Short description of the study population:
  Persons vaccinated with Shingrix for the first time, for the purpose of preventing zoster.
• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  7500

Study design details

• Main study objective:
  To assess the presence or absence of issues and concerns related to safety of Shingrix under practical use conditions.
• Setting:
  Medical institutes, mainly internal medicine, where agreed to be participate in this investigation (approximately 1,000 sites)
• Outcomes:
  Occurrence of Solicited adverse events and Unsolicited adverse events
• Data analysis plan:
  Analytical methods include: ; - Safety: calculate incidence proportion of vaccine related adverse reaction. ; - Consideration of covariates: consideration for covariates which may relate to safety (incidence proportion of vaccine related adverse reaction) by calculation odds ratio and 95% confidence interval, figure out forest-plot if necessary.