Inactivated varicella zoster vaccine and herpes zoster

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Occurrence of herpes zoster
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Descriptive

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RECOMBINANT VARICELLA ZOSTER VIRUS GLYCOPROTEIN E

Population studied

• Short description of the study population:
  Definition of study population:; • Patients 2-99 years, both genders; • Disease codes:; o History of varicella: ICD 10 code B01 (includes events recorded 1-28 days after the vaccination prescription if the diagnosis certainty is ‘condition after’); o History of herpes zoster: ICD 10 code B02 (includes events recorded 1-28 days after the vaccination prescription if the diagnosis certainty is ‘condition after’); o History of immunodeficiency: ICD 10 codes B20-B24, C81-C96 or D80-D84; o Vaccination date: ICD 10 codes Z23-Z27; • Treatment codes:; o Treatment with inactivated varicella zoster vaccine:;  EphMRA ATC code J07E2, therapy name contains ‘shingrix’; o Treatment with live attenuated varicella zoster vaccine:;  EphMRA ATC code J07E2, therapy name not contains ‘shingrix’; o Treatment with pneumococcal vaccine:;  EphMRA ATC code J07D1:; • Conjugated vaccine: Molecule name contains ‘conjugated’ or therapy name contains ‘synflorix’; • Unconjugated vaccine: Molecule name not contains ‘conjugated’ and therapy name not contains ‘synflorix’; o Prior immunosuppressive treatment within 90 days prior vaccination prescription:;  EphMRA ATC code L01 and L04 (excluding L01X1 ‘mistletoe extracts’); o Prior immunosuppressive treatment or systemic corticosteroid treatment within 90 days prior vaccination prescription:;  EphMRA ATC code L01 L04 and H02 (excluding L01X1 ‘mistletoe extracts’); • Exclusion criteria applied: Patients are excluded in case of same day prescription for inactivated varicella zoster vaccine and either live attenuated varicella zoster vaccine or pneumococcal vaccine. Patients are required to have a minimum observation period of 180 days prior to the first vaccination prescription and at least 28 days of follow-up after the first vaccination prescription. A separate sensitivity analysis requires patients to have at least 56 days of follow-up.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The main objective of the study was to compare the occurrence of herpes zoster events up to 28 days after a vaccination prescription for inactivated varicella zoster vaccine vs. pneumococcal vaccine and live attenuated varicella zoster vaccine.
• Data analysis plan:
  The study was descriptive. The occurrence of a herpes zoster event within 28 days after a vaccination prescription was studied. Results were stratified by gender, age group, a history of varicella or herpes zoster and a history of immunodeficiency or immunosuppression.