An Active Safety Surveillance Study for Prevenar 13® Among Chinese Children

Study type

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

Study drug and medical condition

• Medicinal product name:
  PREVENAR 13

Population studied

• Short description of the study population:
  Infants and children 6 weeks through 5 years of age who received at least 1 dose of Prevenar 13 and were recorded in the selected EHR databases in the selected study period

Study design details

• Study design:
  Observational, uncontrolled, descriptive study design for non-interventional active safety surveillance based on population-based EHR databases
• Main study objective:
  To estimate the incidence rates of safety outcomes of interest (SOIs), including seizures (including febrile seizures), urticaria, angioedema, fever, TP, ITP, HSP, and anaphylaxis/anaphylactic reaction, laryngeal oedema, and Arthus reaction, for a prespecified risk period after Prevenar 13 vaccination (ie, risk interval), among Chinese infants and children 6 weeks through 5 years of age for all doses and for each dose.
• Setting:
  The study population will include eligible infants and children 6 weeks through 5 years of age who received at least 1 dose of Prevenar 13 and were recorded in the selected EHR databases during the study period. Eligible children are followed for SOIs in the selected regional health information platform (RHIP) from the date of their first dose of Prevenar 13 vaccination until the SOI-related risk interval or SOI-related predefined monitoring period (which is 6 months after vaccination for TP, ITP, HSP, and Arthus reaction) after the last dose of Prevenar 13, moving out of the district, death, or the end of the study (whichever occurs first).
• Data analysis plan:
  All analyses for the study will be descriptive. Incidence rates per 100,000 person-days (or 10,000 person-days) at risk and per 100,000 doses (or 10,000 doses), and the 95% CIs for the safety outcomes of interest (SOI), will be calculated for the SOI-related risk intervals after vaccination for all doses and for each dose. Analyses will be conducted separately for each regional database. Incidence of each SOI from the selected regional databases; will be further summarized using meta-analysis, where appropriate. Additional analyses (eg, stratification by gender, residency, and coadministration of other vaccines) may be performed.