ADVANCE Proof-of-Concept study (POC):Testing a system for near real-time monitoring of vaccination coverage, benefits and risks in Europe with acellular pertussis vaccines as test case (ADVANCE POC: monitoring)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  System testing, testing the ADVANCE system on generating near real-time data on vaccination coverage, benefits and risks.

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Near real-time monitoring

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07AJ) Pertussis vaccines

  Pertussis vaccines

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)
• Estimated number of subjects:
  200000

Study design details

• Main study objective:
  The overall objective of the ADVANCE Proof of Concept (POC) studies is to build and test a system (including testing data availability) for benefit-risk monitoring of vaccines in Europe. Specifically, the objective of POC1.2 is to establish the feasibility of continuously and rapidly updating the information on coverage, benefits and risks using electronic healthcare and surveillance databases.
• Data analysis plan:
  The test case is near real-time (weekly or bi-weekly/monthly, depending on the database) visual monitoring of vaccination coverage, benefits and risks of pertussis vaccination. The monitoring will be facilitated through the use of an interactive dashboard developed based on the POC1 data. The dashboard contains three monitoring tabs with visualizations: - Coverage: number of administered doses per week over calendar time (extrapolated to the population of interest) and vaccination coverage (%) within specific age groups by calendar time- Benefits: observed pertussis incidence in the total population by calendar time- Risks: incidence rates in event specific risk windows and in control periods (out of risk windows) at vaccination eligible ages, separately for each risk outcome by dose, estimated cumulatively over calendar time.