Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of pertussis and pertussis related outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children (benefit study on pertussis vaccination)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Pertussis

  Seizure

  Death

  Pneumonia bacterial

Population studied

• Short description of the study population:
  All children registered in any of the participating databases during the study period and for whom an adequate start and end of follow-up and date of birth can be defined.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)
• Estimated number of subjects:
  30000000

Study design details

• Main study objective:
  The objective of the work of the benefit pillar is to calculate incidence rates that will feed into the benefit/risk model (benefit-risk protocol).
• Outcomes:
  pertussis is the primary outcome, Secondary outcomes are complications to pertussis, such as pneumonia and seizure and death.
• Data analysis plan:
  The incidence rate of each event will be calculated using a dynamic cohort approach. When analyzing the incidence of pertussis, for each person in the cohort, follow-up time will be classified by calendar year, sex, age in months and the different risk window (see exposure section). This persontime will be the denominator for the incidence rate calculations. Incidence rates for the different outcomes will be calculated stratified by:1. database2. calendar year and month3. age in categories4. vaccination status by risk window stated above5. pertussis prior to first dose

Documents

Study results

EUPAS13766-21754