ADVANCE POC Study Protocol - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case. Coverage rates of acellular and whole-cell pertussis-containing vaccines in preschool children (ADVANCE Coverage POC)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Coverage study
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective population based cohort study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PERTUSSIS VACCINE

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:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)
• Estimated number of subjects:
  10000000

Study design details

• Main study objective:
  To estimate the coverage of pertussis-containing vaccines in children less than 6 years of age. The specific objective of this study is to assess the system capability to estimate acellular pertussis and whole-cell pertussis vaccine coverage
• Outcomes:
  Coverage rate overall and for wP and aP vaccines is the proportion of vaccinated children by database, birth cohort, age in months and per dose The variability of vaccine administration is defined as the time elapsed between birth and the first dose and the time elapsed between subsequent scheduled doses.Changes of coverage rates over time will be described by general descriptive statistic
• Data analysis plan:
  • The coverage by age in months per birth cohort will be calculated using a Kaplan-Meier method. The proportion of vaccinated children with dose 1, 2, 3, and subsequent boosters will be calculated stratified by year of birth, type of vaccine and database.• The change of coverage rates over time will be calculated by the difference between coverage rates and a defined threshold. Low coverage thresholds will be determined for identification of variability of interest/concern. Data-driven thresholds will be compared with set values based on coverage rates required for herd immunity. CUSUM involves the calculation of a cumulative sum (which is what makes it ‘sequential’). It is designed to detect changes in the difference. It differs from Sequential Probability Ratio Test (SPRT) by always using zero function as the lower ‘holding barrier’. Also, CUSUM does not require the use of the likelihood function.

Documents

Study results

EUPAS13908-21740