ADVANCE POC I Risk pillar - Testing new approaches to monitoring benefit/risk with pertussis vaccines as test case: Incidence rates of safety outcomes of whole-cell pertussis and acellular pertussis vaccines in pre-school children

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PERTUSSIS VACCINE
• Medical condition to be studied:
  Injection related reaction

  Somnolence

  Crying

  Convulsion in childhood

  Lip swelling

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:
  1. To evaluate participating databases on quality criteria for inclusion in the study 2. To provide incidence rates within specific risk windows after each dose of wP or aP vaccine in pre-school children and within the periods outside the risk windows (baseline) for a benefit/risk analysis model3. T
• Outcomes:
  Exposure of interestAny wP vaccines and aP pertussis-containing vaccines and their doses in the vaccine schedule (D1, D2, D3, D4, D5)Outcomes Injection site reactions: erythema, edema, induration/nodule/sterile abscess, pain/tenderness Fever Somnolence Persistent crying, irritability Generalized convulsive seizures HHE Extensive limb swelling
• Data analysis plan:
  Data Analysis: The purpose of this study is to provide incidence rates (i.e. baseline and risk-window specific) of known adverse reactions following vaccination with pertussis-containing vaccines for use in a multi-criteria decision analysis (MCDA) model of benefits and risks of wP versus aP pertussis vaccines (models are described in a separate benefit-risk study protocol). In some more recent databases, wP information will not be captured. To generate risk-window specific incidence rates for the wP period in these databases, the IR ratio originating from an SCCS analysis of wP versus baseline in other databases will be multiplied by the baseline IR.

Documents

Results tables

ADVANCE D5 6_ExecSummaryEU-PAS