Surveillance of Adverse Event related to childhood vaccination reported by parents

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Intensive monitoring schemes

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07) VACCINES

  VACCINES

Population studied

• Short description of the study population:
  Vaccinated children until to 15 months age.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)
• Estimated number of subjects:
  42000

Study design details

• Main study objective:
  To involve parents in the spontaneuos reporting system of Adverse Event following immunization (AEFI). Therefore to propose a routinary procedure in the local health units.
• Outcomes:
  increase of reporting rate of vaccines
• Data analysis plan:
  All AEFI reports will be introduced in the Italian Pharmacovigilance Database. All data will be evaluated in order to find potential signals.Reports from parents will be compared with reports from health operators