Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(J07AL01) pneumococcus, purified polysaccharides antigen
pneumococcus, purified polysaccharides antigen
(J07CA09) diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
(J07BD52) measles, combinations with mumps and rubella, live attenuated
measles, combinations with mumps and rubella, live attenuated
(J07AH08) meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated
meningococcus A,C,Y,W-135, tetravalent purified polysaccharides antigen conjugated
(J07CA02) diphtheria-pertussis-poliomyelitis-tetanus
diphtheria-pertussis-poliomyelitis-tetanus
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Neonate
      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)

Special population of interest

Pregnant women

Estimated number of subjects

5000
Study design details

Main study objective

To investigate the presence of adverse events following immunization (AEFI) for every vaccin, within the Dutch National Immunization Programme, in children between 0 and 4 years old. In addition, we investigate the impact and course of the AEFIs as well as the risk of recurrence of AEFIs for multidose vaccines.

Outcomes

- Which AEFI's occur after each vaccination, - What is the course and impact of these AEFIs - Do AEFI's reccur after multidose vaccinations and if so, which AEFIs? - Are there any riskfactors to experience (recurring) AEFIs?

Data analysis plan

- Cross-sectional analysis on the number of experienced AEFI's per vaccin (frequencies) - Longitudinal analyses on the recurrence of AEFI's (compare frequencies for multidose vaccinations) - Regression analysis to investigate risk factors