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

(J07BM02) papillomavirus (human types 16, 18)
papillomavirus (human types 16, 18)
(J07BD52) measles, combinations with mumps and rubella, live attenuated
measles, combinations with mumps and rubella, live attenuated
(J07AM51) tetanus toxoid, combinations with diphtheria toxoid
tetanus toxoid, combinations with diphtheria toxoid
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Children (2 to < 12 years)

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 9 and 10 years of age. 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