A non-interventional, open observational non-inferiority study in two cluster-assigned cohorts of children aged 14 months into the safety of NeisVac-C® vaccines manufactured at two different production sites and given simultaneously with measles-mumps-rubella vaccine, assessed by web-based intensive monitoring (Peuterprik)

ENCePP Code of conduct

No

ENCePP Seal

This study has been awarded the ENCePP seal

Conflicts of interest of investigators

Declaration of interest-signed-24FEB14

Composition of steering group and observers

Steering Group and Observers Peuterprik onderzoek-5MAR14

Signed code of conduct

Annex 3 signed-24FEB14

Signed code of conduct checklist

Annex 2 signed 12Mar2014 (1)

Signed checklist for study protocols

Checklist for Study Protocol signed-24FEB14

Data sources

• Data sources (types):
  Administrative data (e.g. claims)

Use of a Common Data Model (CDM)

• CDM mapping:
  No

Data quality specifications

• Check conformance:
  Unknown
• Check completeness:
  Unknown
• Check stability:
  Unknown
• Check logical consistency:
  Unknown

Data characterisation

• Data characterisation conducted:
  Unknown