Evaluation of vaccination error cases with fatal outcome reported to EudraVigilance

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/27849
• EU PAS number:
  EUPAS25265
• Study ID:
  27849
• Official title and acronym:
  Evaluation of vaccination error cases with fatal outcome reported to EudraVigilance
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This study will be a case-series analysis with the aim to review ICSRs reporting vaccination errors with fatal outcome as reported in EudraVigilance. Causality of the vaccine with regards to the fatal outcome will be assessed using the WHO tool for causality assessment of AEFI. The case review will be performed by two independent reviewers, who will also estimate the contribution of the vaccination error to the fatal outcome.
• Study status:
  Planned

Research institution and networks

Institutions

Department of Medical Informatics - Health Data Science, Erasmus Medical Center (ErasmusMC)

Netherlands

Medicines Evaluation Board Utrecht, Netherlands

Study timelines

Date when funding contract was signed

Planned: 01/12/2015

Study start date

Planned: 01/01/2001

Date of final study report

Planned: 30/06/2019

Sources of funding

Other

More details on funding

Erasmus Medical Center

Study protocol

Initial protocol

Study protocol_Fatal vaccination errors_v3.2_20180815

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable