Immune thrombocytopenia following vaccination with DTaP-IPV or TdaP-IPV in children

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104291
• EU PAS number:
  EUPAS104290
• Study ID:
  104291
• Official title and acronym:
  Immune thrombocytopenia following vaccination with DTaP-IPV or TdaP-IPV in children
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  United Kingdom
• Study description:
  A cohort study to generate estimates on the use of combined diphtheria / tetanus / pertussis (acellular, component) / poliomyelitis (inactivated) vaccines (DTaP-IPV or TdaP-IPV) in the general population, and incidence rates for of immune thrombocytopenia in the general population and in the population exposed to the above vaccines, across three European databases
• Study status:
  Finalised

Research institution and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 04/07/2022

Actual: 04/07/2022

Study start date

Planned: 04/07/2022

Actual: 04/07/2022

Date of final study report

Planned: 02/09/2022

Actual: 07/09/2022

Sources of funding

EMA

Study protocol

Initial protocol

Analysis Plan_Immune thrompocitopenia 202207_for publication_CLEAN

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable