An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)

Study identification

• EU PAS number:
  EUPAS45362
• Study ID:
  48839
• Official title and acronym:
  An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Netherlands

  Spain
• Study description:
  Observational Study, Retrospective observational study using electronic health care databases of various types in Europe. This study has 2 chronologically consecutive aims: 1) to conduct a feasibility assessment aiming to inform the safety evaluation study and 2) to assess the risk of developing pre-specified and newly identified AESIs following administration of Ad26.COV2.S.
• Study status:
  Finalised

Research institutions and networks

Institutions

University Medical Center Utrecht (UMCU)

Netherlands

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

The Foundation for the Promotion of Health and Biomedical Research of Valencia Region (FISABIO)

Spain

Teamit Institute

Spain

Networks

Vaccine monitoring Collaboration for Europe (VAC4EU)

Belgium

Denmark

Finland

France

Germany

Italy

Netherlands

Norway

Spain

United Kingdom

Study timelines

Date when funding contract was signed

Planned:28/02/2022

Actual:21/04/2022

Study start date

Planned:21/05/2022

Actual:23/05/2022

Date of final study report

Planned:07/03/2025

Actual:07/02/2025

Sources of funding

Other

More details on funding

Janssen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)