Vaccine Effectiveness, Burden and Impact Studies (VEBIS) - Vaccine effectiveness hospital admission with Severe Acute Respiratory Infection

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000099
• EU PAS number:
  EUPAS1000000099
• Study ID:
  1000000099
• Official title and acronym:
  Vaccine Effectiveness, Burden and Impact Studies (VEBIS) - Vaccine effectiveness hospital admission with Severe Acute Respiratory Infection
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Croatia

  Czechia

  Hungary

  Ireland

  Lithuania

  Luxembourg

  Malta

  Portugal

  Romania

  Spain
• Study description:
  This is a multi-country hospital-based study of vaccine effectiveness against hospitalisation with Severe Acute Respiratory Infection laboratory-confirmed with SARS-CoV-2 or with influenza.; ; This is a case-control study using a test negative design. The study population consists of individuals of all ages, belonging to the target group for COVID-19 or influenza vaccination, hospitalised with SARI symptoms and no contra-indication for being vaccinated with the vaccine of interest. The study period runs during the influenza circulation season for influenza vaccine effectiveness study.
• Study status:
  Ongoing

Research institutions and networks

Institutions

European Centre for Disease Prevention and Control

EpiConcept

Study timelines

Date when funding contract was signed

Actual: 13/10/2021

Study start date

Actual: 01/12/2021

Date of final study report

Planned: 31/10/2025

Sources of funding

Other

More details on funding

Funded by European Centre for Disease Prevention and Control

Study protocol

Initial protocol

covid-19-vaccine-effectiveness-sari-protocol-version-2.pdf

Regulatory

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