id.DRIVE (former COVIDRIVE) study of brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Case-control

Study drug and medical condition

• Medicinal product name:
  COMIRNATY

  COVID-19 VACCINE (INACTIVATED, ADJUVANTED)

  JCOVDEN

  NUVAXOVID

  VAXZEVRIA
• Medicinal product name, other:
  COVID-19 vaccine (Ad26.COV2-S [recombinant]); COVID-19 vaccine (ChAdOx1-S [recombinant])
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 MRNA VACCINE (NUCLEOSIDE-MODIFIED)

  COVID-19 VACCINE (RECOMBINANT, ADJUVANTED)

  FAMTOZINAMERAN

  RAXTOZINAMERAN

  RILTOZINAMERAN

  TOZINAMERAN
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BN) Covid-19 vaccines

  Covid-19 vaccines
• Medical condition to be studied:
  Respiratory tract infection

Population studied

• Short description of the study population:
  The study population consists of individuals (patients), presenting at the participating hospitals during the study period, who were ever eligible for COVID-19 vaccination following the national/regional immunisation recommendations prior to hospital admission AND from whom informed consent is obtained (alternative: informed consent from legally acceptable representative) AND are hospitalised (=person admitted to the hospital with overnight stay) AND meet the severe acute respiratory infection (SARI) case definition but HAVE NOT BEEN hospitalised with COVID-19 within 3 months prior to the current admission and DO NOT HAVE any contraindication for swabbing and DID NOT receive their last vaccine dose with any other than EMA-approved COVID-19 vaccine brand (EMA approval status at time of hospitalisation).
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  15000

Study design details

• Study design:
  This study is a multi-country, multi-centre, hospital-based case-control study with test-negative controls (TNCC design). ; A combination of primary and secondary data collection will be used to obtain the relevant data.
• Main study objective:
  To estimate brand-specific COVID-19 vaccine effectiveness (CVE) against hospitalisation due to laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in SARI patients who have received [vaccine dose of interest], compared to [selected comparator group].
• Setting:
  Hospitals
• Comparators:
  Unvaccinated or not recently vaccinated patients
• Outcomes:
  The outcome of interest for the primary analysis will be SARS-CoV-2 detection in patients hospitalised with SARI symptoms. ; SARS-CoV-2 infection should be laboratory-confirmed by reverse transcription polymerase chain reaction (RT-PCR) or another RNA amplification system with at least the same sensitivity as RT-PCR (e.g., transcription-mediated amplification (TMA)). ; As the SARS-CoV-2 testing practices might change over time, the test requirement for confirmation of COVID-19 disease might be revisited. The impact of such revisions on the potential for disease misclassification will be considered.
• Data analysis plan:
  A SAP is developed prior to the conduct of the analysis. ; The SAP specifies all statistical analyses conducted, and includes tables shells and mock figures.
• Summary results:
  See https://iddrive.eu/deliverables/