id.DRIVE study of brand-specific respiratory syncytial virus (RSV) vaccine effectiveness in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  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:
  ABRYSVO
• Medicinal product name, other:
  Respiratory syncytial virus vaccine (bivalent, recombinant)
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BX05) respiratory syncytial virus vaccines

  respiratory syncytial virus vaccines
• Medical condition to be studied:
  Severe acute respiratory syndrome

Population studied

• Short description of the study population:
  The study population consists of hospitalised "modified severe acute respiratory infection (SARI)"* ≥60 year-old patients. ; A "modified SARI"* patient is a person hospitalised primarily for a suspicion of a respiratory infection with at least one of the following symptoms: ; • cough, ; • shortness of breath, ; • fever (≥38 C⁰); with symptom onset within the last 10 days prior to hospital admission. ; ; *This SARI definition is modified from the latest European Centre for Disease Prevention and Control (ECDC) case definition [EUROPEAN CENTRE FOR DISEASE PREVENTION AND CONTROL (2021). ECDC Technical report: Core protocol for ECDC studies of COVID-19 vaccine effectiveness against hospitalisation with Severe Acute Respiratory Infection laboratory-confirmed with SARS-CoV-2, version 1.0, 2021].

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 RSV vaccine effectiveness (VE) against hospitalisation due to laboratory-confirmed RSV infection in severe acute respiratory infection (modified SARI) older adult patients.
• Setting:
  Hospitals
• Outcomes:
  The outcome of interest for the primary analysis will be RSV detection in patients hospitalised with symptoms consistent with the modified ECDC SARI definition. ; RSV infection must be laboratory-confirmed by reverse transcription polymerase chain reaction (RT-PCR) or another ribonucleic acid (RNA) amplification system with at least the same sensitivity as RT-PCR (e.g., transcription-mediated amplification [TMA]). RT-PCR assays must be used for the detection of at least RSV, SARS-CoV-2, and influenza. ; The secondary outcomes in patients hospitalised with modified SARI symptoms include:; • detection of RSV subtypes A and B; • detection of RSV genotypes; • modified SARI severity level of study participants (both cases and controls), including respiratory support severity level
• 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.