Study type

Study topic

Disease /health condition

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

Name of medicine

ABRYSVO

Name of medicine, 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.