Effectiveness of Immunization Products Against Medically Attended Respiratory Syncytial Virus Infection: Generic Protocol for a Test-Negative Case-Control Study

• Published in: The Journal of infectious diseases Vol. 229; no. Supplement_1; pp. S92 - S99
• Main Authors: van Roekel, Caren, Poukka, Eero, Turunen, Topi, Nohynek, Hanna, Presser, Lance, Meijer, Adam, Heikkinen, Terho, Kramer, Rolf, Begier, Elizabeth, Teirlinck, Anne C, Knol, Mirjam J
• Format: Journal Article
• Language: English
• Published: United States Oxford University Press 01.03.2024
• Subjects: Aged; Case-Control Studies; Child; Drugs, Generic; Female; Humans; Immunization; Pregnancy; Respiratory Syncytial Virus Infections - prevention & control; Respiratory Syncytial Virus, Human; Respiratory Tract Infections; Vaccination; real-world effectiveness; vaccine; (severe) acute respiratory infection; RSV; monoclonal antibody; test-negative design study
• ISSN: 0022-1899; 1537-6613
• DOI: 10.1093/infdis/jiad483

Abstract Monitoring the real-life effectiveness of respiratory syncytial virus (RSV) products is of major public health importance. This generic protocol for a test-negative design study aims to address currently envisioned approaches for RSV prevention (monoclonal antibodies and vaccines) to study effectiveness of these products among target groups: children, older adults, and pregnant women. The generic protocol approach was chosen to allow for flexibility in adapting the protocol to a specific setting. This protocol includes severe acute respiratory infection (SARI) and acute respiratory infection (ARI), both due to RSV, as end points. These end points can be applied to studies in hospitals, primarily targeting patients with more severe disease, but also to studies in general practitioner clinics targeting ARI.