Effectiveness of immunisation products against medically attended respiratory syncytial virus infection: generic protocol for a test-negative case-control study

: 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; PROMISE investigators

Publisher: Oxford University Press

: 2024

: Journal of Infectious Diseases

: The Journal of Infectious Diseases

: 229

: Suppl. 1

: S92

: S99

: 0022-1899

: 1537-6613

DOI: https://doi.org/10.1093/infdis/jiad483

: https://doi.org/10.1093/infdis/jiad483

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 endpoints. These endpoints can be applied to studies in hospitals, primarily targeting patients with more severe disease, but also to studies in general practitioner clinics targeting ARI.