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

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

Tekijät: 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

Kustantaja: Oxford University Press

Julkaisuvuosi: 2024

Journal: Journal of Infectious Diseases

Tietokannassa oleva lehden nimi: The Journal of Infectious Diseases

Vuosikerta: 229

Numero: Suppl. 1

Aloitussivu: S92

Lopetussivu: S99

ISSN: 0022-1899

eISSN: 1537-6613

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

Verkko-osoite: https://doi.org/10.1093/infdis/jiad483

Tiivistelmä

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.