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

Caren Van Roekel, Eero Poukka, Topi Turunen, Hanna Nohynek, Lance Presser, Adam Meijer, Terho Heikkinen, Rolf Kramer, Elizabeth Begier, Anne C. Teirlinck, Mirjam Knol, Louis Bont,

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)S92-S99
JournalJournal of Infectious Diseases
Volume229
DOIs
Publication statusPublished - 15 Mar 2024

Keywords

  • (severe) acute respiratory infection
  • monoclonal antibody
  • real-world effectiveness
  • RSV
  • test-negative design study
  • vaccine

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