open access publication

Conference Paper, 2024

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

Journal of Infectious Diseases, ISSN 0022-1899, 1537-6613, Volume 229, Pages S92-S99, 10.1093/infdis/jiad483

Contributors

Roekel C.V. 0000-0002-1247-8103 (Corresponding author) [1] Poukka E. 0000-0001-5776-5897 [2] Turunen T. 0000-0003-3035-1584 [2] Nohynek H. [2] Presser L. 0000-0003-3610-3215 [1] Meijer A. [1] Heikkinen T. 0000-0001-6504-0116 Kramer R. 0000-0002-6095-4338 Begier E. 0000-0002-1287-5416 [3] Teirlinck A. 0000-0002-1172-8975 [1] Knol M.J. [1] Nair H. 0000-0002-9432-9100 [4] Campbell H. 0000-0002-6169-6262 [4] Bont L. [5] Meijer A. [1] Teirlinck A. 0000-0002-1172-8975 [1] Knol M.J. [1] Gideonse D. [1] Backx A. [1] de Melker H. [1] Roekel C.V. 0000-0002-1247-8103 (Corresponding author) [1] Presser L. 0000-0003-3610-3215 [1] Turunen T. 0000-0003-3035-1584 [2] Nohynek H. [2] Poukka E. 0000-0001-5776-5897 [2] Saukkoriipi A. [2] Paget J. 0000-0002-1503-2481 [6] Summeren J.V. [6] Duckers M. [6] Heikkinen T. 0000-0001-6504-0116 Audenis B.G. Llavero M. Kragten L. Kriek L. Faksova K. Giardini M. Emborg H.-D. 0000-0001-8062-0864 Rocchi F. Quiles C.M. [7] Diez-Domingo J. [7] Vernhes C. [7] Demont C. [7] Robin A. [7] Neveu D. [7] Marcelon L. [7] Bangert M. [7] Kramer R. 0000-0002-6095-4338 [7] Martyn O. [7] Bardone C. [7] Remy V. [7] Chaves S.S. 0000-0002-9453-7057 [7] Molnar D. [8] Santos G.D. [9] Pircon J.-Y. [9] Rizkalla B. [9] Turriani E. [9] Li S. [9] Melegh N.N. [9] Joosten P. 0000-0003-2948-8954 [9] Moreno V.P. [9] Shambulova A. [10] Cheret A. [10] Quelard D. [10] Aerssens J. [10] Weber K. [10] Willame C. 0000-0002-6310-6019 [10] Puggina A. [10] Theis-Nyland K. [10] Nikolaye N. [10] Kumar V. [11] Beyhaghi H. [11] Shinde V. [11] Schmoele-Thoma B. Begier E. 0000-0002-1287-5416 Swanson K. Htar T.T. Atwell J. Aliabadi N. Deese J. Fell D.B. Lino M.M. Turiga M. Ahani B. [12]

Affiliations

  1. [1] National Institute for Public Health and the Environment (RIVM)
    2. [NORA names: Netherlands; Europe, EU; OECD];
  2. [2] National Institute for Health and Welfare
    3. [NORA names: Finland; Europe, EU; Nordic; OECD];
  3. [3] Pfizer
    4. [NORA names: United States; America, North; OECD];
  4. [4] University of Edinburgh
    5. [NORA names: United Kingdom; Europe, Non-EU; OECD];
  5. [5] University Medical Center Utrecht
    6. [NORA names: Netherlands; Europe, EU; OECD];

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.

Keywords

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

Funders

  • Innovative Medicines Initiative
  • European Federation of Pharmaceutical Industries and Associations
  • Suomen Lääketieteen Säätiö
  • Horizon 2020

Data Provider: Elsevier

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