Effectiveness of immunisation products against medically attended respiratory syncytial virus infection: generic protocol for a test-negative case-control study
Author:
van Roekel Caren1ORCID, Poukka Eero2ORCID, Turunen Topi2ORCID, Nohynek Hanna2, Presser Lance1ORCID, Meijer Adam1ORCID, Heikkinen Terho3ORCID, Kramer Rolf4ORCID, Begier Elizabeth5ORCID, Teirlinck Anne C1, Knol Mirjam J1, Nair Harish, Campbell Harry, Bont Louis, Meijer Adam, Teirlinck Anne C, Knol Mirjam, Gideonse David, Backx Anoek, de Melker Hester, van Roekel Caren, Presser Lance, Turunen Topi, Nohynek Hanna, Poukka Eero, Saukkoriipi Annika, Paget John, van Summeren Jojanneke, Dückers Michel, Heikkinen Terho, Audenis Berta Gumí, Llavero Maica, Kragten Leyla, Kriek Lies, Faksová Kristýna, Giardini Michele, Emborg Hanne-Dorthe, Rocchi Francesca, Quiles Cintia Muñoz, Diez-Domingo Javier, Vernhes Charlotte, Demont Clarisse, Robin Aurelie, Neveu David, Marcelon Lydie, Bangert Mathieu, Kramer Rolf, Martyn Oliver, Bardone Corinne, Remy Vanessa, Chaves Sandra, Molnar Daniel, dos Santos Gael, Pirçon Jean-Yves, Rizkalla Bishoy, Turriani Elisa, Li Se, Melegh Noemie Napsugar, Joosten Philip, Moreno Victor Preckler, Shambulova Aigul, Cheret Arnaud, Quelard Delphine, Aerssens Jeroen, Weber Karin, Willame Corinne, Puggina Anna, Theis-Nyland Katherine, Nikolayeva Natalia, Kumar Veena, Beyhaghi Hadi, Shinde Vivek, Schmoele-Thoma Beate, Begier Elizabeth, Swanson Kena, Htar Tin Tin, Atwell Jessica, Aliabadi Negar, Deese Jen, Fell Deshayne, Lino Maria Maddalena, Turiga Monica-Flavia, Ahani Bahar,
Affiliation:
1. Centre for Infectious Disease Control, National Institute for Public Health and Environment (RIVM) , 3721 MA Bilthoven , the Netherlands 2. Infectious Disease Control and Vaccinations Unit, Department of Health Security, Finnish Institute for Health and Welfare , FI-00271 Helsinki , Finland 3. Department of Pediatrics, University of Turku and Turku University Hospital , Turku , Finland 4. Sanofi Pasteur SA , 69007 Lyon , France 5. Pfizer Limited , 10017 New York City, New York , US
Abstract
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 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.
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Immunology and Allergy
Cited by
4 articles.
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