Effectiveness of vaccines and monoclonal antibodies against respiratory syncytial virus: Generic protocol for register-based cohort study
: Poukka Eero, van Roekel Caren, Turunen Topi, Baum Ulrike, Kramer Rolf, Begier Elizabeth, Presser Lance, Teirlinck Anne, Heikkinen Terho, Knol Mirjam, Nohynek Hanna; PROMISE Investigators
Publisher: Oxford University Press
: 2024
: Journal of Infectious Diseases
: The Journal of Infectious Diseases
: 229
: Suppl. 1
: S84
: S91
: 0022-1899
: 1537-6613
DOI: https://doi.org/10.1093/infdis/jiad484
: https://doi.org/10.1093/infdis/jiad484
Currently several immunisation products are being developed against respiratory syncytial virus (RSV) for children, pregnant females and older adults, and some products have already received authorisation. Therefore, studies to monitor the effectiveness of these products are needed in the following years. To assist researchers to conduct post-marketing studies, we developed a generic protocol for register-based cohort studies to evaluate immunisation product effectiveness against RSV-specific and non-specific outcomes. To conduct a study on the basis of this generic protocol the researchers can use any relevant databases or healthcare registers that are available at the study site.