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.