Register-based RWE and pragmatic vaccine studies in Finland

Scientific study examining the burden of pneumococcal disease in Finland during the current infant pneumococcal vaccination programme (10-valent pneumococcal conjugate vaccine, PCV10). The study uses data from national health registers.

Meningitis is a rare but serious illness caused by various bacteria. This study describes every meningitis case in Finland during 1995–2022, with special attention to diseases caused by Neisseria meningitidis. Invasive meningococcal disease (IMD) can be fatal and may lead to significant physical, psychological, and social sequelae. No comprehensive study on the long-term effects of IMD has previously been conducted in Finland.

A population-based national register study on pertussis in children under 14 years of age in Finland, 1995–2019. It assesses the effectiveness of the pertussis vaccine given at preschool age in a cohort design, taking previous vaccinations and time since vaccination into account. The impact of the preschool booster is also evaluated by comparing the temporal incidence of pertussis according to whether that dose was included in the vaccination programme or not. Incidence is further analysed by age, period, geographic area, vaccination status and hospitalisation.

Scientific study assessing the effectiveness of the COVID-19 vaccine (Pfizer-BioNTech) against severe disease among people aged 65 years and older, and among people aged 12 years and older who are susceptible to severe COVID-19 because of an underlying condition or medication, in Finland. The study uses data from national health registers.

This medical study aims to describe the current prevalence of pneumococcal nasopharyngeal carriage and serotype distribution in young children in Finland. Complementary baseline information is collected from health registers for the study subjects.
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‍FVR has specialised expertise in phase 4 clinical vaccine trials that make use of national register data. In these large field studies (so-called pragmatic trials) the goal is to employ the optimal design - randomised controlled trials - so that study quality is high and the results are straightforward to interpret. Large clinical vaccine trials are difficult to run, demand meticulous follow-up and significant professional manpower, and are therefore costly.

Using national health registers for participant follow-up, however, greatly reduces expenses and makes even extensive trials feasible. In pragmatic studies, participant recruitment and vaccination procedures are often carried out in collaboration with existing healthcare organizations, following routine clinical practices as closely as possible. This approach enhances the feasibility of the study and improves the generalizability of the findings to real-world settings.

A research team experienced in pragmatic studies transferred to FVR from the Finnish Institute for Health and Welfare (THL). THL has completed two large pragmatic phase 4 field studies:

1. FinIP vaccine study (2008–2018), conducted in collaboration with GSK (GlaxoSmithKline). It remains the largest pneumococcal vaccine study ever performed in children, involving more than 47 000 participants across Finland.
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2. FinFluHD influenza vaccine study (2018–2022), conducted with Sanofi Pasteur. During the 2019–2020 influenza season it enrolled over 33 000 participants, but the coronavirus pandemic led to a pause and termination in spring 2022.