Use of real-world data for HPV vaccine trial follow-up in the Nordic region

Post-marketing studies are commonly performed to follow-up on the safety and effectiveness of a drug or vaccine after approval has been obtained. These post-marketing studies may involve the collection of real-world data from registries and clinical biobanks in order to obtain real-world evidence. As this approach can monitor the effects of pharmaceutical products over decades, it is particularly necessary for the development of safe and effective vaccines. A long-term follow-up (LTFU) study was initiated as an extension of a phase 3 clinical study (V501 –015; NCT00092534) to assess the effectiveness, immunogenicity and safety of the quadrivalent human papillomavirus (qHPV) vaccine for up to 14 years after the start of vaccination.

Source: Contemporary Clinical Trials - March 31, 2020 Category: Radiology Authors: Espen Enerly, Sophie Berger, Susanne K. Kj ær, Karin Sundström, Suzanne Campbell, Laufey Tryggvadóttir, Christian Munk, Maria Hortlund, Thomas Group, Amita Joshi, Alfred J. Saah, Mari Nygård Source Type: research