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13 results on '"Bauchau, Vincent"'

1. The Brighton collaboration standardized module for vaccine benefit-risk assessment

Author

Levitan, Bennett, primary, Hadler, Stephen C., additional, Hurst, William, additional, Izurieta, Hector S., additional, Smith, Emily R., additional, Baker, Nicole L., additional, Bauchau, Vincent, additional, Chandler, Rebecca, additional, Chen, Robert T., additional, Craig, Danielle, additional, King, Jay, additional, Pitisuttithum, Punnee, additional, Strauss, Walter, additional, Tomczyk, Sylvie, additional, Zafack, Joseline, additional, and Kochhar, Sonali, additional

Published
2023
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4. ADVANCE system testing: Benefit-risk analysis of a marketed vaccine using multi-criteria decision analysis and individual-level state transition modelling

Author

Bollaerts, Kaatje, primary, Ledent, Edouard, additional, de Smedt, Tom, additional, Weibel, Daniel, additional, Emborg, Hanne-Dorthe, additional, Danieli, Giorgia, additional, Duarte-Salles, Talita, additional, Huerta-Alvarez, Consuelo, additional, Martín-Merino, Elisa, additional, Picelli, Gino, additional, Tramontan, Lara, additional, Sturkenboom, Miriam, additional, and Bauchau, Vincent, additional

Published
2020
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5. Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines

Author

Sturkenboom, Miriam, primary, Bahri, Priya, additional, Chiucchiuini, Antonella, additional, Grove Krause, Tyra, additional, Hahné, Susan, additional, Khromava, Alena, additional, Kokki, Maarit, additional, Kramarz, Piotr, additional, Kurz, Xavier, additional, Larson, Heidi J., additional, de Lusignan, Simon, additional, Mahy, Patrick, additional, Torcel-Pagnon, Laurence, additional, Titievsky, Lina, additional, and Bauchau, Vincent, additional

Published
2020
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6. ADVANCE system testing: Can safety studies be conducted using electronic healthcare data? An example using pertussis vaccination

Author

Weibel, Daniel, primary, Dodd, Caitlin, additional, Mahaux, Olivia, additional, Haguinet, Francois, additional, De Smedt, Tom, additional, Duarte-Salles, Talita, additional, Picelli, Gino, additional, Tramontan, Lara, additional, Danieli, Giorgia, additional, Correa, Ana, additional, McGee, Chris, additional, Martín-Merino, Elisa, additional, Huerta-Alvarez, Consuelo, additional, Berencsi, Klara, additional, Emborg, Hanne-Dorthe, additional, Bollaerts, Kaatje, additional, Bauchau, Vincent, additional, Titievsky, Lina, additional, and Sturkenboom, Miriam, additional

Published
2020
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8. Safety of AS03-adjuvanted influenza vaccines: A review of the evidence

Author

Cohet, Catherine, primary, van der Most, Robbert, additional, Bauchau, Vincent, additional, Bekkat-Berkani, Rafik, additional, Doherty, T. Mark, additional, Schuind, Anne, additional, Tavares Da Silva, Fernanda, additional, Rappuoli, Rino, additional, Garçon, Nathalie, additional, and Innis, Bruce L., additional

Published
2019
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12. The Brighton collaboration standardized module for vaccine benefit-risk assessment.

Author

Levitan, Bennett, Hadler, Stephen C., Hurst, William, Izurieta, Hector S., Smith, Emily R., Baker, Nicole L., Bauchau, Vincent, Chandler, Rebecca, Chen, Robert T., Craig, Danielle, King, Jay, Pitisuttithum, Punnee, Strauss, Walter, Tomczyk, Sylvie, Zafack, Joseline, and Kochhar, Sonali

Subjects
*VACCINE development, *LOW-income countries, *TECHNOLOGY assessment, *VACCINES, *CLINICAL trials
Abstract

Vaccine Benefit-Risk (B-R) assessment consists of evaluating the benefits and risks of a vaccine and making a judgment whether the expected key benefits outweigh the potential key risks associated with its expected use. B-R supports regulatory and public health decision-making throughout the vaccine's lifecycle. In August 2021, the Brighton Collaboration's Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Benefit-Risk Assessment Module working group was established to develop a standard module to support the planning, conduct and evaluation of structured B-R assessments for vaccines from different platforms, based on data from clinical trials, post-marketing studies and real-world evidence. It enables sharing of relevant information via value trees, effects tables and graphical depictions of B-R trade-offs. It is intended to support vaccine developers, funders, regulators and policy makers in high-, middle- or low-income countries to help inform decision-making and facilitate transparent communication concerning development, licensure, deployment and other lifecycle decisions. [ABSTRACT FROM AUTHOR]

Published
2024
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13. ADVANCE: Towards near real-time monitoring of vaccination coverage, benefits and risks using European electronic health record databases.

Author

Bollaerts, Kaatje, de Smedt, Tom, McGee, Chris, Emborg, Hanne-Dorthe, Villa, Marco, Alexandridou, Maria, Duarte-Salles, Talita, Gini, Rosa, Bartolini, Claudia, de Lusignan, Simon, Tin Tin Htar, Myint, Titievsky, Lina, Sturkenboom, Miriam, and Bauchau, Vincent

Subjects
*ELECTRONIC health records, *VACCINATION of children, *VACCINE development, *WHOOPING cough vaccines, *DATABASES
Abstract

The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private partnership aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines using European electronic health record (eHR) databases. This proof-of-concept study aimed to test the feasibility of near real-time (NRT) monitoring of vaccination coverage, benefits and risks based on multiple European eHR databases, using acellular pertussis vaccination in children aged <6 years as test case. A qualitative feasibility assessment on NRT monitoring was carried out using a survey and face-to-face discussion with ADVANCE data partners. Subsequently, a dynamic cohort study was conducted containing two distinct observation periods: a first period to establish a baseline (Jan 2014 to Mar 2018) and a subsequent 3-month period to test the actual feasibility of weekly NRT monitoring, based on which data latencies were calculated. An interactive web-application was additionally developed to facilitate the visual monitoring of vaccination coverage, the vaccine preventable disease incidence rates (benefits) and the incidence rates of adverse events (risks). Nine databases from four countries (Denmark, Italy, Spain and UK) participated in the qualitative feasibility assessment. Of them, five databases took part in the dynamic cohort study, with 5 databases providing baseline data and 3 databases participating to the NRT monitoring, providing data extractions on an almost weekly basis. The median data latency (time between event date and data release date) was between 1 and 2 weeks except for the benefit and risk events in one of the databases (latency 16 weeks). Three European eHR databases successfully demonstrated the feasibility of providing data for weekly NRT monitoring, with short data latencies of 1–2 weeks for most events. [ABSTRACT FROM AUTHOR]

Published
2020
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