Krubiner, Carleigh B Faden, Ruth R Karron, Ruth A Little, Margaret O Lyerly, Anne D Abramson, Jon S Beigi, Richard H Cravioto, Alejandro R Durbin, Anna P Gellin, Bruce G
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Published in
Vaccine
Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely - and at times uniquely - affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response...
Shearer, Jeffry D Henning, Lisa Sanford, Daniel C Li, Na Skiadopoulos, Mario H Reece, Joshua J Ionin, Boris Savransky, Vladimir
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Vaccine
The anthrax vaccine candidate AV7909 is being developed as a next-generation vaccine for post-exposure prophylaxis (PEP) against inhalational anthrax. In clinical studies, two vaccinations with AV7909 administered either two or four weeks apart induced an enhanced immune response compared to BioThrax® (Anthrax Vaccine Adsorbed) (AVA). Anthrax toxin...
Ohfuji, Satoko Okada, Kenji Mouri, Yoko Mihara, Yuka Ishii, Shigeki Miyata, Akiko Fujino, Motoko Motomura, Chikako Ito, Hiroaki Ohta, Mitsuhiro
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Published in
Vaccine
The Japanese national immunization program recommends that children receive 4 doses of acellular pertussis vaccine between 3 months and 2 years of age. Nevertheless, the number of pertussis cases is increasing in elementary school children aged 6-12 years. Therefore, a test-negative case-control study was conducted to assess the effectiveness of th...
Sturkenboom, Miriam Bahri, Priya Chiucchiuini, Antonella Grove Krause, Tyra Hahné, Susan Khromava, Alena Kokki, Maarit Kramarz, Piotr Kurz, Xavier Larson, Heidi J
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Published in
Vaccine
The influenza A/H1N1 pandemic in 2009 taught us that the monitoring of vaccine benefits and risks in Europe had potential for improvement if different public and private stakeholders would collaborate better (public health institutes (PHIs), regulatory authorities, research institutes, vaccine manufacturers). The Innovative Medicines Initiative (IM...
Bollaerts, Kaatje Ledent, Edouard de Smedt, Tom Weibel, Daniel Emborg, Hanne-Dorthe Danieli, Giorgia Duarte-Salles, Talita Huerta-Alvarez, Consuelo Martín-Merino, Elisa Picelli, Gino
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Published in
Vaccine
The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines using electronic health record (eHR) databases in Europe. Proof-of-concept studies were designed to assess the proposed processes and system f...
Bollaerts, Kaatje de Smedt, Tom McGee, Chris Emborg, Hanne-Dorthe Villa, Marco Alexandridou, Maria Duarte-Salles, Talita Gini, Rosa Bartolini, Claudia de Lusignan, Simon
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Published in
Vaccine
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) monit...
Tin Tin Htar, Myint de Ridder, Maria Braeye, Toon Correa, Ana McGee, Chris de Lusignan, Simon Duarte-Salles, Talita Huerta-Alvarez, Consuelo Martín-Merino, Elisa Tramontan, Lara
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Published in
Vaccine
The Accelerated Development of VAccine benefit-risk Collaboration in Europe (ADVANCE), a public-private consortium, implemented and tested a distributed network system for the generation of evidence on the benefits-risks of marketed vaccines in Europe. We tested the system by estimating the incidence rate (IR) of pertussis and pertussis-related com...
Weibel, Daniel Dodd, Caitlin Mahaux, Olivia Haguinet, Francois De Smedt, Tom Duarte-Salles, Talita Picelli, Gino Tramontan, Lara Danieli, Giorgia Correa, Ana
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Published in
Vaccine
The Accelerated Development of Vaccine benefit-risk Collaboration in Europe (ADVANCE) public-private collaboration, aimed to develop and test a system for rapid benefit-risk monitoring of vaccines using healthcare databases in Europe. The objective of this proof-of-concept (POC) study was to test the feasibility of the ADVANCE system to generate in...
Gini, Rosa Dodd, Caitlin N Bollaerts, Kaatje Bartolini, Claudia Roberto, Giuseppe Huerta-Alvarez, Consuelo Martín-Merino, Elisa Duarte-Salles, Talita Picelli, Gino Tramontan, Lara
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Published in
Vaccine
The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines using European healthcare databases. Event misclassification can result in biased estimates. Using different algorithms for identifying cases ...
Emborg, Hanne-Dorthe Kahlert, Johnny Braeye, Toon Bauwens, Jorgen Bollaerts, Kaatje Danieli, Giorgia Duarte-Salles, Talita Glismann, Steffen Huerta-Alvarez, Consuelo de Lusignan, Simon
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Published in
Vaccine
The Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) is a public-private collaboration aiming to develop and test a system for rapid benefit-risk (B/R) monitoring of vaccines, using existing healthcare databases in Europe. The objective of this paper was to assess the feasibility of using electronic healthcare datab...