Literature DB >> 19056451

Guidelines for collection, analysis and presentation of vaccine safety data in pre- and post-licensure clinical studies.

Jan Bonhoeffer1, Adwoa Bentsi-Enchill, Robert T Chen, Margaret C Fisher, Michael S Gold, Katharina Hartman, Ulrich Heininger, Bernard Hoet, Thomas Jefferson, Najwa Khuri-Bulos, Katrin S Kohl, S Michael Marcy, David Nalin, Robert Pless, Hernan Sanabria-Rojas, Karen Sleeman, Robert Wise.   

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Year:  2008        PMID： 19056451     DOI： 10.1016/j.vaccine.2008.11.036

Source DB:  PubMed          Journal:  Vaccine        ISSN： 0264-410X            Impact factor:   3.641


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  14 in total

Review 1.  Autoimmune/inflammatory syndrome induced by adjuvants (ASIA): clues and pitfalls in the pediatric background.

Authors:  Susanna Esposito; Elisabetta Prada; Maria Vincenza Mastrolia; Giusyda Tarantino; Claudio Codecà; Donato Rigante
Journal:  Immunol Res       Date:  2014-12       Impact factor: 2.829

2.  Consumer reporting of adverse events following immunization.

Authors:  Hazel J Clothier; Gowri Selvaraj; Mee Lee Easton; Georgina Lewis; Nigel W Crawford; Jim P Buttery
Journal:  Hum Vaccin Immunother       Date:  2014       Impact factor: 3.452

3.  Template protocol for clinical trials investigating vaccines--focus on safety elements.

Authors:  Jan Bonhoeffer; Egeruan B Imoukhuede; Grace Aldrovandi; Novilia S Bachtiar; Eng-Soon Chan; Soju Chang; Robert T Chen; Rohini Fernandopulle; Karen L Goldenthal; James D Heffelfinger; Shah Hossain; Indira Jevaji; Ali Khamesipour; Sonali Kochhar; Mamodikoe Makhene; Elissa Malkin; David Nalin; Rebecca Prevots; Ranjan Ramasamy; Sarah Sellers; Johan Vekemans; Kenneth B Walker; Pam Wilson; Virginia Wong; Khalequz Zaman; Ulrich Heininger
Journal:  Vaccine       Date:  2013-03-13       Impact factor: 3.641

4.  The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG).

Authors:  Robert T Chen; Baevin Carbery; Lisa Mac; Kenneth I Berns; Louisa Chapman; Richard C Condit; Jean-Louis Excler; Marc Gurwith; Michael Hendry; Arifa S Khan; Najwa Khuri-Bulos; Bettina Klug; James S Robertson; Stephen J Seligman; Rebecca Sheets; Anna-Lise Williamson
Journal:  Vaccine       Date:  2014-10-08       Impact factor: 3.641

5.  Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women.

Authors:  Christine E Jones; Flor M Munoz; Hans M L Spiegel; Ulrich Heininger; Patrick L F Zuber; Kathryn M Edwards; Philipp Lambach; Pieter Neels; Katrin S Kohl; Jane Gidudu; Steven Hirschfeld; James M Oleske; Najwa Khuri-Bulos; Jorgen Bauwens; Linda O Eckert; Sonali Kochhar; Jan Bonhoeffer; Paul T Heath
Journal:  Vaccine       Date:  2016-07-29       Impact factor: 3.641

6.  Needle size for vaccination procedures in children and adolescents.

Authors:  Paul V Beirne; Sarah Hennessy; Sharon L Cadogan; Frances Shiely; Tony Fitzgerald; Fiona MacLeod
Journal:  Cochrane Database Syst Rev       Date:  2018-08-09

7.  Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwp-HepB-Hib vaccine in healthy Indian toddlers and infants.

Authors:  Dulari J Gandhi; Sangappa M Dhaded; Mandyam D Ravi; Anand P Dubey; Ritabrata Kundu; Sanjay K Lalwani; Jugesh Chhatwal; Leni G Mathew; Madhu Gupta; Shiv D Sharma; Sandeep B Bavdekar; Midde V Jayanth; Suresh Ravinuthala; Arijit Sil; Mandeep S Dhingra
Journal:  Hum Vaccin Immunother       Date:  2015-11-18       Impact factor: 3.452

Review 8.  TBVAC2020: Advancing Tuberculosis Vaccines from Discovery to Clinical Development.

Authors:  Stefan H E Kaufmann; Hazel M Dockrell; Nick Drager; Mei Mei Ho; Helen McShane; Olivier Neyrolles; Tom H M Ottenhoff; Brij Patel; Danielle Roordink; François Spertini; Steffen Stenger; Jelle Thole; Frank A W Verreck; Ann Williams
Journal:  Front Immunol       Date:  2017-10-04       Impact factor: 7.561

Review 9.  The clinical development process for a novel preventive vaccine: An overview.

Authors:  K Singh; S Mehta
Journal:  J Postgrad Med       Date:  2016 Jan-Mar       Impact factor: 1.476

Review 10.  The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.

Authors:  Sonali Kochhar; Denny Kim; Jean-Louis Excler; Richard C Condit; James S Robertson; Stephen Drew; Mike Whelan; David Wood; Patricia E Fast; Marc Gurwith; Bettina Klug; Najwa Khuri-Bulos; Emily R Smith; Robert T Chen
Journal:  Vaccine       Date:  2020-07-09       Impact factor: 3.641
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