safety, immunogenicity and dose ranging of a new vi-crm197 conjugate vaccine against typhoid fever randomized clinical testing in healthy adults安全、免疫原性和剂量范围的新vi-crm197共轭伤寒疫苗随机临床试验在健康成年人.pdfVIP

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2017-09-09 发布于上海
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safety, immunogenicity and dose ranging of a new vi-crm197 conjugate vaccine against typhoid fever randomized clinical testing in healthy adults安全、免疫原性和剂量范围的新vi-crm197共轭伤寒疫苗随机临床试验在健康成年人.pdf

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safety, immunogenicity and dose ranging of a new vi-crm197 conjugate vaccine against typhoid fever randomized clinical testing in healthy adults安全、免疫原性和剂量范围的新vi-crm197共轭伤寒疫苗随机临床试验在健康成年人

Safety, Immunogenicity and Dose Ranging of a New Vi- CRM197 Conjugate Vaccine against Typhoid Fever: Randomized Clinical Testing in Healthy Adults 1 1 2 2 3 Pierre van Damme , Froukje Kafeja , Alessandra Anemona , Venere Basile , Anne Katrin Hilbert , Ilse De 1 2 2 2 2 2 Coster , Simona Rondini , Francesca Micoli , Rana M. Qasim Khan , Elisa Marchetti , Vito Di Cioccio , 2 2 2 Allan Saul , Laura B. Martin , Audino Podda * 1 Center for the Evaluation of Vaccination, Vaccine Infectious Disease Institute, University of Antwerp, Antwerp, Belgium, 2 Novartis Vaccines Institute for Global Health, Siena, Italy, 3 Novartis Vaccines Diagnostics, Clinical Serology Laboratories, Marburg, Germany Abstract Background: Typhoid fever causes more than 21 million cases of disease and 200,000 deaths yearly worldwide, with more than 90% of the disease burden being reported from Asia. Epidemiological data show high disease incidence in young children and suggest that immunization programs should target children below two years of age: this is not possible with available vaccines. The Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM197) for infant vaccination concomitantly with EPI vaccines, either starting at 6 weeks with DTP or at 9 months with measles vaccine. We report the results from a Phase 1 and a Phase 2 dose ranging trial with Vi-CRM197 in European adults. Methodology: Following randomized blinded comparison of single vaccination with either Vi-CRM197 or licensed p