原创力文档a randomized, open-label study of the immunogenicity and reactogenicity of three lots of a combined typhoid feverhepatitis a vaccine in healthy adults：一项随机，和三批联合feverhepatitis健康成人伤寒疫苗的免疫反应原性开放标签研究.pdfVIP
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a randomized, open-label study of the immunogenicity and reactogenicity of three lots of a combined typhoid feverhepatitis a vaccine in healthy adults：一项随机，和三批联合feverhepatitis健康成人伤寒疫苗的免疫反应原性开放标签研究
CLINICAL THERAPEUTICS®/VoL.26, No. 7, 2 0 0 4
A Randomized, Open-Label Study of the Immunogenicity
and Reactogenicity of Three Lots of a Combined Typhoid
Fever/Hepatitis AVaccine in Healthy Adults
Micha Loebermann, MD, 1 Herwig Kollaritsch, MD, 2 Tom Ziegler, MD, 1
Pamela Rendi-Wagner, MD, 2 Laurent Chambonneau, MSc, 3 Rafaele Dumas, MD, 3
and Michael Lafrenz, MD 1
~Department of TropicalMedicine and Infectious Diseases, Faculty of Medicine, University of Rostoch, Germany,
2Department of Specific Prophylaxis and TropicalMedicine, Institute of Pathophysiology, University of Vienna,Austria,
and 3AventisPasteur MSD, Lyon, France
A B S T R A C T
Background: Travelers are often advised to receive both the typhoid fever and hepatitis A virus (HAV) vac-
cines, particularly when going to areas where the 2 diseases are endemic. Thus, combined administration of these
vaccines could make immunization more acceptable by reducing the number of injections needed.
Objective: This study compared the safety profiles and immunogenicity of 3 batches of a combined typhoid
fever/HAV vaccine administered using a dual-chamber bypass syringe.
Methods: This randomized, open-label study was conducted at 2 university-based travel clinics in Germany
and Austria. Subjects received a single IM injection from 1 of 3 batches of the combined vaccine. Blood samples
were drawn immediately before and 28 days after vaccination to evaluate the response to the 2 antigens by
assessing geometric mean titers (G
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