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Double Blind, Multi-Center, Phase 1 Study of a Vero Cell-Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Subjects Aged 18 to 45 Years
Authors not listed
Alachua Government Services, Inc. · 2008
Abstract
The objectives of this study are to assess the dose-related safety and immunogenicity of six different dose levels of inactivated, Vero cell-derived reverse genetic reassortant A/H5N1/Indonesia/05/2005 influenza vaccine in a healthy young adult population. Subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Blood will be drawn from all subjects for serum antibody determination on Days 0, 21, 42 and 180. Body temperature will be measured daily for 6 days following vaccination. Injection site reactions and systemic reactions will be monitored throughout the entire 180 days of the study. Safety data obtained at 7 days after the first vaccination for all dose levels in Cohort 1 will be reviewed by a Data Monitoring Committee and a recommendation will be obtained whether to proceed to the second vaccination of Cohort 1 and to the first vaccination of Cohort 2.
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APA
Anonymous. (2008). Double Blind, Multi-Center, Phase 1 Study of a Vero Cell-Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Subjects Aged 18 to 45 Years. <em>Alachua Government Services, Inc.</em>. https://clinicaltrials.gov/study/NCT00783926
Vancouver
Anonymous. Double Blind, Multi-Center, Phase 1 Study of a Vero Cell-Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Subjects Aged 18 to 45 Years. Alachua Government Services, Inc.. 2008.
BibTeX
@misc{anon2008Double,
title = {Double Blind, Multi-Center, Phase 1 Study of a Vero Cell-Derived, Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Subjects Aged 18 to 45 Years},
author = {Anonymous},
journal = {Alachua Government Services, Inc.},
year = {2008},
}
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