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Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine

Fluart Innovative Vaccine Ltd, Hungary · 2007
ClinicalTrials.gov · Datasets · License: Public Domain · 2007
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infectioninfluenzanapreventionvaccine
This is a single blind, reference drug controlled, one center viral immunogenicity and tolerability study of FluvalAB FL-K-004 Trivalent Influenza Vaccine with 6 μg HA/strain/dos antigen content to assess immunogenicity and tolerability. The aim of the study is to assess the immunogenicity and tolerability of FluvalAB FL-K-004 trivalent influenza vaccine with 6 μg HA/strain/dos antigen content (study drug) in age groups 18-60 years and over 60 years, with the objective to verify efficacy and tolerability of the study drug according to CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997.
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