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Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation

Sanofi Pasteur, a Sanofi Company · 2008
ClinicalTrials.gov · Datasets · License: Public Domain · 2008
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influenza
This study is for a new marketing authorization application for the seasonal vaccine strains in compliance with the Note for Guidance (NfG) on harmonization requirements for influenza vaccine from the Committee for Human Medicinal Products (CHMP) Objectives: * To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine NH 2008-2009 formulation with the requirements of the CHMP NfG CPMP/BWP/214/96. * To describe the safety of the inactivated, split-virion influenza vaccine, NH 2008-2009 formulation.
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