Influenza Clinical Trial
Official title:
Immunogenicity and Safety of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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