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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
0.5 mL, Intramuscular (IM)
0.5 mL, Intramuscular (IM)
Unnamed facility
Edinburgh, United Kingdom
Unnamed facility
London, United Kingdom
Immunogenicity: To provide information concerning the immunogenicity of Influenza vaccine (split virion, inactivated).
Time frame: 21 days post vaccination
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