This study is designed to generate clinical data as outlined in the Note for Guidance on harmonization requirements for influenza vaccine marketing authorization by the European Medicines Agency. The objectives of the trial are: * To determine immunogenicity, of the inactivated, split-virion influenza vaccine Northern Hemisphere (NH) 2007-2008 formulation in terms of the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96. * To describe the safety of the inactivated, split-virion influenza vaccine, NH 2007-2008 formulation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
130
0.5 mL, Intramuscular
Unnamed facility
Edinburgh, United Kingdom
Unnamed facility
London, United Kingdom
To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated).
Time frame: 21 Days post-vaccination
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