This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season formulation of intradermal (ID) influenza vaccine as part of a post registration commitment. Objectives: * For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 * For all groups, to describe the safety
All participants will receive a single dose of study vaccine on Day 0. Immunogenicity data will be collected before vaccination and on Day 21 post vaccination. Safety will be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
Single dose 0.1 mL, intradermal
Single dose 0.5 mL, intramuscular
Single dose 0.1 mL, intradermal
Single dose 0.5 mL, intramuscular
Unnamed facility
Seoul, South Korea
Unnamed facility
Seoul, South Korea
Information concerning the immunogenicity of intradermal influenza vaccine in terms of seroprotection status (titers ≥40) using the Hemagglutination Inhibition (HAI) technique.
Time frame: 21 days post-vaccination
Information regarding the safety (in terms of solicited injection site and systemic reactions) post-vaccination
Time frame: Day 0 to up to 21 days post-vaccination
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