The purpose of this study is to obtain immunogenicity and safety data of two different dose levels of an H5N1 pandemic influenza vaccine in a healthy Japanese adult population aged 18 to 59 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
340
Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm
Medical Co. LTA PS Clinic
Fukuoka, Fukuoka, Japan
CPC Clinic, Medipolis Medical Research Institute
Kagoshima, Kagoshima-ken, Japan
Osaka Pharmacology Clinical Research Hospital
Osaka, Osaka, Japan
Number of subjects with antibody response to the vaccine strain
Measurement by single radial hemolysis (SRH) assay
Time frame: 21 days after 2nd vaccination
Number of subjects demonstrating seroconversion
Measurement by SRH assay
Time frame: 21 days after 2nd vaccination
Fold increase of antibody response
Measurement by SRH assay
Time frame: 21 days after 2nd vaccination
Number of subjects with antibody response to the vaccine strain
Measurement by SRH (except at 21 days after 2nd vaccination), microneutralization (MN) and hemagglutination inhibition (HI) assay
Time frame: 21 days after 1st and 21+180 days after 2nd vaccination
Number of subjects demonstrating seroconversion
Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay
Time frame: 21 days after 1st and 21+180 days after 2nd vaccination
Antibody response
Measurement by SRH, MN and HI assay
Time frame: 21 days after 1st and 21 + 180 days after 2nd vaccination
Fold increase of antibody response
Measurement by SRH (except at 21 days after 2nd vaccination), MN and HI assay
Time frame: 21 days after 1st and 21+180 days after 2nd vaccination as compared to baseline
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