The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine (TIV) in adults ≥20 and \<65 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
900
subcutaneous
subcutaneous
Unnamed facility
Kanto, Japan
Unnamed facility
Kyushu, Japan
seroconversion rate of hemagglutination inhibition (HI) antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
geometric mean titer (GMT) of HI antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
seroprotection rate of HI antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
GMT ratio of HI antibody titer (Day 29/Day 1)
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day1 and Day 29
seroconversion rate of neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
seroprotection of neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
GMT of neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
GMT ratio of neutralizing antibody titer (Day 29/Day 1)
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 1 and Day 29
Local and systemic reactions associated with the vaccination
Time frame: Day 1 through Day 8
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