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 elderly subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,020
subcutaneous (sc)
subcutaneous (sc)
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Unnamed facility
Kyushu, Japan
seroconversion rate of hemoagglutination 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
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 1 and Day 29
seroconversion rate of neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
seroprotection rate of neutralizing antibody titer
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
GMT of neutralizing antibody
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 29
GMT ratio of neutralizing antibody
evaluated for A/H1N1, A/H3N2, and B
Time frame: Day 1 and Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.