To evaluate the safety and immunogenicity of the three consecutive lots of an seasonal split influenza vaccine Anflu in adults, a randomized, double-blind and controlled clinical trial was conducted in 560 subjects in Tianjin City of China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
566
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime
Haemagglutination-inhibition (HI) antibody titer of influenza A H1N1, influenza A H3N2 and influenza B
Time frame: 0, 21 days
local and systematic adverse reactions after vaccination
Time frame: within 3 days after vaccination
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0.5 ml/dose, containing 45 μg influenza HA antigens, 15 μg each subtype; one dose regime