A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months. A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart. Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered. Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection. Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
2,772
This vaccine(0.5ml) is produced by Ab\&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection
This vaccine(0.25ml) is produced by Ab\&b Biotechnology Co., Ltd.JS。Subjects will receive two doses of quadrivalent influenza virus subunit vaccine administered 28 days apart by intramuscular injection
This vaccine(0.25ml) is produced by HUALAN BIO。Subjects will receive two doses of quadrivalent split influenza virus vaccine administered 28 days apart by intramuscular injection
Ab&b Biotechnology Co., Ltd.JS
Taizhou, Jiangsu, China
Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation
Occurrence of adverse events/reactions within 30 minutes after each dose of inoculation
Time frame: Within 30 minutes after each dose
Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation
Occurrence of adverse events/reactions within 0-7 days after each dose of inoculation
Time frame: Within 0-7 days after each dose
Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation
Occurrence of adverse events/reactions within 8-28/30 days after each dose of inoculation
Time frame: Within 8-28/30 days after each dose
Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination
Occurrence of serious adverse events within 6 months from the first dose to the full course of vaccination
Time frame: Within 6 months from the first dose to the full course of vaccination
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 28 days after full immunization
Time frame: At 28 days after full immunization
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization
The seroconversion rates ,the proportion of antibody titer ≥1:40, and the GMT at 3 months after full immunization
Time frame: At 3 months after full immunization
The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization
The seroconversion rates ,the proportion of antibody titer≥1:40, and the GMT 6 months after full immunization
Time frame: At 6 months after full immunization
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