To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above.
This is a single center, randomized, double-blind, controlled phase I clinical trial. Plan to include 300 participants aged 6 months and above. The experiment was divided into 5 age groups, with 60 cases each aged 6-35 months, 3-8 years, 9-17 years, 18-59 years, and ≥ 60 years old. Each age group was randomly assigned to the experimental group, control group, or placebo group in a 1:1:1 ratio. Among them, the participants aged 6 to 35 months and 3 to 8 years old will receive 2 doses throughout the entire process, with an interval of 28 days between each dose. Participants aged 9-17, 18-59, and ≥ 60 years old are vaccinated with one dose throughout the entire process.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
300
Quadrivalent influenza vaccine made from cell matrix (0.5ml/dose).
Quadrivalent influenza vaccine made from chicken embryo(0.5ml/dose).
Phosphate buffer solution without vaccine antigen(0.5ml/dose).
Shanxi Provincial Center for Disease Prevention and Control
Shanxi, China
Solicited Adverse Events (AEs)
Adverse events defined by the protocol that occurred to the participant during 0-7 days after each dose of vaccination.
Time frame: 7 days after each dose of vaccination
Unsolicited Adverse Events
Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.
Time frame: 28 or 30 days after each dose of vaccination
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame: 6 months after the last dose
Seroconversion rate
30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.
Time frame: 30 days after the last dose of vaccination
Ratio of ≥1:40
30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.
Time frame: 30 days after the last dose of vaccination
Geometric mean increase (GMI)
30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.
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Time frame: 30 days after the last dose of vaccination