This is a randomized, blinded, controlled phase I clinical trial with a total of 120 participants aged ≥ 60 years. Experimental group: Influenza virus split vaccine (0.7mL/vial), control group 1: Influenza virus split vaccine, control group 2: placebo group. The three groups were recruited at a ratio of 1:1:1, and 40 individuals were randomly vaccinated in each group. Each person was injected with one dose of the vaccine into the deltoid muscle of the upper arm. Participants in each study group are required to undergo laboratory indicator tests before and on the 4th day after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each
Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each
PBS, with a specification of 0.5mL/bottle.
Danjiangkou Disease Prevention and Control Center
Wuhan, Hubei, China
RECRUITINGUnsolicited Adverse Events
Other adverse events that occurred among participants within 0-30 days after vaccination, in addition to the solicited adverse events.
Time frame: 30 days after vaccination
Solicited Adverse Events (AEs)
Adverse events defined by the protocol that occurred to the participant during 0-7 days after vaccination.
Time frame: 7 days after 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 vaccination
Seroconversion rate
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
Ratio of ≥1:40
30 days after vaccination of all participants with the experimental vaccine or control vaccines, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
Geometric mean titer (GMT)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMT of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
Geometric mean increase (GMI)
30 days after vaccination of all participants with the experimental vaccine or control vaccines, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group or the control vaccine groups.
Time frame: 30 days after vaccination
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