Safety and immunogenicity of a quadrivalent influenza virus subunit vaccine in a healthy population ≥65 years of age:a randomized,blinded,controlled,non-inferiority phase Ⅲ clinical trial
Objective To evaluate the safety and immunogenicity of a quadrivalent influenza virus subunit vaccine in healthy individuals aged ≥ 65 years.Methods We conducted a randomized,blinded,controlled,non-inferiority clinical trial and recruited healthy ≥65-year-olds from two districts/counties of Henan province.Subjects were assigned at random to receive either one dose of the test vaccine or a licensed quadrivalent split-virus inactivated influenza vaccine(control vaccine).We observed for adverse reactions within 30 days and serious adverse events within 6 months after vaccination to determine incidence rates.We tested sera for hemagglutination inhibition antibodies against A(H1N1),A(H3N2),BV,and BY influenza viruses before and after vaccination to determine seroconversion rates and geometric mean titer(GMT)increases.Results Adverse reaction incidences for the test and control vaccines were 7.00％(28/400,95％CI:4.70％-9.96％)and 5.25％(21/400,95％CI:3.28％-7.91％),respectively;all reactions occurred within 7 days after vaccination,with no grade 4 or severe adverse reactions.Seroconversion rates of antibodies against A(H1N1),A(H3N2),BV,and BY influenza viruses after vaccination were 78.99％(312/395),87.85％(347/395),82.03％(324/395),and 79.24％(313/395)for the test vaccine,with differences(95％CI)of 5.69(-0.24-11.61),2.46(-2.28-7.20),5.70(0.06-11.34),and 5.94(0.03-11.85)percentage points higher compared with the control vaccine.GMTs(1:)of antibodies against the four types of influenza virus after vaccination were 314.43,331.43,134.96,and 305.19 for the test vaccine,with ratios(95％CI)of 1.10(0.93-1.31),1.21(1.03-1.43),1.14(0.97-1.35),and 1.28(1.06-1.53)compared with the control vaccine,and were 13.88,13.98,10.19,and 7.62 times higher than before vaccination.Conclusions The test influenza vaccine showed a good profile of safety and immunogenicity in healthy individuals aged ≥ 65 years and was non-inferior to the control influenza vaccine.
Quadrivalent influenza virus subunit vaccineSafetyImmunogenicityClinical trial≥ 65-year-old population
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