Immunogenicity and safety of a quadrivalent influenza inactivated vaccine(split-virion)in a susceptible population 9-59 years of age:a phase Ⅳ clinical trial
Objective To evaluate immunogenicity and safety of a quadrivalent influenza inactivated vaccine(split-virion)(IIV4)in a susceptible population aged 9-59 years.Methods We recruited healthy individuals aged 9-59 years in a prefecture of Guizhou province to administer one dose of IIV4 to each subject.We tested sera for haemagglutination inhibition(HI)antibodies against A(H1N1),A(H3N2),BV,and BY subtypes of influenza virus before and 28 days after vaccination.We analyzed seroconversion rates,geometric mean titers(GMT),and incidences of adverse events 0-28 days after vaccination among subjects who were negative to antibodies against any subtype of influenza virus(titer＜1∶10)before vaccination.Results Seroconversion rates of HI antibody against A(H1N1),A(H3N2),BV,and BY influenza viruses after one dose of IIV4 were 93.00％(332/357),86.32％(303/351),89.64％(545/608),and 100％(8/8),respectively(95％Cis:89.84％-95.42％,82.28％-89.74％,86.94％-91.95％,and 63.06％-100％),with GMTs(1:)being 267.65,100.59,81.94,and 113.14,which were 53.53,20.12,16.39,and 22.63 times GMTs before vaccination.The incidence of vaccination-associated adverse events was 10.95％(96/877),with 6.50％local adverse events(mainly injection-site pain and pruritus)and 5.59％systemic adverse events(mainly fever and cough).Incidences for grade 1,2,and 3 adverse events were 7.98％,1.82％,and 1.14％;no grade 4 or serious adverse events occurred.Conclusion The clinical trial showed that IIV had good safety and immunogenicity profiles among susceptible individuals aged 9-59 years.
万方数据
维普
