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目的 评价一种无硫柳汞的国产三价流感病毒裂解疫苗 (TIV) 上市后免疫原性和安全性.方法 采用单中心、无对照设计在湖北省某乡镇招募≥6月龄健康受试者, 接种本研究TIV, 检测受试者免疫前和全程免疫后21-28d血清H1N1、H3N2、B型流感病毒血凝抑制 (HI) 抗体, 观察接种后7d内不良反应.结果591名受试者TIV免疫后H1N1、H3N2、B型流感病毒HI抗体阳转率分别为73.3％、86.3％、65.8％, 抗体几何平均滴度 (GMT) 分别比免疫前增长10.9倍、20.2倍、8.0倍, 抗体保护率分别为97.5％、100％、96.6％.720名受试者接种疫苗后总不良反应发生率为4.4％, 其中局部反应、全身反应分别为0.8％、3.6％, 未发现严重不良反应.结论 本研究TIV应用于≥6月龄人群的免疫原性和安全性良好.“,”Objective To evaluate the immunogenicity and safety of a Chinese thimerosal-free trivalent split influenza virus vaccine. Methods We used a single-center, uncontrolled design to recruit healthy subjects aged ≥6 months in a township of Hubei province. Participants were vaccinated with the study trivalent influenza vaccine (TIV). We tested for serum hemagglutination inhibition (HI) antibody against H1 N1, H3 N2, and B influenza viruses before and 21-28 days af ter vaccination. We observed adverse reactions within 7 days af ter vaccination. Results Seroconversion rates of HI antibody against H1 N1, H3 N2, and B influenza viruses were 73.3％, 86.3％, and 65.8％, respectively, among 591 subjects; antibody geometric mean titers (GMTs) af ter TIV administration were 10.9, 20.2 and 8.0 times higher than bef ore vaccination; protective antibody rates were 97.5％, 100％, and 96.6％, respectively. The overall incidence of adverse reactions was 4.4％ among 720 subjects, with 0.8％ and 3.6％ for local and systemic reactions, respectively. No serious adverse reactions were observed. Conclusions The study TIV had good immunogenicity and safety profiles in this ≥6 month old population.