【摘要】 目的 评价一款国产四价灭活流感病毒裂解疫苗(Quadrivalent inactivated influenza virus split vaccine, IIV4)在≥3岁人群中接种的安全性。方法 采用单中心、开放性的Ⅰ期临床试验，在贵州省某县序贯入组18-59岁、≥60岁、9-17岁和3-8岁受试者，其中≥9岁各组接种1剂IIV4,3-8岁受试者分为两组接种1剂和2剂IIV4,观察每剂接种后30d内征集性/非征集性不良事件和6个月内严重不良事件。结果 5个观察组各纳入20例受试者，共接种120剂次IIV4。征集性、非征集性不良事件总发生率分别为25.0%、30.0%,征集性不良事件主要为接种部位疼痛、肿胀和瘙痒以及疲乏、食欲减退、腹痛等全身症状。严重不良事件总发生率为1.7%,均与疫苗接种无关。结论 Ⅰ期临床试验初步显示试验疫苗IIV4在≥3岁人群中接种安全性良好。更多还原

【Abstract】 Objective To evaluate the safety of a domestic quadrivalent inactivated influenza virus split vaccine(IIV4) among people ≥3 years old.Methods We conducted a single-center, open-label, phase I clinical trial and sequentially enrolled 18-59-, ≥60-, 9-17-, and 3-8-year-olds in a county in Guizhou province. Subjects ≥9 years of age received one dose of IIV4 and subjects 3-8 years of age were randomly allocated to receive either one or two doses of IIV4. We observed for solicited and unsolicited adverse events within 30 days and serious adverse events within 6 months after each dose.Results Each of the 5 observation groups included 20 subjects; in all, 120 doses of IIV4 were administered. Overall incidences of solicited and unsolicited adverse events were 25.0% and 30.0%, respectively, most of which were injection-site pain, swelling, or pruritus, or were systemic symptoms of fatigue, loss of appetite, or stomachache. The overall incidence of serious adverse events was 1.7%, none of which were associated with the study vaccine.Conclusions This phase I clinical trial provided a safety profile of IIV4 in people ≥3 years of age.更多还原