国产四价灭活流感病毒裂解疫苗在≥3岁人群中接种安全性的单中心Ⅰ期临床试验

Safety profile of a domestic quadrivalent split influenza virus vaccine among people≥3 years old:a single-center phase I clinical trial

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。

Objective To evaluate the safety of a domestic quadrivalent inactivated influenza virus split vaccine(IIV4)among people≥3 years old.MethodsWe 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.ResultsEach 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.ConclusionsThis phase I clinical trial provided a safety profile of IIV4 in people≥3 years of age.