摘要
目的评价国产15价肺炎球菌结合疫苗在中国健康成人、儿童和婴幼儿中接种的安全性。方法2020年1—8月在河北省疫苗临床研究基地采用单中心、单臂试验设计,共入组100名2月龄(最小可至6周龄)以上受试者。受试者共分为5个年龄组:≥18岁组、1~5岁组、7~11月龄组、3月龄组和2月龄组(最小可至6周龄),各年龄组均为20名。≥18岁组和1~5岁组受试者接种1剂试验疫苗,7~11月龄组以0、2月程序接种2剂试验疫苗,3月龄组和2月龄组分别按0、1、2月程序和0、2、4月程序接种3剂试验疫苗。采用定期随访和主动报告相结合的方式,观察疫苗接种后30 d内的不良反应。结果≥18岁组接种1剂后有14例发生不良反应;1~5岁组有10例出现不良反应。7~11月龄组2剂接种后共有11例出现不良反应,严重程度多为轻度。2~3月龄组人群共有26例发生不良反应,发生率为65.00%(26/40),其中3月龄和2月龄发生例数分别为12例与14例;不良反应以全身反应为主,发热(57.50%,23/40)和胃肠道反应(腹泻15.00%,6/40)较多见;以轻至中度为主,多数发生在接种后7 d内且持续时间较短。结论国产15价肺炎球菌结合疫苗对各年龄组人群的安全性良好,可接受度较高。
Objective To evaluate the safety of domestically produced pneumococcal 15-valent conjugate vaccine(PCV15)in healthy adults,children and infants.Methods From January to August 2020,a single-center,single-arm trial was conducted at Hebei Clinical Vaccine Research Center,and a total of 100 subjects aged 2 months(at least 6 weeks old)or older were enrolled.The subjects were divided into five age groups:≥18 years group,1-5 years group,7-11 months group,3 months group,and 2 months(at least 6 weeks old)group,with 20 subjects in each group.Subjects in the≥18 years and 1-5 years age groups received a single dose of the experimental vaccine,and those in the 7-11 months age group received the vaccine according to a 2-dose schedule of 0,2 months.Those in the 3 months and 2 months age groups received the vaccine according to a 3-dose schedule of 0,1,2 months and 0,2,4 months,respectively.Adverse reactions within 30 days after vaccination were observed by regular follow-up and active reporting.Results After one dose of the vaccine,14 cases and 10 cases of adverse reactions occurred in≥18 years and 1-5 years age groups,respectively.After two doses,there were 11 cases showing vaccine-related mild adverse reactions in the 7-11 months age group.In the 2-3 months age group,26 cases(65.00%,26/40)of adverse reactions occurred,with the occurrence of 12 cases and 14 cases in the 3 months and 2 months age groups,respectively.Systemic reactions were the main manifestation,including fever(57.50%,23/40)and gastrointestinal reaction(diarrhea 15.00%,6/40).Adverse reactions were mainly mild to moderate,and most occurred within 7 days after vaccination and lasted for a short time.Conclusions The domestically produced pneumococcal 15-valent conjugate vaccine has good safety and high acceptability in various age groups.
作者
潘璐璐
高招
李敏捷
周卫维
信亚楠
方文建
赵颖
杜琳
赵玉良
Pan Lulu;Gao Zhao;Li Minjie;Zhou Weiwei;Xin Yanan;Fang Wenjian;Zhao Ying;Du Lin;Zhao Yuliang(Institute of Vaccine Clinical Research,Hebei Province Center for Disease Control and Prevention,Shijiazhuang 050021,China;Office of Vaccine Clinical Research,Laishui County Center for Disease Control and Prevention,Baoding 074100,China;Beijing Zhifei Lvzhu Biopharmaceutical Co.Ltd,Beijing 100176,China)
出处
《国际流行病学传染病学杂志》
CAS
2023年第5期337-341,共5页
International Journal of Epidemiology and Infectious Disease
关键词
肺炎球菌菌苗
疫苗
结合
不良事件
安全性
Pneumococcal vaccines
Vaccines,conjugate
Adverse events
Safety
