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Comparison of the Immunogenicity and Safety of Three Enhanced Inactivated Poliovirus Vaccines from Different Manufacturers in Healthy Korean Infants: A Prospective Multicenter Study

机译:来自不同制造商的三种增强型灭活脊髓灰质炎疫苗在健康韩国婴儿中的免疫原性和安全性比较:前瞻性多中心研究

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摘要

The enhanced inactivated poliovirus vaccine was first introduced in 2002, and several inactivated poliovirus vaccines are licensed in Korea. Reliable data by a prospective study on the immunogenicity and safety of the inactivated poliovirus vaccines in Korean infants are required. Normal healthy infants aged 6–12 weeks received three doses of the vaccine (IPVAX™, Imovax Polio™ or Poliorix™) in intervals of 2 months. Neutralizing antibody (NTAb) titers were measured before and 4–6 weeks after three-dose primary vaccination. Immunogenicity was evaluated by seroconversion rates and geometric mean titers obtained by analyzing NTAb titers. Local and systemic adverse events were recorded during 7 days after each vaccination. A total of 150 infants were included: 40 in IPVAX™, 52 in Imovax Polio™, and 58 in Poliorix™. The seroconversion rates for the group vaccinated with IPVAX™ were 100% in types 1, 2 and 3, while those of Imovax Polio™ were 98.1%, 96.2%, 96.2% and those of Poliorix™ were 98.3%, 100%, 100%, respectively. In all groups, injection site redness and irritability were the most common local and systemic adverse events. Neither serious adverse events nor adverse events above grade 2 were reported throughout the study. The currently used inactivated poliovirus vaccines was demonstrated to be safe and immunogenic in healthy Korean infants.
机译:增强型灭活脊髓灰质炎疫苗于2002年首次引入,韩国已批准了几种灭活脊髓灰质炎疫苗。需要通过前瞻性研究获得的有关韩国婴儿灭活脊髓灰质炎病毒疫苗的免疫原性和安全性的可靠数据。年龄在6至12周的正常健康婴儿在2个月的间隔内接受了三剂疫苗(IPVAX™,Imovax Polio™或Poliorix™)。在三剂初次接种疫苗之前和之后的4–6周测量中和抗体(NTAb)的效价。通过血清转化率和通过分析NTAb滴度获得的几何平均滴度评估免疫原性。每次疫苗接种后7天内记录局部和全身不良事件。总共包括150名婴儿:IPVAX™中40名,Imovax Polio™中52名和Poliorix™中58名。在1、2和3型中,接种IPVAX™的组的血清转化率为100%,而Imovax Polio™的血清转化率为98.1%,96.2%,96.2%,而Poliorix™的血清转化率为98.3%,100%,100% , 分别。在所有组中,注射部位发红和易怒是最常见的局部和全身不良事件。在整个研究中,均未报告严重不良事件或2级以上不良事件。在健康的韩国婴儿中,目前使用的灭活的脊髓灰质炎病毒疫苗被证明是安全且具有免疫原性的。

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