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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.不同制造商生产的三种强化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:一项前瞻性多中心研究。
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2
Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study.健康韩国婴儿中三联 DTPa-IPV/Hib 疫苗作为三剂基础免疫接种程序的免疫原性和安全性:III 期、随机研究。
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Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.
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Immunogenicity and safety of a new liquid hexavalent combined vaccine compared with separate administration of reference licensed vaccines in infants.一种新型液体六价联合疫苗与婴儿使用的已获许可的对照疫苗单独接种相比的免疫原性和安全性。
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本文引用的文献

1
Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China.在中国,婴幼儿接种灭活脊髓灰质炎疫苗(IPV)进行基础免疫和加强免疫具有免疫原性且耐受性良好。
Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.
2
Inactivated poliovirus vaccine given alone or in a sequential schedule with bivalent oral poliovirus vaccine in Chilean infants: a randomised, controlled, open-label, phase 4, non-inferiority study.在智利婴儿中单独使用或与二价口服脊髓灰质炎疫苗序贯使用灭活脊髓灰质炎病毒疫苗:一项随机、对照、开放性标签、四期、非劣效性研究。
Lancet Infect Dis. 2015 Nov;15(11):1273-82. doi: 10.1016/S1473-3099(15)00219-4. Epub 2015 Aug 26.
3
Immunogenicity and persistence from different 3-dose schedules of live and inactivated polio vaccines in Chinese infants.中国婴儿中不同三剂次活疫苗和灭活脊髓灰质炎疫苗接种程序的免疫原性及持久性
Vaccine. 2015 Aug 26;33(36):4653-8. doi: 10.1016/j.vaccine.2014.08.091. Epub 2015 Feb 11.
4
Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea.在韩国,一项比较联合使用无细胞百白破、灭活脊髓灰质炎(DTaP-IPV)疫苗与分别单独使用百白破(DTaP)和脊髓灰质炎(IPV)疫苗的免疫原性和安全性的随机对照研究:在婴儿中进行的研究。
Vaccine. 2011 Feb 11;29(8):1551-7. doi: 10.1016/j.vaccine.2010.12.094. Epub 2011 Jan 6.
5
Immunogenicity and safety of a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type B conjugate combination vaccine (Pentaxim) with hepatitis B vaccine.五联疫苗(DTaP-IPV/Hib 联合疫苗)与乙型肝炎疫苗联合免疫的免疫原性和安全性。
Indian Pediatr. 2009 Nov;46(11):975-82.
6
Randomized trial of inactivated and live polio vaccine schedules in Guatemalan infants.危地马拉婴儿灭活脊髓灰质炎疫苗和减毒活脊髓灰质炎疫苗接种程序的随机试验。
J Infect Dis. 2007 Sep 1;196(5):692-8. doi: 10.1086/520546. Epub 2007 Jul 23.
7
Serologic response to inactivated poliovirus vaccine: a randomized clinical trial comparing 2 vaccination schedules in Puerto Rico.对灭活脊髓灰质炎病毒疫苗的血清学反应:在波多黎各比较两种疫苗接种方案的一项随机临床试验
J Infect Dis. 2007 Jan 1;195(1):12-20. doi: 10.1086/508427. Epub 2006 Nov 28.
8
Safety and immunogenicity of a diphtheria, tetanus, and acellular pertussis-inactivated poliovirus vaccine/Haemophilus influenzae type B combination vaccine administered to Taiwanese infants at 2, 4, and 6 months of age.
Chang Gung Med J. 2003 May;26(5):315-22.
9
Certification of poliomyelitis eradication--Western Pacific Region, October 2000.西太平洋区域2000年10月根除脊髓灰质炎认证
MMWR Morb Mortal Wkly Rep. 2001 Jan 12;50(1):1-3.
10
Immunogenicity study of a combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis vaccine used to reconstitute a freeze-dried Haemophilus influenzae type b vaccine (DTaP-IPV//PRP-T) administered simultaneously with a hepatitis B vaccine at two, three and four months of life.在2、3、4月龄时同时接种乙型肝炎疫苗的情况下,用于复溶冻干b型流感嗜血杆菌疫苗(DTaP-IPV//PRP-T)的白喉、破伤风、无细胞百日咳、灭活脊髓灰质炎联合疫苗的免疫原性研究。
Vaccine. 1999 Dec 10;18(9-10):947-54. doi: 10.1016/s0264-410x(99)00331-x.

不同制造商生产的三种强化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:一项前瞻性多中心研究。

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

作者信息

Kwak Byung Ok, Ma Sang Hyuk, Park Su Eun, Shin Seon Hee, Choi Kyung Min, Lee Taek-Jin, Eun Byung Wook, Hong Young Jin, Kim Dong Hyun

机构信息

Department of Pediatrics, Hallym University Kangnam Sacred Heart Hospital, Seoul 07441, Korea.

Department of Pediatrics, Changwon Fatima Hospital, Changwon 51394, Korea.

出版信息

Vaccines (Basel). 2020 Apr 26;8(2):200. doi: 10.3390/vaccines8020200.

DOI:10.3390/vaccines8020200
PMID:32357552
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7349543/
Abstract

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.

摘要

强化灭活脊髓灰质炎疫苗于2002年首次引入,韩国有几种灭活脊髓灰质炎疫苗获得许可。需要通过前瞻性研究获得关于韩国婴儿中灭活脊髓灰质炎疫苗免疫原性和安全性的可靠数据。6至12周龄的正常健康婴儿每隔2个月接种三剂疫苗(IPVAX™、Imovax Polio™或Poliorix™)。在三剂基础疫苗接种前和接种后4至6周测量中和抗体(NTAb)滴度。通过分析NTAb滴度获得的血清转化率和几何平均滴度评估免疫原性。每次接种后7天记录局部和全身不良事件。共纳入150名婴儿:40名接种IPVAX™,52名接种Imovax Polio™,58名接种Poliorix™。接种IPVAX™组1型、2型和3型的血清转化率均为100%,而接种Imovax Polio™组的血清转化率分别为98.1%、96.2%、96.2%,接种Poliorix™组的血清转化率分别为98.3%、100%、100%。在所有组中,注射部位发红和易激惹是最常见的局部和全身不良事件。在整个研究过程中,未报告严重不良事件或2级以上不良事件。目前使用的灭活脊髓灰质炎疫苗在健康的韩国婴儿中被证明是安全且具有免疫原性的。