Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial

Zhang Zewu; Liang Zhenglun; Zeng Ji; Zhang Jikai; He Peng; Su Jiali; Zeng Yaoming; Fan Renfeng; Zhao Dan; Ma Wenjun; Zeng Gang; Zhang Qiaoli; Zheng Huizhen

首页> 外文期刊>The Journal of Infectious Diseases >Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial

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Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial

机译：与乙型肝炎疫苗同时施用的灭活肠道病毒71疫苗的免疫原性和安全性和脑膜炎球菌多糖疫苗：曝光疫苗疫苗：阶段4，开放标签，单中心，随机，非闭合性试验

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Background This study tested the hypothesis that the immunogenicity and safety of the simultaneous administration of enterovirus 71 (EV71) vaccine (dose 1) with recombinant hepatitis B vaccine (HepB) on day 1 and EV71 vaccine (dose 2) with group A meningococcal polysaccharide vaccine (MenA) on day 30 is not inferior to separate administration of each vaccine.

机译：背景技术本研究测试了在第1天和第1天和EV71疫苗（剂量2）时同时施用肠道病毒71（EV71）疫苗（DOSE 1）与重组乙型肝炎疫苗（HEPB）的免疫原性和安全性的假设。用脑膜炎球菌多糖疫苗（MENA）在第30天不差不等于单独的每种疫苗的给药。

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来源
《The Journal of Infectious Diseases》 |2019年第3期|共8页
作者
Zhang Zewu; Liang Zhenglun; Zeng Ji; Zhang Jikai; He Peng; Su Jiali; Zeng Yaoming; Fan Renfeng; Zhao Dan; Ma Wenjun; Zeng Gang; Zhang Qiaoli; Zheng Huizhen;
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作者单位

Ctr Dis Control &

Prevent Dongguan City Dongguan Peoples R China;

Natl Inst Food &

Drug Control Beijing Peoples R China;

Sinovac Biotech 39 Shangdi Western Rd Beijing Peoples R China;

Guangdong Prov Inst Biol Prod &

Mat Med Guangzhou Guangdong Peoples R China;

Natl Inst Food &

Drug Control Beijing Peoples R China;

Guangdong Prov Inst Biol Prod &

Mat Med Guangzhou Guangdong Peoples R China;

Ctr Dis Control &

Prevent Dongguan City Dongguan Peoples R China;

Guangdong Prov Inst Biol Prod &

Mat Med Guangzhou Guangdong Peoples R China;

Natl Inst Food &

Drug Control Beijing Peoples R China;

Guangdong Prov Inst Publ Hlth Guangzhou Guangdong Peoples R China;

Sinovac Biotech 39 Shangdi Western Rd Beijing Peoples R China;

Ctr Dis Control &

Prevent Dongguan City Dongguan Peoples R China;

Guangdong Prov Ctr Dis Control &

Prevent Guangzhou Guangdong Peoples R China;

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原文格式 PDF
正文语种 eng
中图分类传染病;
关键词
Simultaneous administration; EV71 vaccine; immunogenicity;

机译：同时给药;EV71疫苗;免疫原性;

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1. Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial [J] . Zhang Zewu, Liang Zhenglun, Zeng Ji, The Journal of Infectious Diseases . 2019,第3期

机译：与乙型肝炎疫苗同时施用的灭活肠道病毒71疫苗的免疫原性和安全性和脑膜炎球菌多糖疫苗：曝光疫苗疫苗：阶段4，开放标签，单中心，随机，非闭合性试验
2. Safety and immunogenicity of investigational seasonal influenza hemagglutinin DNA vaccine followed by trivalent inactivated vaccine administered intradermally or intramuscularly in healthy adults: An open-label randomized phase 1 clinical trial [J] . Cristina Carter, Katherine V. Houser, Galina V. Yamshchikov, PLoS One . 2019,第9期

机译：调查季节性流感血凝素DNA疫苗的安全性和免疫原性，然后是在健康成人的皮内或肌肉内施用的三价灭活疫苗：开放式随机阶段1临床试验
3. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine co-administered with a 23-valent pneumococcal polysaccharide vaccine versus separate administration, in adults 鈮?0years of age: Results from a phase III, randomized, non-inferiority trial [J] . Opokua Ofori-Anyinam, Geert Leroux-Roels, Mamadou Drame, Vaccine . 2017,第46期

机译：将灭活的四价流感疫苗的免疫原性和安全性与23价肺炎球菌多糖疫苗与单独给药，在成人中，在成人中，年龄为0年：III期，随机，非劣级审判的结果
4. A double-blind, randomized phase II trial of thesafety and immunogenicity of 26-valent group A streptococcus vaccine in healthy adults [C] . Shelly A. McNeil, Scott A. Halperin, Joanne M. Langley, Lancefield International Symposium on Streptococci and Streptococcal Diseases . 2006

机译：一种双盲，随机期II试验，对健康成人的26岁的26岁群体的疫苗疫苗
5. Immunogenicity of quadrivalent meningococcal polysaccharide vaccine in children during a mass immunization campaign [D] . King, W. James 1995

机译：儿童大规模免疫接种过程中四价脑膜炎球菌多糖疫苗的免疫原性
6. Safety and immunogenicity of investigational seasonal influenza hemagglutinin DNA vaccine followed by trivalent inactivated vaccine administered intradermally or intramuscularly in healthy adults: An open-label randomized phase 1 clinical trial [O] . Cristina Carter, Katherine V. Houser, Galina V. Yamshchikov, 2012

机译：研究性季节性流感血凝素DNA疫苗以及三价灭活疫苗在健康成年人体内皮内或肌肉内给药的安全性和免疫原性：一项开放标签的随机1期临床试验

Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial

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