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Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China

Background: The aim of this study was to investigate the immunogenicity and safety of the enterovirus 71 vaccine (EV71 vaccine) administered alone or simultaneously. Methods: A multi-center, open-label, randomized controlled trial was performed involving 1080 healthy infants aged 6 months or 8 month...

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Autores principales: Liu, Xiaodong, Chang, Shaoying, Wang, Ruize, Xiao, Yanhui, Li, Fangjun, Xu, Qing, Zhang, Shaobai, Chen, Xiao, Zhang, Shangxiao, Zhang, Min, Chen, Xiaoqi, Cao, Qingfan, Liu, Xiaoyu, Wang, Hui, Zhan, Daihong, Chen, Haiping, Chen, Wei, Jiang, Jianyong, Zhang, Chao, Wang, Haijiao, Gao, Lidong, Shi, Xuanwen, Yang, Xiaoming, Xu, Aiqiang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9230521/
https://www.ncbi.nlm.nih.gov/pubmed/35746502
http://dx.doi.org/10.3390/vaccines10060895
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author Liu, Xiaodong
Chang, Shaoying
Wang, Ruize
Xiao, Yanhui
Li, Fangjun
Xu, Qing
Zhang, Shaobai
Chen, Xiao
Zhang, Shangxiao
Zhang, Min
Chen, Xiaoqi
Cao, Qingfan
Liu, Xiaoyu
Wang, Hui
Zhan, Daihong
Chen, Haiping
Chen, Wei
Jiang, Jianyong
Zhang, Chao
Wang, Haijiao
Gao, Lidong
Shi, Xuanwen
Yang, Xiaoming
Xu, Aiqiang
author_facet Liu, Xiaodong
Chang, Shaoying
Wang, Ruize
Xiao, Yanhui
Li, Fangjun
Xu, Qing
Zhang, Shaobai
Chen, Xiao
Zhang, Shangxiao
Zhang, Min
Chen, Xiaoqi
Cao, Qingfan
Liu, Xiaoyu
Wang, Hui
Zhan, Daihong
Chen, Haiping
Chen, Wei
Jiang, Jianyong
Zhang, Chao
Wang, Haijiao
Gao, Lidong
Shi, Xuanwen
Yang, Xiaoming
Xu, Aiqiang
author_sort Liu, Xiaodong
collection PubMed
description Background: The aim of this study was to investigate the immunogenicity and safety of the enterovirus 71 vaccine (EV71 vaccine) administered alone or simultaneously. Methods: A multi-center, open-label, randomized controlled trial was performed involving 1080 healthy infants aged 6 months or 8 months from Shandong, Shanxi, Shaanxi, and Hunan provinces. These infants were divided into four simultaneous administration groups and EV71 vaccine separate administration group. Blood samples were collected from the infants before the first vaccination and after the completion of the vaccination. This trial was registered in the Clinical Trials Registry (NCT03519568). Results: A total of 895 were included in the per-protocol analysis. The seroconversion rates of antibodies against EV71 in four simultaneous administration groups (98.44% (189/192), 94.57% (122/129), 99.47% (187/188) and 98.45% (190/193)) were non-inferior to EV71 vaccine separate administration group (97.93% [189/193]) respectively. Fever was the most common adverse event, the pairwise comparison tests showed no difference in the incidence rate of solicited, systemic or local adverse events. Three serious adverse events related to the vaccination were reported. Conclusions: The evidence of immunogenicity and safety supports that the EV71 vaccine administered simultaneously with vaccines need to be administered during the same period of time recommended in China.
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spelling pubmed-92305212022-06-25 Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China Liu, Xiaodong Chang, Shaoying Wang, Ruize Xiao, Yanhui Li, Fangjun Xu, Qing Zhang, Shaobai Chen, Xiao Zhang, Shangxiao Zhang, Min Chen, Xiaoqi Cao, Qingfan Liu, Xiaoyu Wang, Hui Zhan, Daihong Chen, Haiping Chen, Wei Jiang, Jianyong Zhang, Chao Wang, Haijiao Gao, Lidong Shi, Xuanwen Yang, Xiaoming Xu, Aiqiang Vaccines (Basel) Article Background: The aim of this study was to investigate the immunogenicity and safety of the enterovirus 71 vaccine (EV71 vaccine) administered alone or simultaneously. Methods: A multi-center, open-label, randomized controlled trial was performed involving 1080 healthy infants aged 6 months or 8 months from Shandong, Shanxi, Shaanxi, and Hunan provinces. These infants were divided into four simultaneous administration groups and EV71 vaccine separate administration group. Blood samples were collected from the infants before the first vaccination and after the completion of the vaccination. This trial was registered in the Clinical Trials Registry (NCT03519568). Results: A total of 895 were included in the per-protocol analysis. The seroconversion rates of antibodies against EV71 in four simultaneous administration groups (98.44% (189/192), 94.57% (122/129), 99.47% (187/188) and 98.45% (190/193)) were non-inferior to EV71 vaccine separate administration group (97.93% [189/193]) respectively. Fever was the most common adverse event, the pairwise comparison tests showed no difference in the incidence rate of solicited, systemic or local adverse events. Three serious adverse events related to the vaccination were reported. Conclusions: The evidence of immunogenicity and safety supports that the EV71 vaccine administered simultaneously with vaccines need to be administered during the same period of time recommended in China. MDPI 2022-06-02 /pmc/articles/PMC9230521/ /pubmed/35746502 http://dx.doi.org/10.3390/vaccines10060895 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Liu, Xiaodong
Chang, Shaoying
Wang, Ruize
Xiao, Yanhui
Li, Fangjun
Xu, Qing
Zhang, Shaobai
Chen, Xiao
Zhang, Shangxiao
Zhang, Min
Chen, Xiaoqi
Cao, Qingfan
Liu, Xiaoyu
Wang, Hui
Zhan, Daihong
Chen, Haiping
Chen, Wei
Jiang, Jianyong
Zhang, Chao
Wang, Haijiao
Gao, Lidong
Shi, Xuanwen
Yang, Xiaoming
Xu, Aiqiang
Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China
title Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China
title_full Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China
title_fullStr Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China
title_full_unstemmed Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China
title_short Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China
title_sort immunogenicity and safety of an inactivated enterovirus 71 vaccine administered simultaneously with hepatitis b virus vaccine, group a meningococcal polysaccharide vaccine, measles-rubella combined vaccine and japanese encephalitis vaccine: a multi-center, randomized, controlled clinical trial in china
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9230521/
https://www.ncbi.nlm.nih.gov/pubmed/35746502
http://dx.doi.org/10.3390/vaccines10060895
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