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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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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. |
format | Online Article Text |
id | pubmed-9230521 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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