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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

Authors :
Xiaodong Liu
Shaoying Chang
Ruize Wang
Yanhui Xiao
Fangjun Li
Qing Xu
Shaobai Zhang
Xiao Chen
Shangxiao Zhang
Min Zhang
Xiaoqi Chen
Qingfan Cao
Xiaoyu Liu
Hui Wang
Daihong Zhan
Haiping Chen
Wei Chen
Jianyong Jiang
Chao Zhang
Haijiao Wang
Lidong Gao
Xuanwen Shi
Xiaoming Yang
Aiqiang Xu
Source :
Vaccines, Vol 10, Iss 6, p 895 (2022)
Publication Year :
2022
Publisher :
MDPI AG, 2022.

Abstract

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.

Details

Language :
English
ISSN :
2076393X
Volume :
10
Issue :
6
Database :
Directory of Open Access Journals
Journal :
Vaccines
Publication Type :
Academic Journal
Accession number :
edsdoj.0369d4bdc1924fb08997e66cdb77838c
Document Type :
article
Full Text :
https://doi.org/10.3390/vaccines10060895