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

被引:5
|
作者
Liu, Xiaodong [1 ,2 ]
Chang, Shaoying [3 ]
Wang, Ruize [4 ]
Xiao, Yanhui [5 ]
Li, Fangjun [6 ]
Xu, Qing [1 ,2 ]
Zhang, Shaobai [4 ]
Chen, Xiao [3 ]
Zhang, Shangxiao [6 ]
Zhang, Min [5 ]
Chen, Xiaoqi [7 ]
Cao, Qingfan [8 ]
Liu, Xiaoyu [4 ]
Wang, Hui [3 ]
Zhan, Daihong [9 ]
Chen, Haiping [5 ]
Chen, Wei [7 ]
Jiang, Jianyong [10 ]
Zhang, Chao [4 ]
Wang, Haijiao [3 ]
Gao, Lidong [6 ]
Shi, Xuanwen [5 ]
Yang, Xiaoming [5 ]
Xu, Aiqiang [1 ,2 ]
机构
[1] Shandong Prov Ctr Dis Control & Prevent, Jinan 250014, Peoples R China
[2] Shandong Univ, Acad Prevent Med, Jinan 250100, Peoples R China
[3] Shanxi Prov Ctr Dis Control & Prevent, Taiyuan 030012, Peoples R China
[4] Shaanxi Prov Ctr Dis Control & Prevent, Xian 710054, Peoples R China
[5] China Natl Biotec Grp Co Ltd, Beijing 100024, Peoples R China
[6] Hunan Prov Ctr Dis Control & Prevent, Changsha 410005, Peoples R China
[7] Wuhan Inst Biol Prod Co Ltd, Wuhan 430200, Peoples R China
[8] Rushan City Ctr Dis Control & Prevent, Rushan 264500, Peoples R China
[9] Shimen Cty Ctr Dis Control & Prevent, Changde 415300, Peoples R China
[10] Haiyang City Ctr Dis Control & Prevent, Haiyang 265199, Peoples R China
关键词
inactivated enterovirus 71 vaccine; simultaneous administration; hand; foot and mouth disease; separate administration; MOUTH-DISEASE; DOUBLE-BLIND; CHILDREN; EFFICACY; FOOT; HAND; OUTBREAK;
D O I
10.3390/vaccines10060895
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
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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页数:11
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