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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

Vaccines (Basel) 2022 Jun 2;10(6). Epub 2022 Jun 2.

Shandong Provincial Center for Disease Control and Prevention, Jinan 250014, 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 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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http://dx.doi.org/10.3390/vaccines10060895DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9230521PMC
June 2022

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