Evaluation of the Safety and Immunogenicity of Simultaneously Administration of EV71 Vaccine and Influenza Vaccine

Summary

Subjects will be recruited and divided into 3 groups: 1. Experimental Group (378 subjects): combined immunization of EV71 vaccine and influenza vaccine; 2. Control Group A (378 subjects): EV71 vaccine only; 3. Control Group B (378 subjects): influenza vaccine only; All blood samples will be collected before and one month after vaccinatioin. The immunogenicity and safety of both experimental and control groups will be compared and the data be analyzed.

Timeline

Start

2019-09-26

Primary completion

2020-01-06

Completion

2021-08-10

Publications

• Chen Y, Xiao Y, Ye Y, Jiang F, He H, Luo L, Chen H, Shi L, Mu Q, Chen W, Guo X, Zhang M, Li J, Guan Q, Chen Z, Yang X. Immunogenicity and safety of an inactivated enterovirus 71 vaccine coadministered with trivalent split-virion inactivated influenza vaccine: A phase 4, multicenter, randomized, controlled trial in China. Front Immunol. 2022 Dec 8;13:1080408. doi: 10.3389/fimmu.2022.1080408. eCollection 2022.

Drugs

Indications