Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine With EPI Vaccines

Phase 4 Completed 780 enrolled Sinovac Biotech Co., Ltd Guangdong Center for Disease Prevention and Control · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of this study is to evaluate the safety and immunogenicity of concomitant administration of EV71 vaccine with recombinant hepatitis B vaccine/Group A meningococcal polysaccharide vaccine.

Timeline

Start: 2017-04-22
Primary completion: 2017-11-01
Completion: 2017-11-01

Outcome

Met primary endpoint

paper were not inferior to those in SE1 or SE2 group PMID 30891604 ↗

paper Simultaneous administration of combined EV71 vaccine with HepB and MenA has noninferior immunogenicity and safety, compared with separate administration of these vaccines. PMID 30891604 ↗

Publications

Zhang Z, Liang Z, Zeng J, Zhang J, He P, Su J, Zeng Y, Fan R, Zhao D, Ma W, Zeng G, Zhang Q, Zheng H. Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously With Hepatitis B Vaccine and Group A Meningococcal Polysaccharide Vaccine: A Phase 4, Open-Label, Single-Center, Randomized, Noninferiority Trial. J Infect Dis. 2019 Jul 2;220(3):392-399. doi: 10.1093/infdis/jiz129.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EV71 vaccine	Vaccine	0.5 ml	Intramuscular
Subject	Group A meningococcal polysaccharide vaccine	Vaccine	150 ug	Subcutaneous
Subject	recombinant hepatitis B vaccine	Vaccine	0.5 ml	Intramuscular