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drugset / Trial / NCT01150942

Clinical Trial to Assess the Immunogenicity and Safety of the Vero Cell-derived JE Vaccine in Korea

NCT01150942 ↗

Phase 3 Completed 205 enrolled Boryung Pharmaceutical Co., Ltd Ewha Womans University · collab Gachon University Gil Medical Center · collab Inha University Hospital · collab Inje University · collab Korea Cancer Center Hospital · collab Kyunghee University Medical Center · collab Samsung Medical Center · collab Seoul National University Hospital · collab The Catholic University of Korea · collab Wonju Severance Christian Hospital · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

To assess the immunogenicity and safety of the vero cell-derived inactivated JE vaccine in Korean healthy children aged 12\~23 months

Timeline

Start: 2010-08
Primary completion: 2012-09
Completion: 2013-02

Publications

Yun KW, Lee HJ, Kang JH, Eun BW, Kim YJ, Kim KH, Kim NH, Hong YJ, Kim DH, Kim HM, Cha SH. Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC(R)) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial. BMC Infect Dis. 2015 Jan 8;15:7. doi: 10.1186/s12879-014-0744-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	JE vaccine	Vaccine	—	Intramuscular
Subject	JEV-GCC	Vaccine	—	Intramuscular

Indications