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Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj — BR-JELITE  

Japanese Encephalitis Clinical Trial

Official title:
A Multi-center, Open, phase4 Study to Assess the Long-term Immunogenicity and Safety of Fourth Administration of BR JEV and to Investigate on Vaccine Interchangeability in Children Aged 6 Years Who Received 3 Doses With ENCEVAC or JEV-GCC

Clinical Trial Summary

A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj. and to conduct an exploratory investigation on vaccine interchangeability in Korean children aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC® inj.

Clinical Trial Description

This is a follow-up study of KD287-BR-CT-301 (ClinicalTrials.gov identifier: NCT01150942), a phase 3 study to investigate the efficacy and safety of a cell-culture Japanese encephalitis vaccine (ENCEVAC®) compared with that of a mouse brain-derived Japanese encephalitis vaccine (Japanese Encephalitis vaccine-GCC® inj). Subjects participated in KD287-BR-CT-301 study were to receive 3 doses of Japanese encephalitis vaccine (JEV) assigned by randomization from the age of 12 months and those subjects who completed the 3 doses of JEV are the target population in this study. The purpose of this study is to investigate the long-term immunogenicity and safety of the booster (fourth) dose of JEV, which will be given as Boryung Cell-Culture Japanese Encephalitis Vaccine inj, proven to be same with ENCEVAC® but manufactured by a different manufacturer. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02532569
Study type Interventional
Source Boryung Pharmaceutical Co., Ltd
Contact
Status Completed
Phase Phase 4
Start date August 2015
Completion date October 2016
View Details
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