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Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects

Hand, Foot and Mouth Disease Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of High-dose IN-B001 After Administration in Healthy Subjects

Clinical Trial Summary

This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 after administration in healthy subjects

Clinical Trial Description

Enterovirus 71(EV71) and coxsackievirus A16(CVA16) are major causes of Hand-foot-and-mouth disease (HFMD) occurring in pediatric population. Although EV71 vaccine has been licensed in China, vaccine for CVA16-associated HFMD is currently not available anywhere. The purpose of this phase I study is to evaluate the safety and immunogenicity of EV71/CVA16 bivalent vaccine in healthy adults. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04637919
Study type Interventional
Source HK inno.N Corporation
Contact Naree Shin, MS
Phone +82-2-6477-0271
Email naree.shin@inno-n.com
Status Not yet recruiting
Phase Phase 1
Start date December 2020
Completion date December 2021
View Details
See also
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