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Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers

Influenza Clinical Trial

Official title:
Randomized Phase I/II Study to Evaluate the Safety and Immunogenicity of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers

Clinical Trial Summary

This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator evaluate the immunogenicity and safety of the investigational vaccine in the subjects during their participation in the study.

Clinical Trial Description

MG1109 is purified, inactivated influenza viral antigen. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01389466
Study type Interventional
Source Green Cross Corporation
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 2010
Completion date December 2011
View Details
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