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drugset / Trial / NCT01389466

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

NCT01389466 ↗

Phase 1/2 Completed 346 enrolled Green Cross Corporation Korean Center for Disease Control and Prevention · collab
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2010-02
Primary completion
2011-11
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject MG1109 Vaccine 0.125 ml Intramuscular
Subject MG1109 Vaccine 0.25 ml Intramuscular
Subject MG1109 Vaccine 0.5 ml Intramuscular
Subject MG1109 Vaccine 1 ml Intramuscular

Indications

influenza