NCT01389466

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 346 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 18 Years – 58 Years
• Healthy volunteers: Accepted

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.

Detailed description

MG1109 is purified, inactivated influenza viral antigen.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Step 1	Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days
BIOLOGICAL	Step 2	Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2011-07-08
• Last updated: 2014-11-21

Locations

4 sites across 1 country: South Korea