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

NCT01389466 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2014-11-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Korean Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Woo Joo Kim, MD, Ph.D · Korea University Guro Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
58 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389466 on ClinicalTrials.gov