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

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: Step 2; Biological: Step 1

• Registration Number: NCT01389466
• Lead Sponsor: Green Cross Corporation

Brief 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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2011-06-19
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• Healthy adults who are available for follow-up during the study

Exclusion Criteria

• Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
• Subjects with immune system disorder including immune deficiency disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MG1109 - Step 2	Step 2	-
MG1109 - Step 1	Step 1	-
Normal Saline - Step 1	Step 1	-

Primary Outcome Measures

Name	Time	Method
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group	42 days after vaccination
Number of subjects with Solicited / Unsolicited adverse events	With in 24 weeks after vaccination

Trial Locations

Locations (4)

Inha University Hospital; 🇰🇷 Inchon, Korea, Republic of

Korea University Ansan Hospital; 🇰🇷 Ansan, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Catholic University Of Korea ST. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of