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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: MG1109; Biological: Placebo

• Registration Number: NCT01987011
• Lead Sponsor: Green Cross Corporation

Brief Summary

The purpose of this study is to 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 First Submitted: 2013-07-22
• Study Start: 2013-08
• Primary Completion: 2013-10
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Study Completion: 2014-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-01
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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	MG1109	MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days
Placebo	Placebo	Placebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days

Primary Outcome Measures

Name	Time	Method
Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody	1st vaccination ~ 21 days after 2nd vaccination
GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination	1st vaccination ~ 21 days after 2nd vaccination
The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination	1st vaccination ~ 24 weeks after 2nd vaccination
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40	1st vaccination ~ 21 days after 2nd vaccination
The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination	Each vaccination ~ 7 days after each vaccination

Secondary Outcome Measures

Name	Time	Method
Lab results(Hematology, Blood chemistry, Urinalysis)	1st vaccination ~ 21 days after 2nd vaccination
Vital signs(body temperature, pulse)	1st vaccination ~ 21 days after 2nd vaccination
The results of physical examinations	1st vaccination ~ 21 days after 2nd vaccination
GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination	1st vaccination ~ 21 days after 2nd vaccination
GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination	1st vaccination ~ 21 days after 2nd 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