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

Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Immunogenicity and Safety of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Placebo; Biological: MG1109

Detailed Description

MG1109 is purified, inactivated influenza viral antigen.

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
    • Korea University Ansan Hospital
  • Inchon, Korea, Republic of
    • Inha University Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Suwon, Korea, Republic of
    • Catholic University of Korea St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MG1109; MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days	Biological: MG1109
Placebo Comparator: Placebo; Placebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days	Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40	1st vaccination ~ 21 days after 2nd vaccination
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 solicited adverse events from the date of vaccination until 7 days after each vaccination	Each vaccination ~ 7 days after each 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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Vital signs(body temperature, pulse)	1st vaccination ~ 21 days after 2nd vaccination
The results of physical examinations	1st vaccination ~ 21 days after 2nd vaccination
Lab results(Hematology, Blood chemistry, Urinalysis)	1st vaccination ~ 21 days after 2nd vaccination

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Collaborators: Korean Center for Disease Control and Prevention
• Investigators: Principal Investigator: Woo Joo Kim, MD, Ph.D, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimate): November 19, 2013

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: July 1, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Avian influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: MG1109_P3