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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MG1109
Placebo
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Avian influenza

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Korea University Ansan Hospital
  • Inha University Hospital
  • Korea University Guro Hospital
  • Catholic University Of Korea ST. Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MG1109

Placebo

Arm Description

MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination
GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination
Vital signs(body temperature, pulse)
The results of physical examinations
Lab results(Hematology, Blood chemistry, Urinalysis)

Full Information

First Posted
July 22, 2013
Last Updated
July 1, 2015
Sponsor
Green Cross Corporation
Collaborators
Korean Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01987011
Brief Title
Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 in Healthy Adult Volunteers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
Collaborators
Korean Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Avian influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MG1109
Arm Type
Experimental
Arm Description
MG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days
Intervention Type
Biological
Intervention Name(s)
MG1109
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40
Time Frame
1st vaccination ~ 21 days after 2nd vaccination
Title
Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody
Time Frame
1st vaccination ~ 21 days after 2nd vaccination
Title
GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination
Time Frame
1st vaccination ~ 21 days after 2nd vaccination
Title
The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination
Time Frame
Each vaccination ~ 7 days after each vaccination
Title
The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination
Time Frame
1st vaccination ~ 24 weeks after 2nd vaccination
Secondary Outcome Measure Information:
Title
GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination
Time Frame
1st vaccination ~ 21 days after 2nd vaccination
Title
GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination
Time Frame
1st vaccination ~ 21 days after 2nd vaccination
Title
Vital signs(body temperature, pulse)
Time Frame
1st vaccination ~ 21 days after 2nd vaccination
Title
The results of physical examinations
Time Frame
1st vaccination ~ 21 days after 2nd vaccination
Title
Lab results(Hematology, Blood chemistry, Urinalysis)
Time Frame
1st vaccination ~ 21 days after 2nd vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woo Joo Kim, MD, Ph.D
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Inha University Hospital
City
Inchon
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Catholic University Of Korea ST. Vincent's Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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