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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01987011
First received: July 22, 2013
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: MG1109
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 [ Time Frame: 1st vaccination ~ 21 days after 2nd vaccination ] [ Designated as safety issue: No ]
  • Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody [ Time Frame: 1st vaccination ~ 21 days after 2nd vaccination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination [ Time Frame: 1st vaccination ~ 21 days after 2nd vaccination ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Vital signs(body temperature, pulse) [ Time Frame: 1st vaccination ~ 21 days after 2nd vaccination ] [ Designated as safety issue: Yes ]
  • The results of physical examinations [ Time Frame: 1st vaccination ~ 21 days after 2nd vaccination ] [ Designated as safety issue: No ]
  • Lab results(Hematology, Blood chemistry, Urinalysis) [ Time Frame: 1st vaccination ~ 21 days after 2nd vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: August 2013
Study Completion Date: March 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MG1109 Biological: MG1109
Investigational Product : MG1109 Dose : 0.5 mL Intramuscularly injection, twice at an interval of 21 days
Placebo Comparator: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987011

Locations
Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of
Inha University Hospital
Inchon, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Catholic University Of Korea ST. Vincent's Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Investigators
Principal Investigator: Woo Joo Kim, MD, Ph.D Korea University Guro Hospital
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01987011     History of Changes
Other Study ID Numbers: MG1109_P3
Study First Received: July 22, 2013
Last Updated: April 9, 2014
Health Authority: South Korea: Ministry of Food and Drug Safety(MFDS)

Keywords provided by Green Cross Corporation:
Avian influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014