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

NCT01987011 | Completed Phase 3

• 1 other identifier: MG1109_P3
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 4

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.

Conditions

Influenza

Keywords

Avian influenza

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• 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

Study Arms (2)

MG1109

EXPERIMENTAL

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

Biological: MG1109

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

MG1109 BIOLOGICAL

MG1109

Placebo BIOLOGICAL

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Green Cross Corporation: lead
• Korean Center for Disease Control and Prevention: collaborator

Study Sites (4)

Korea University Ansan Hospital

Ansan, South Korea

Location

Inha University Hospital

Inchon, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Catholic University Of Korea ST. Vincent's Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Bird Diseases; Animal Diseases

Study Officials

• Woo Joo Kim, MD, Ph.D

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: November 19, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 3, 2015

Record last verified: 2015-07

Locations

KR (4)