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Completed

NCT Number: NCT01987011

Phase III Study to Evaluate the Immunogenicity and Safety of MG1109 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.

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Key information

Conditions

Influenza Animal Diseases Bird Diseases Infections Influenza in Birds Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

MG1109 is purified, inactivated influenza viral antigen.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MG1109

Biological

Placebo

Biological

Primary outcomes

  1. Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40

    Time frame: 1st vaccination ~ 21 days after 2nd vaccination

  2. Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody

    Time frame: 1st vaccination ~ 21 days after 2nd vaccination

  3. 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

  4. 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

  5. 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 outcomes

  1. GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination

    Time frame: 1st vaccination ~ 21 days after 2nd vaccination

  2. 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

  3. Vital signs(body temperature, pulse)

    Time frame: 1st vaccination ~ 21 days after 2nd vaccination

  4. The results of physical examinations

    Time frame: 1st vaccination ~ 21 days after 2nd vaccination

  5. Lab results(Hematology, Blood chemistry, Urinalysis)

    Time frame: 1st vaccination ~ 21 days after 2nd vaccination

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Collaborators

  • Korean Center for Disease Control and Prevention

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 19, 2013
Registry last updated
Jul 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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