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NCT Number: NCT01389466

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

This study was designed in two steps with Step 1, a single-center, double-blind, randomized clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal study. The investigator 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–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Korea University Ansan Hospital, Ansan, South Korea

Loading trial locations.

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

Step 1

Biological

Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days

Step 2

Biological

Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days

Primary outcomes

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

    Time frame: 42 days after vaccination

  2. Number of subjects with Solicited / Unsolicited adverse events

    Time frame: With in 24 weeks after vaccination

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Collaborators

  • Korean Center for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 8, 2011
Registry last updated
Nov 21, 2014

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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