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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01389466

Enrollment

346

Registered

2011-07-08

Start date

2010-02-28

Completion date

2011-12-31

Last updated

2014-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Avian influenza

Brief summary

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.

Detailed description

MG1109 is purified, inactivated influenza viral antigen.

Interventions

BIOLOGICALStep 1

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

BIOLOGICALStep 2

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 58 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group	42 days after vaccination
Number of subjects with Solicited / Unsolicited adverse events	With in 24 weeks after vaccination

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026