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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01987011

Enrollment

420

Registered

2013-11-19

Start date

2013-08-31

Completion date

2014-03-31

Last updated

2015-07-03

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

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.

Detailed description

MG1109 is purified, inactivated influenza viral antigen.

Interventions

BIOLOGICALMG1109

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 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
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
GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination	1st vaccination ~ 21 days after 2nd vaccination
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
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

Secondary

Measure	Time frame
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

Countries

South Korea

Outcome results

None listed

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