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

Green Cross Corporation

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: MG1109; Biological: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01987011

MG1109_P3

Details and patient eligibility

About

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.

Full description

MG1109 is purified, inactivated influenza viral antigen.

Enrollment: 420 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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420 participants in 2 patient groups, including a placebo group

MG1109

Experimental group

Description:

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

Treatment:

Biological: MG1109

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: Placebo