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

Green Cross Corporation

Status and phase: Completed; Phase 2; Phase 1

Conditions: Influenza

Treatments: Biological: Step 1; Biological: Step 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01389466

MG1109_P1/2

Details and patient eligibility

About

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.

Full description

MG1109 is purified, inactivated influenza viral antigen.

Enrollment: 346 patients

Sex: All

Ages: 18 to 58 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: Single Blind

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346 participants in 3 patient groups, including a placebo group

MG1109 - Step 1

Experimental group

Treatment:

Biological: Step 1

Normal Saline - Step 1

Placebo Comparator group

Treatment:

Biological: Step 1

MG1109 - Step 2

Experimental group

Treatment:

Biological: Step 2