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NCT01389466 Clinical Trial

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

Influenza Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01389466
Other study ID # MG1109_P1/2
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 19, 2011
Last updated November 20, 2014
Start date February 2010
Est. completion date December 2011

Study information
Verified date November 2014
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Interventional

Clinical Trial 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.

Description:

MG1109 is purified, inactivated influenza viral antigen.

Recruitment information / eligibility
Status Completed
Enrollment 346
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 58 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Korea University Ansan Hospital Ansan
Korea, Republic of Inha University Hospital Inchon
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Catholic University Of Korea ST. Vincent's Hospital Suwon

Sponsors (2)
Lead Sponsor Collaborator
Green Cross Corporation Korean Center for Disease Control and Prevention

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer = 1:40 in each dose group 42 days after vaccination No
Primary Number of subjects with Solicited / Unsolicited adverse events With in 24 weeks after vaccination Yes
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