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
1 other identifier
interventional
346
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2010
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 19, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedNovember 21, 2014
November 1, 2014
1.7 years
June 19, 2011
November 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
MG1109 - Step 1
EXPERIMENTALNormal Saline - Step 1
PLACEBO COMPARATORMG1109 - Step 2
EXPERIMENTALInterventions
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
Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days
Eligibility Criteria
You may qualify if:
- Healthy adults who are available for follow-up during the study
You may not qualify if:
- Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
- Subjects with immune system disorder including immune deficiency disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Korea University Ansan Hospital
Ansan, South Korea
Inha University Hospital
Inchon, South Korea
Korea University Guro Hospital
Seoul, South Korea
Catholic University Of Korea ST. Vincent's Hospital
Suwon, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Woo Joo Kim, MD, Ph.D
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2011
First Posted
July 8, 2011
Study Start
February 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
November 21, 2014
Record last verified: 2014-11