InfluenzaPhase 1/2NCT01389466
Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers
A Phase 1/2 study testing Step 1 and Step 2 in people with Influenza, run by Green Cross Corporation at 4 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Step 1 and Step 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Feb 2010to Dec 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults who are available for follow-up during the study
Who cannot join
- Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
- Subjects with immune system disorder including immune deficiency disease
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Korea University Ansan Hospital
Ansan
Inha University Hospital
Inchon
Korea University Guro Hospital
Seoul
Catholic University Of Korea ST. Vincent's Hospital
Suwon
About this study
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
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.
Read the detailed description
MG1109 is purified, inactivated influenza viral antigen.
- Conditions
- Influenza
- Being tested
- Step 1, Step 2
- Keywords
- Avian influenza
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step 1Biological
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 2Biological
Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days
| Study group | Role | What they receive |
|---|---|---|
| MG1109 - Step 1 | Experimental | Not described Receives: Biological: Step 1 |
| Normal Saline - Step 1 | Placebo comparator | Not described Receives: Biological: Step 1 |
| MG1109 - Step 2 | Experimental | Not described Receives: Biological: Step 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group
Measured: 42 days after vaccination
Number of subjects with Solicited / Unsolicited adverse events
Measured: With in 24 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startFeb 2010
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korean Center for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Woo Joo Kim, MD, Ph.D, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389466
- Sponsor's protocol ID
- MG1109_P1/2
- Status last verified
- Nov 2014
- First submitted
- 19 Jun 2011
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01389466
- Acronym / sponsor ID
- MG1109_P1/2
- Conditions
- Influenza
- Keywords
- Avian influenza
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Korean Center for Disease Control and Prevention
- Study start
- Feb 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MG1109 is purified, inactivated influenza viral antigen.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MG1109 - Step 1 | Experimental | Biological: Step 1 |
| Normal Saline - Step 1 | Placebo comparator | Biological: Step 1 |
| MG1109 - Step 2 | Experimental | Biological: Step 2 |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adults who are available for follow-up during the study
Key exclusion criteria (2 listed)
- Subjects with history of exposure to the H5N1 subtype or H5N1 subtype vaccine
- Subjects with immune system disorder including immune deficiency disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step 1Investigational 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 | Biological | MG1109 - Step 1, Normal Saline - Step 1 |
| Step 2Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days | Biological | MG1109 - Step 2 |
Primary outcome
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group
Time frame: 42 days after vaccination
Number of subjects with Solicited / Unsolicited adverse events
Time frame: With in 24 weeks after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Joo Kim, MD, Ph.D principal investigator
Korea University Guro Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Step 1 and Step 2 in people with Influenza, run by Green Cross Corporation at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40 in each dose group (time frame: 42 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.