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InfluenzaPhase 3NCT01987011

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

A Phase 3 study testing MG1109 in people with Influenza, run by Green Cross Corporation at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
MG1109
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
4 sitesSouth Korea
Study dates
Aug 2013to Mar 2014
Phase
Phase 3
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 60 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

Other trials in South Korea

About this study

Official title: Randomized, Double Blind, Multicenter, Phase III Study to Evaluate the Immunogenicity and Safety of 'MG1109(Egg-based, Pre-pandemic Influenza(H5N1) Vaccine)' Administered Intramuscularly in Healthy Adult Volunteers

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.

Read the detailed description

MG1109 is purified, inactivated influenza viral antigen.

Conditions
Influenza
Being tested
MG1109, Placebo
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.

  • MG1109Biological

  • PlaceboBiological

Study groups in NCT01987011
Study groupRoleWhat they receive
MG1109ExperimentalMG1109 0.5 mL Intramuscularly injection, twice at an interval of 21 days
Receives: Biological: MG1109
PlaceboPlacebo comparatorPlacebo(for MG1109) 0.5 mL Intramuscularly injection, twice at an interval of 21 days
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects achieving post-vaccination Hemagglutination Inhibition(HI) antibody titer ≥ 1:40

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

  2. Percentage of subjects achieving post-vaccination seroconversion for Hemagglutination Inhibition(HI) antibody

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

  3. GMR(Geometric Mean Ratio) of Hemagglutination Inhibition(HI) antibody titer at post-vaccination compared to pre-vaccination

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

  4. The percentage of subjects reporting solicited adverse events from the date of vaccination until 7 days after each vaccination

    Measured: Each vaccination ~ 7 days after each vaccination

  5. The percentage of subjects reporting unsolicited adverse events from the date of 1st vaccination until 24weeks after 2nd vaccination

    Measured: 1st vaccination ~ 24 weeks after 2nd vaccination

Secondary outcomes (5)

  1. GMT(Geometric Mean Titer) of Hemagglutination Inhibition(HI) antibody titer pre-vaccination and post-vaccination

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

  2. GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio) of neutralizing antibody titer pre-vaccination and post-vaccination

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

  3. Vital signs(body temperature, pulse)

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

  4. The results of physical examinations

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

  5. Lab results(Hematology, Blood chemistry, Urinalysis)

    Measured: 1st vaccination ~ 21 days after 2nd vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionOct 2013
  4. Study completionMar 2014

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
420 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987011
Sponsor's protocol ID
MG1109_P3
Status last verified
Jul 2015
First submitted
22 Jul 2013
Last updated
3 Jul 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MG1109 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 3 Jul 2015. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 (time frame: 1st vaccination ~ 21 days after 2nd vaccination). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01987011.

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 3 Jul 2015.

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