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InfluenzaPhase 3NCT02658409

A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study

A Phase 3 study testing GC3106(quadrivalent cell-culture based influenza vaccine) and Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine) in people with Influenza, run by Green Cross Corporation at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
GC3106(quadrivalent cell-culture based influenza vaccine) and Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,630 participants
Where
1 siteSouth Korea
Study dates
Nov 2015to Nov 2015
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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Given written informed consent
  • Healthy Korean adults (age: between over 19)
  • Women of childbearing age with negative Urine hCG in screening visit

Who cannot join

  • Subjects unable to communicate (illiterate or who cannot understand the questionnaire and/or the study subject diary)
  • Subjects participating in another clinical study or has participated in a clinical study in the last 30 days (the participation should be based on the final dose of the investigational drug)
  • Subjects with impaired immune functions that include immune deficiency diseases
  • Subjects with a history of Guillain-Barre syndrome
  • Hemophilia patients at risk of serious bleeding with intramuscular injection or who had taken an anticoagulant
  • Subjects with symptoms of active infection or who had higher than 38.0℃ fever before the investigational product administration
Show all 16Show fewer
  • Subjects to be planned to have a surgery in the study duration or subject who the investigator decides exception because of a clinical significant chronic or malignant disease or medical history to interrupt the study procedure
  • Subjects with erythema and/or a tattoo in the injection site of the scheduled investigational product (the deltoid muscle) that is hard to identify the topical toxicity
  • Subjects with a history of allergic reaction to eggs or chicken, the vaccine components, and/or Formaldehyed, Gentamicin and Sodium Deoxychloate
  • Subjects who had been administered the influenza vaccine 6 months before the scheduled vaccination of the investigational product
  • Subjects who had been vaccinated with another vaccine within 30 days before the investigational product administration or had a scheduled vaccination during the clinical study period
  • Subjects who had received an immunosuppressant, immunity-modifying drug, cytotoxic chemotherapy that can affect his or her immune system, or radiation therapy within 3 months before the investigational product administration
  • Subjects receiving systemic steroids (more than 20 mg/day of prednisolone administered everyday over 14 days or more than 700 mg of a cumulative dose during the same period of time) within 3 months before the administration (Day 1) of the investigational product (topical ointments, eye drops, inhalants or intranasally/intramuscularly administered drugs, or topically applied drugs such as ligaments; unless administered every other day over 14 days)
  • Subjects who had received immunoglobulin or a blood-derived product within 3 months before being vaccinated with the investigational product or is scheduled to receive those products during the clinical study period
  • Pregnant women, nursing mothers, or women of childbearing age who do not perform adequate contraception (using a condom, diaphragm, IUD, or hormonal contraception 21 days before vaccination with the investigational product or whose male partner had undergone a vasectomy)
  • Subjects who have other clinically significant medical or psychiatric examination findings deemed by the investigator to make them ineligible for participation in this clinical study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.

Read the detailed description

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study to Investigate the Efficacy (Immunogenicity) and Safety of GC3106 (quadrivalent cell-culture based influenza vaccine) after Intramuscular Administration in Healthy Subjects.

Conditions
Influenza
Being tested
GC3106(quadrivalent cell-culture based influenza vaccine), Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)
Keywords
CCIV, quadrivalent cell-culture based influenza vaccine, Influenza vaccine, Vaccination
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GC3106(quadrivalent cell-culture based influenza vaccine)Biological

    Also called GC3106

    GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1

  • Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)Biological

    Also called Fluarix™tetra Syringe Inj.

    Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Study groups in NCT02658409
Study groupRoleWhat they receive
GC3106(quadrivalent)Experimental0.5ml, intramuscular, a single dosing
Receives: Biological: GC3106(quadrivalent cell-culture based influenza vaccine)
Fluarix™tetra Syringe Inj.(Quadrivalent)Active comparator0.5ml,intramuscular,a single dosing
Receives: Biological: Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)

What is being measured

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

  1. The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio

    (GMT control drug/ GMT test drug)

    Measured: Day 21 post vaccination

  2. The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the difference between the SCRs

    (SCR control drug- SPR test drug)

    Measured: Day 21 post vaccination

  3. Solicited adverse events: Day 0~Day 6

    Measured: Day 0~Day 6

  4. Unsolicited adverse events: Day 0~Day 21

    Measured: Day 0~Day 21

Secondary outcomes (4)

  1. Rate of subjects achieving seroconversion, defined as post vaccination HI antibody titers

    Measured: 21 days after vaccination

  2. Rate of subjects achieving seroprotection, defined as post vaccination HI antibody titers

    Measured: 21 days after vaccination

  3. Vital sign and physical examination

    Measured: For 180 days after Visit 1

  4. For 180 days after Visit 1, serious adverse events were presented with the results.

    Measured: For 180 days after Visit 1

Timeline

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

  1. First posted18 Jan 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionNov 2015

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02658409
Sponsor's protocol ID
GC3106_AD_P3
Status last verified
Jan 2016
First submitted
6 Dec 2015
Last updated
26 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GC3106(quadrivalent cell-culture based influenza vaccine) and Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine) in people with Influenza, run by Green Cross Corporation at 1 site 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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

Results are not available in the source record.

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?

The effect of the vaccination after 21 days of hemagglutination inhibition antibody (HI antibody) titer was measured through the GMT ratio (time frame: Day 21 post vaccination). The study lists 4 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 NCT02658409.

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 26 Feb 2016.

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Clinical Trial NCT02658409 | AzTrials