Influenza, HumanPhase 2NCT03657719
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
A Phase 2 study testing GC3114 and GCFLU Quadrivalent in people with Influenza, Human, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- GC3114 and GCFLU Quadrivalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 13 Dec 2018
- Phase
- Phase 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy adults aged over 65 years old
- Informed consent form has been signed and dated
Who cannot join
- Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
- Personal history of Guillain-Barre syndrome(GBS)
- Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
- Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Read the detailed description
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Safety and immunological efficacy will be evaluated.
- Conditions
- Influenza, Human
- Being tested
- GC3114, GCFLU Quadrivalent
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC3114Biological
High-dose Quadrivalent influenza vaccine
GCFLU QuadrivalentBiological
Quadrivalent influenza vaccine
| Study group | Role | What they receive |
|---|---|---|
| GC3114 | Experimental | Pre-filled syringe inj., 0.5ml, Once, IM Receives: Biological: GC3114 |
| Active Comparator: GCFLU Quadrivalent | Active comparator | Pre-filled syringe inj., 0.5ml, Once, IM Receives: Biological: GCFLU Quadrivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event
Solicited/Unsolicited Adverse Event
Measured: for 7 days from Day0/during study period
Secondary outcomes (4)
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
Seroconversion rate (SCR)
Measured: Day 0 and Day 28
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Seroprotection rate (SPR)
Measured: Day 0 and Day 28
Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination
Geometric Mean Titer(GMT)
Measured: Day 0 and Day 28
Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination
Geometric Mean Ratio(GMR)
Measured: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Oct 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 : Single group, Part2 : Parallel group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woo Joo KIm, M.D, Ph.D, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657719
- Sponsor's protocol ID
- GC3114_P2
- Status last verified
- Jan 2019
- First submitted
- 27 Aug 2018
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-labeled(Part 1), Single-group(Part 2), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Pharse II Clinical Trial to Evaluate Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects
- ClinicalTrials.gov ID
- NCT03657719
- Acronym / sponsor ID
- GC3114_P2
- Conditions
- Influenza, Human
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 5 Sep 2018 (actual)
- 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.
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Detailed description
Elderly healthy subjects will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Safety and immunological efficacy will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Part 1 : Single group, Part2 : Parallel group
| Arm | Type | Receives |
|---|---|---|
| GC3114 | Experimental | Biological: GC3114Pre-filled syringe inj., 0.5ml, Once, IM |
| Active Comparator: GCFLU Quadrivalent | Active comparator | Biological: GCFLU QuadrivalentPre-filled syringe inj., 0.5ml, Once, IM |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Healthy adults aged over 65 years old
- Informed consent form has been signed and dated
Key exclusion criteria (5 listed)
- Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
- Personal history of Guillain-Barre syndrome(GBS)
- Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
- Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
- Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
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 |
|---|---|---|
| GC3114High-dose Quadrivalent influenza vaccine | Biological | GC3114 |
| GCFLU QuadrivalentQuadrivalent influenza vaccine | Biological | Active Comparator: GCFLU Quadrivalent |
Primary outcome
Adverse Event
Time frame: for 7 days from Day0/during study period
Solicited/Unsolicited Adverse Event
4 secondary outcomes
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
Time frame: Day 0 and Day 28
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Time frame: Day 0 and Day 28
Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination
Time frame: Day 0 and Day 28
Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination
Time frame: Day 0 and Day 28
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 4 Jan 2019.
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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, M.D, Ph.D principal investigator
Korea University Guro Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GC3114 and GCFLU Quadrivalent in people with Influenza, Human, 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 2 inclusion and 5 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 4 Jan 2019. 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 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?
Adverse Event (time frame: for 7 days from Day0/during study period). 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 4 Jan 2019.