Influenza, HumanPhase 1NCT03357263
A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults
A Phase 1 study testing GC3114 and GCFLU Quadrivalent in people with Influenza, Human, run by Green Cross Corporation at 1 site in South Korea.
Trial summary
Healthy adults 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 19 to 64 yearsHealthy 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
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2017to 22 Dec 2017
- Phase
- Phase 1
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 19-64 years old
- Informed consent form has been signed and dated
- Able to comply with the requirements of the study
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
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.
Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Read the detailed description
Healthy adults 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 |
| 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 (3)
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
Seroconversion rate (SCR)
Measured: Day 0 and Day 21
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Seroprotection rate (SPR)
Measured: Day 0 and Day 21
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination
Geometric Mean Titer(GMT), Geometric Mean Titer(GMT)
Measured: Day 0 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start20 Nov 2017
- Primary completion22 Dec 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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
- NCT03357263
- Sponsor's protocol ID
- GC3114_P1
- Status last verified
- Nov 2018
- First submitted
- 24 Nov 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noh JY, Jang YS, Lee SN, Choi MJ, Yoon JG, Yu DH, Song JY, Cheong HJ, Kim WJ. Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults. Vaccine. 2019 Aug 23;37(36):5171-5176. doi: 10.1016/j.vaccine.2019.07.076. Epub 2019 Jul 31.
PubMed 31377075
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.
- ClinicalTrials.gov ID
- NCT03357263
- Acronym / sponsor ID
- GC3114_P1
- Conditions
- Influenza, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 29 Nov 2017 (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.
Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..
Detailed description
Healthy adults 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
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC3114 | Experimental | Biological: GC3114Pre-filled syringe inj., 0.5ml, Once, IM |
| GCFLU Quadrivalent | Active comparator | Biological: GCFLU QuadrivalentPre-filled syringe inj., 0.5ml, Once, IM |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults aged 19-64 years old
- Informed consent form has been signed and dated
- Able to comply with the requirements of the study
Key exclusion criteria (6 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 | GCFLU Quadrivalent |
Primary outcome
Adverse Event
Time frame: for 7 days from Day0/during study period
Solicited/Unsolicited Adverse Event
3 secondary outcomes
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
Time frame: Day 0 and Day 21
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
Time frame: Day 0 and Day 21
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination
Time frame: Day 0 and Day 21
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 19 Nov 2018.
- Derived from this study: PubMed 31377075Noh JY, Jang YS, Lee SN, Choi MJ, Yoon JG, Yu DH, Song JY, Cheong HJ, Kim WJ. Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults. Vaccine. 2019 Aug 23;37(36):5171-5176. doi: 10.1016/j.vaccine.2019.07.076. Epub 2019 Jul 31.
- Individual participant dataSharing planned: No
Related trials for Influenza, Human
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingObservational study
Screening for LID Clinical Studies Unit Healthy Volunteer Protocols
Zika, Influenza
Enrolling by invitationObservational study
Long-term Observation of Hemagglutinin and Neuraminidase Inhibition Antibody Titers After Influenza Challenge
Post Influenza
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 1 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 3 inclusion and 6 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 19 Nov 2018. 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 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.
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?
On the ClinicalTrials.gov record for NCT03357263, which also lists 1 linked publication.
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 19 Nov 2018.