Influenza A, Influenza BPhase 2/3GC3114BNCT07883928
Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older
A Phase 2/3 study testing vaccination of GC3114B and Vaccination of Efluelda in people with Influenza A, Influenza B and Influenza Vaccination, run by GC Biopharma Corp at 1 site in South Korea.
Trial summary
This is a multicenter, randomized, double-blind, active-controlled, parallel-group clinical trial in adults aged 65 years or older. The study will evaluate the safety of GC3114B and assess whether its immune response is non-inferior to that of the active control. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza A, Influenza B, Influenza Vaccination
- What is being tested?
- vaccination of GC3114B and Vaccination of Efluelda
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,806 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2026to Aug 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Adults aged 65 years or older at the time of IP vaccination
- Subjects who have voluntarily decided to participate in the study after receiving and understanding a detailed explanation of the study and provided written informed consent to comply with the precautions
Who cannot join
- History of severe hypersensitivity reactions after previous influenza vaccination or to eggs or any component of the vaccine (see Section 6.1) (e.g., anaphylaxis)
- Record of an influenza vaccination within 24 weeks prior to IP vaccination
- Known or suspected history of impaired immune function, including congenital or acquired immunodeficiency disorders
- History or family history of Guillain-Barre syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older
This is a multicenter, randomized, double-blind, active-controlled, parallel-group clinical trial in adults aged 65 years or older. The study will evaluate the safety of GC3114B and assess whether its immune response is non-inferior to that of the active control.
After providing written informed consent, participants will undergo screening to determine whether they are eligible. Eligible participants will be randomly assigned to a study group and receive a single dose of the investigational product on Day 0.
Participants will record solicited adverse events in a subject diary from Day 0 through Day 7. The study site will contact participants by telephone on Day 7 to check on adverse events, concomitant medications, and diary completion. On Day 28, participants will visit the study site for safety follow-up and blood sampling. Participants will be monitored for serious adverse events for 6 months.
- Conditions
- Influenza A, Influenza B, Influenza Vaccination
- Being tested
- vaccination of GC3114B, Vaccination of Efluelda
- Keywords
- influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccination of GC3114BBiological
influenza vaccination
Vaccination of EflueldaBiological
influenza vaccination
| Study group | Role | What they receive |
|---|---|---|
| GC3114B | Experimental | inactivated, split influenza vaccine Receives: Biological: vaccination of GC3114B |
| Efluelda | Active comparator | Inactivated split influenza vaccine Receives: Biological: Vaccination of Efluelda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the immunogenicity of GC3114B
HI antibody
Measured: Day 28 following IP vaccination
Secondary outcomes (3)
Evaluation of the safety of GC3114B
Solicited AE
Measured: Day 7 following IP vaccination
Evaluation of the safety of GC3114B
Unsolicited AE
Measured: Day 28 following IP vaccination
Evaluation the safety of GC3114B
SAE
Measured: 6 months following IP vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza A, Influenza BStudies of the same condition, open and under way.
- More trials run by GC Biopharma CorpThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,806 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GC Biopharma Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883928
- Sponsor's protocol ID
- GC3114B_TIVHD_P2301
- Acronym
- GC3114B
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older
- ClinicalTrials.gov ID
- NCT07883928
- Acronym / sponsor ID
- GC3114B / GC3114B_TIVHD_P2301
- Conditions
- Influenza A, Influenza B, Influenza Vaccination
- Keywords
- influenza vaccine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,806 participants (estimated)
- Lead sponsor
- GC Biopharma CorpIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Oct 2026 (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.
This is a multicenter, randomized, double-blind, active-controlled, parallel-group clinical trial in adults aged 65 years or older. The study will evaluate the safety of GC3114B and assess whether its immune response is non-inferior to that of the active control.
After providing written informed consent, participants will undergo screening to determine whether they are eligible. Eligible participants will be randomly assigned to a study group and receive a single dose of the investigational product on Day 0.
Participants will record solicited adverse events in a subject diary from Day 0 through Day 7. The study site will contact participants by telephone on Day 7 to check on adverse events, concomitant medications, and diary completion. On Day 28, participants will visit the study site for safety follow-up and blood sampling. Participants will be monitored for serious adverse events for 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC3114B | Experimental | Biological: vaccination of GC3114Binactivated, split influenza vaccine |
| Efluelda | Active comparator | Biological: Vaccination of EflueldaInactivated split influenza vaccine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Adults aged 65 years or older at the time of IP vaccination
- Subjects who have voluntarily decided to participate in the study after receiving and understanding a detailed explanation of the study and provided written informed consent to comply with the precautions
Key exclusion criteria (4 listed)
- History of severe hypersensitivity reactions after previous influenza vaccination or to eggs or any component of the vaccine (see Section 6.1) (e.g., anaphylaxis)
- Record of an influenza vaccination within 24 weeks prior to IP vaccination
- Known or suspected history of impaired immune function, including congenital or acquired immunodeficiency disorders
- History or family history of Guillain-Barre syndrome
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 |
|---|---|---|
| vaccination of GC3114Binfluenza vaccination | Biological | GC3114B |
| Vaccination of Eflueldainfluenza vaccination | Biological | Efluelda |
Primary outcome
Evaluation of the immunogenicity of GC3114B
Time frame: Day 28 following IP vaccination
HI antibody
3 secondary outcomes
Evaluation of the safety of GC3114B
Time frame: Day 7 following IP vaccination
Evaluation of the safety of GC3114B
Time frame: Day 28 following IP vaccination
Evaluation the safety of GC3114B
Time frame: 6 months following IP vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vaccination of GC3114B and Vaccination of Efluelda in people with Influenza A, Influenza B and Influenza Vaccination, run by GC Biopharma Corp 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 4 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: opening soon, as of the sponsor's last update on 20 Oct 2026. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayoung Lee (+82-31-260-9369, CD2_GC3114B@gccorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the immunogenicity of GC3114B (time frame: Day 28 following IP vaccination). 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 20 Oct 2026.