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
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.
- 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