A Phase 2/3 interventional study of vaccination of GC3114B and Vaccination of Efluelda in Influenza A, Influenza B and Influenza Vaccination, sponsored by GC Biopharma Corp. Not yet recruiting at 1 site in South Korea. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by GC Biopharma Corp · Phase 2/3, Interventional, and Prevention
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.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's planned enrollment of 1,806 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →GC Biopharma Corp is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
inactivated, split influenza vaccine
Biological: vaccination of GC3114B
Inactivated split influenza vaccine
Biological: Vaccination of Efluelda
influenza vaccination
influenza vaccination
Evaluation of the immunogenicity of GC3114B
HI antibody
Time frame: Day 28 following IP vaccination
Evaluation of the safety of GC3114B
Solicited AE
Time frame: Day 7 following IP vaccination
Evaluation of the safety of GC3114B
Unsolicited AE
Time frame: Day 28 following IP vaccination
Evaluation the safety of GC3114B
SAE
Time frame: 6 months following IP vaccination
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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