A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Elderly Healthy Subjects

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03657719

Enrollment

105

Registered

2018-09-05

Start date

2018-10-01

Completion date

2018-12-13

Last updated

2019-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Human

Brief summary

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.

Interventions

BIOLOGICALGC3114

High-dose Quadrivalent influenza vaccine

BIOLOGICALGCFLU Quadrivalent

Quadrivalent influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Masking description

Part 1 : Open label, Part 2 : Double blind

Intervention model description

Part 1 : Single group, Part2 : Parallel group

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults aged over 65 years old * Informed consent form has been signed and dated

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Adverse Event	for 7 days from Day0/during study period	Solicited/Unsolicited Adverse Event

Secondary

Measure	Time frame	Description
Percentage of participants achieving pre-defined Seroconversion Before and following vaccination	Day 0 and Day 28	Seroconversion rate (SCR)
Percentage of participants achieving pre-defined Seroprotection Before and following vaccination	Day 0 and Day 28	Seroprotection rate (SPR)
Geometric Mean Titer of Antibodies to the Investigational Product Before and Following vaccination	Day 0 and Day 28	Geometric Mean Titer(GMT)
Geometric Mean Ratio of Antibodies to the Investigational Product Before and Following vaccination	Day 0 and Day 28	Geometric Mean Ratio(GMR)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026