A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Subjects Aged 65 Years and Older

A Multicenter, Open-label, Single Arm Study to Evaluate the Immunological Efficacy and Safety of GC3110A. Administered Intramuscularly in Healthy Subjects Aged 65 Years and Older

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02917304

Enrollment

274

Registered

2016-09-28

Start date

2016-10-10

Completion date

2017-05-08

Last updated

2017-05-30

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

Conditions

Influenza, Human

Keywords

Quadrivalent Influenza Vaccines

Brief summary

The purpose of this study is to evaluate immunological efficacy and safety of GC3110A among healthy adults over 65 years of age.

Detailed description

Adults over 65 years of age will be once administered GC3110A(Quadrivalent influenza vaccine).

Interventions

BIOLOGICALGC3110A vaccine

0.5mL, Intramuscular

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults aged 65 years and older * Informed consent form has been signed and dated * Able to comply with the requirements of the study

Exclusion criteria

* Known systemic hypersensitivity 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
Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Percentage of Participants Achieving Pre-defined Seroconversion Before and following vaccination
Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Percentage of Participants Achieving Pre-defined Seroprotection Before and following vaccination

Secondary

Measure	Time frame	Description
Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the GC3110A Before and Following Vaccination

Countries

South Korea

Outcome results

None listed

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