A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02915809

Enrollment

414

Registered

2016-09-27

Start date

2016-10-31

Completion date

2017-05-31

Last updated

2016-09-29

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

Conditions

Influenza, Human

Keywords

Influenza Vaccines

Brief summary

The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.

Detailed description

Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

Interventions

BIOLOGICALGC3110B vaccine

0.5mL, Intramuscular

BIOLOGICALGCFLU Quadrivalent Inj. vaccine

0.5mL, Intramuscular

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults aged 18 to 60 years * 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-Barré syndrome * 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
Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Seroconversion is defined as either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥ 1: 40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.
Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination	Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)	Antibodies will be assessed using the hemagglutination inhibition (HI) assay. Seroprotection is defined as a titer ≥1:40 at pre-vaccination and 21 days after vaccination.
Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination	Day 0 to Day 6	—
Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination	Day 0 to Day 21	—

Outcome results

None listed

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