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

Phase 3

• Conditions: Influenza, Human
• Interventions: Biological: GC3110B vaccine; Biological: GCFLU Quadrivalent Inj. vaccine

• Registration Number: NCT02915809
• Lead Sponsor: Green Cross Corporation

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.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-25
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-27
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-29
• Study Start: 2016-10
• Primary Completion: 2016-12
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 414

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GC3110B Vaccine Group	GC3110B vaccine	Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine).
GCFLU Quadrivalent Inj.	GCFLU Quadrivalent Inj. vaccine	Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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.