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

Phase 2

Completed

• Conditions: Influenza, Human
• Interventions: Biological: GCFLU Quadrivalent; Biological: GC3114

• Registration Number: NCT03657719
• Lead Sponsor: Green Cross Corporation

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.

Study Timeline

• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-09-01
• Study First Posted: 2018-09-05
• Study Start: 2018-10-01
• Primary Completion: 2018-12-13
• Study Completion: 2018-12-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: GCFLU Quadrivalent	GCFLU Quadrivalent	Pre-filled syringe inj., 0.5ml, Once, IM
GC3114	GC3114	Pre-filled syringe inj., 0.5ml, Once, IM

Primary Outcome Measures

Name	Time	Method
Adverse Event	for 7 days from Day0/during study period	Solicited/Unsolicited Adverse Event

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of