NCT02352584

A Multicenter, Double-blind, Parallel Phase III Study

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,299 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III

Detailed description

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Efficacy(Immunogenicity) and Safety of GC3110A(Quadrivalent Influenza Vaccine) After Intramuscular Administration in Healthy Subjects

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	GC3110A(Quadrivalent)	GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
BIOLOGICAL	GC Flu(Trivalent)	GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
BIOLOGICAL	GC3110A(Trivalent)	GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-12-01
• Completion: 2015-07-01
• First posted: 2015-02-02
• Last updated: 2015-10-20

Locations

1 site across 1 country: South Korea