NCT01750814

To Evaluate the Effectiveness(Immunogenicity) and Safety of 'GC3102C' Administered Intramuscularly in Healthy Adults

A Phase III, Randomized, Double-blind, Multi-center Study to Compare the Immunological Efficacy and Safety of GC3102C With GC FLU Inj. Administered Intramuscularly in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to demonstrate the immunological non-inferiority between GC3102C and GC FLU inj. influenza vaccines by assessing geometric mean titers(GMTs) in healthy adults

Conditions

• Prophylaxis Against Influenza

Interventions

Type	Name	Description
BIOLOGICAL	GC3102C	a single dose (0.5 mL) intramuscularly on the deltoid muscle
BIOLOGICAL	GC FLU inj.	a single dose (0.5 mL) intramuscularly on the deltoid muscle

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-12-17
• Last updated: 2016-01-15