NCT02249221

Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

A Randomized (Part B), Open-label (Part A) or Double-blind (Part B), Active-controlled (Part B) Phase I/IIa Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.

Detailed description

This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa to ensure participants protection. Part A is an open-label and single arm study in 9 healthy volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent cell-culture based influenza vaccin	GC3106, 0.5ml, intramuscular, a single dosing at Day 1
BIOLOGICAL	Trivalent influenza vaccine	GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Timeline

• Start date: 2014-10-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2014-09-25
• Last updated: 2014-12-05

Locations

1 site across 1 country: South Korea