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

NCT02249221 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-12-05

No results posted yet for this study

Summary

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

Conditions

Interventions

BIOLOGICAL

Trivalent influenza vaccine

GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

BIOLOGICAL

Quadrivalent cell-culture based influenza vaccin

GC3106, 0.5ml, intramuscular, a single dosing at Day 1

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Woo Joo KIM, M.D., Ph.D · Korea University Guro Hospital

  • Chang-Hee LEE, M.D. · Green Cross Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02249221 on ClinicalTrials.gov