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A Multicenter, Double-blind, Parallel, Non-inferiority, Phase III Study

NCT02658409 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1630

Last updated 2016-02-26

No results posted yet for this study

Summary

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Non-inferiority, Phase III Study.

Conditions

Interventions

BIOLOGICAL

GC3106(quadrivalent cell-culture based influenza vaccine)

GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1

BIOLOGICAL

Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)

Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Lee Jin Su, M.D · Inha University Hospital

  • Choi Won Seck, M.D · Korea University Ansan Hospital

  • Lee Ja Cob · Hallym Univ. Medical Center

  • Woo Heong Jung · Hallym Univ. Medical Center

  • Wi Sung Heon · St Vincent's Hospital

  • Jeong Suk In · Chonnam Natinal University Hospital

  • Kim Sin Woo · Kyungpook National University Hospital

  • Kim Tae Hyung · Soon Chun Hyang Univ. Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2015-11-30

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 NCT02658409 on ClinicalTrials.gov