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

NCT01750814 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-01-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

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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 NCT01750814 on ClinicalTrials.gov