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A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age

NCT03285997 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2017-09-18

No results posted yet for this study

Summary

If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, study subjects eligible for participating this trial protocol were assigned to test group or control group with the ratio of 4:1 and receiving the test or control drug 1 time or 2 times.

Conditions

  • Influenza Vaccine

Interventions

BIOLOGICAL

GC3110A

A single 0.5mL dose intramuscular injection

BIOLOGICAL

GCFLU Pre-filled syringe inj.

A single 0.25mL dose intramuscular injection

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-05-31
Completion
2018-08-31

Countries

  • South Korea

Study Locations

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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 NCT03285997 on ClinicalTrials.gov