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A Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children

NCT02541253 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2016-11-07

No results posted yet for this study

Summary

1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age.
2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the 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 drug 1 times or 2 times according to age as below;

* 6 m \~ 3 years
* 3 years \~ 9 years
* 9 years \~ 19 years

Conditions

Interventions

BIOLOGICAL

GC3110A

A single 0.5mL dose intramuscular injection

BIOLOGICAL

GCFLU Pre-filled Syringe inj.

A single 0.5mL dose intramuscular injection

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Jin-han Kang, Dr. · The Catholic Univ. of Korea Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-06-30
Completion
2016-06-30

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 NCT02541253 on ClinicalTrials.gov