A Study to Evaluate the Efficacy & Safety of GC3110A in Healthy Infants

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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

2. Part 2 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.

The investigator will evaluate the efficacy and safety of the test product while clinical trial.

Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation. The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety.

At visit1, blood samples will be collected from randomized study subjects and investigational drug will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, will re-visit and have the 2nd vaccination, 4~5 weeks after the 1st vaccination.

After 4~5 weeks since last vaccination, study subjects will visit and blood sample will be collected. And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit.

The study subjects with 1 dose of vaccine will have 4 visits including Visit 1~2 and Visit 5~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 3~4. ;

Study Design

Related Conditions & MeSH terms

Influenza Vaccine

Clinical Trial Details

NCT number	NCT03285997
Study type	Interventional
Source	Green Cross Corporation
Contact	Han-A Cha
Phone	+82-260-1936
Email	hacha@greencross.com
Status	Not yet recruiting
Phase	Phase 3
Start date	September 30, 2017
Completion date	August 31, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms