NCT03285997

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Influenza Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	GC3110A	A single 0.5mL dose intramuscular injection
BIOLOGICAL	GCFLU Pre-filled syringe inj.	A single 0.25mL dose intramuscular injection

Timeline

• Start date: 2017-09-30
• Primary completion: 2018-05-31
• Completion: 2018-08-31
• First posted: 2017-09-18
• Last updated: 2017-09-18

Locations

1 site across 1 country: South Korea