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

Phase 3

• Conditions: Influenza Vaccine

• Registration Number: NCT03285997
• Lead Sponsor: Green Cross Corporation

Brief 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.

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-15
• Last Update Submitted: 2017-09-15
• Study First Posted: 2017-09-18
• Last Update Posted: 2017-09-18
• Study Start: 2017-09-30
• Primary Completion: 2018-05-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. Healthy infants aged 6 month to 3 years.
2. Study subject was born at full term pregnancy(37 week)
3. Study subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form

Exclusion Criteria

1. Those with a history of allergic reaction to eggs or chicken, the vaccine components
2. Those who had been ad ministered the influenza vaccine 6 months prior to the study drug vaccination
3. Those with immunologic impairment including immune deficiency disorders or family history about it.
4. Those with a history of Guillain-Barre syndrome
5. Those with a history of Down's syndrome or cytogenetic disorders
6. Those who would be ineligible to participate the study as follows: serious chronic disease
7. Hemophilia patients at risk of serious bleeding with intramuscular injection or those receiving anticoagulant therapy
8. Those who have active infection or who have fever higher than 38.0℃ within 72 hours prior to the dosing of study drug
9. Those who had been vaccinated with another vaccine within 28 days prior to the dosing of study drug or had a scheduled vaccination during the clinical trial period
10. Those who had received an immunosuppressant, immunity-modifying drug within 3 months prior to the dosing of study drug
11. Those who had received immunoglobulin or a blood-derived product within 3 months prior to the dosing of study drug or is scheduled to receive those products during the study period
12. Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4 hours prior to the dosing of study drug
13. Study subject who had participated in other clinical trial within 28 days prior to the study vaccination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seroconversion rate for HI antibody after final injection	Post-vaccination (Day 28 or 56)	the percentage of study subjects with a pre-vaccination (Day 0) HI titer\<1:10 and post-vaccination (Day 28) HI antibody titer≥1:40(Case1), or the percentage of study subjects with a pre-vaccination HI antibody titer≥1:10 and a minimum four-fold rise in post-vaccination HI antibody titer(Case 2)
Seroprotection rate for HI antibody after final injection	Post-vaccination (Day 28 or 56)

Secondary Outcome Measures

Name	Time	Method
GMT	Post-vaccination (Day 28 or 56)	GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)
GMR	Post-vaccination (Day 28 or 56)	GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)

Trial Locations

Locations (1)

The Catholic Univ.of Korea Seoul St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of