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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

Primary Purpose

Influenza Vaccine

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

GC3110A

GCFLU Pre-filled syringe inj.

About this trial

This is an interventional prevention trial for Influenza Vaccine focused on measuring Quadrivalent Influenza Vaccines

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

The Catholic Univ.of Korea Seoul St.Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GC3110A

GCFLU Pre-filled syringe inj.

Arm Description

One injection: Day 0 Two injection: Day 0 and Day 28

Outcomes

Primary Outcome Measures

Seroconversion rate for HI antibody after final injection

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

Secondary Outcome Measures

GMT

GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)

GMR

GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)

Full Information

NCT ID

NCT03285997

First Posted

September 13, 2017

Last Updated

September 15, 2017

Sponsor

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03285997

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 30, 2017 (Anticipated)

Primary Completion Date

May 31, 2018 (Anticipated)

Study Completion Date

August 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Vaccine

Keywords

Quadrivalent Influenza Vaccines

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GC3110A

Arm Type

Experimental

Arm Description

One injection: Day 0 Two injection: Day 0 and Day 28

Arm Title

GCFLU Pre-filled syringe inj.

Arm Type

Active Comparator

Arm Description

One injection: Day 0 Two injection: Day 0 and Day 28

Intervention Type

Biological

Intervention Name(s)

GC3110A

Intervention Description

A single 0.5mL dose intramuscular injection

Intervention Type

Biological

Intervention Name(s)

GCFLU Pre-filled syringe inj.

Intervention Description

A single 0.25mL dose intramuscular injection

Primary Outcome Measure Information:

Title

Seroconversion rate for HI antibody after final injection

Description

Time Frame

Post-vaccination (Day 28 or 56)

Title

Seroprotection rate for HI antibody after final injection

Time Frame

Post-vaccination (Day 28 or 56)

Secondary Outcome Measure Information:

Title

GMT

Description

GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)

Time Frame

Post-vaccination (Day 28 or 56)

Title

GMR

Description

GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)

Time Frame

Post-vaccination (Day 28 or 56)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

35 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy infants aged 6 month to 3 years. Study subject was born at full term pregnancy(37 week) Study subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form Exclusion Criteria: Those with a history of allergic reaction to eggs or chicken, the vaccine components Those who had been ad ministered the influenza vaccine 6 months prior to the study drug vaccination Those with immunologic impairment including immune deficiency disorders or family history about it. Those with a history of Guillain-Barre syndrome Those with a history of Down's syndrome or cytogenetic disorders Those who would be ineligible to participate the study as follows: serious chronic disease Hemophilia patients at risk of serious bleeding with intramuscular injection or those receiving anticoagulant therapy Those who have active infection or who have fever higher than 38.0℃ within 72 hours prior to the dosing of study drug 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 Those who had received an immunosuppressant, immunity-modifying drug within 3 months prior to the dosing of study drug 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 Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4 hours prior to the dosing of study drug Study subject who had participated in other clinical trial within 28 days prior to the study vaccination

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Han-A Cha

Phone

+82-260-1936

hacha@greencross.com

Facility Information:

Facility Name

The Catholic Univ.of Korea Seoul St.Mary's Hospital

City

Seoul

Country

Korea, Republic of

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Han Kang, M.D.PhD

First Name & Middle Initial & Last Name & Degree

Jin Han Kang, M.D.PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33736920

Citation

Choi UY, Kim KH, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Song SE, Jo DS, Lee J, Ma SH, Kim KN, Kang JH. Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months. Vaccine. 2021 Apr 8;39(15):2103-2109. doi: 10.1016/j.vaccine.2021.03.005. Epub 2021 Mar 16.

Results Reference

derived

Learn more about this trial

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

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