Back to results

Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents

Primary Purpose

Influenza, Human

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

IL-YANG Quadrivalent Influenza Vaccine

IL-YANG Flu Vaccine Pre-filled Syringe

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy men or women aged from 3 years to < 19 years
Subjects were born after full term pregnancy (37 weeks)
Woman of childbearing potential must have a negative result from Urine Human Chorionic Gonadotropin(HCG) test at the screening visit.
Voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 7 years of age)

Exclusion Criteria:

Subject with a known serious allergy reaction after influenza vaccination or to any component vaccine including eggs
Subject who had received an influenza vaccine within the last 6 months
Subject who has, or has a family history of, an immune system disorder including immune deficiency disease
Subject with a history of Guillain-Barre syndrome
Subject with Down's syndrome or cytogenetic disorders.
Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial
Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
Subject who had an acute fever with body temperature > 38.0 Cº within 72 hours prior to administration of the study vaccine
Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period.
Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine
Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study.
Subject who had participated in another experimental study within 28 days prior to administration of the study vaccine
Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.

Sites / Locations

The catholic university of Korea, Seoul ST. Marry's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IL-YANG Quadrivalent Influenza Vaccine

IL-YANG Flu Vaccine Pre-filled Syringe

Arm Description

The vaccine contains both B strain (Yamagata, Victoria)

The vaccine contains the B/Yamagata strain and it was approved for commercial sale by Ministry of Food and Drug Safety.

Outcomes

Primary Outcome Measures

Seroconversion rate against Hemagglutination Inhibition(HI) antibody

Seroconversion rate(a lower bound of 95 CI) ≥ 40%

Seroprotection rate against Hemagglutination

Seroprotection rate(a lower bound of 95 CI) ≥ 70%

Secondary Outcome Measures

Geometric Mean Titer(GMT) and Geometric Mean Ratio(GMR)

GMT and GMR of HI Antibody Titer Before Vaccination and After Vaccination

Full Information

NCT ID

NCT03445468

First Posted

August 8, 2017

Last Updated

May 7, 2020

Sponsor

Il-Yang Pharm. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03445468

Brief Title

Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents

Official Title

Phase III Study to Evaluate Immunogenicity and Safety of 'Il-Yang Quadrivalent Seasonal Influenza Vaccine' in Healthy Korean Children and Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

September 20, 2017 (Actual)

Primary Completion Date

December 29, 2017 (Actual)

Study Completion Date

August 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Il-Yang Pharm. Co., Ltd.

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

The purpose of this study is to evaluate the immunogenicity and safety of 'IL-YANG Quadrivalent Seasonal Influenza Vaccine' in healthy Korean children and adolescents.

Detailed Description

The study is an open-label(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active comparator(Part 2) Phase III study. Before initiation of any protocol-specific activities, written informed consent is obtained from each patient and their legally acceptable representatives. Subjects who meet all of the eligibility criteria after screening assessments as specified in the protocol, are randomized into the test group or the comparator group in a ratio of 4 :1 and receive a single dose or two doses of the study vaccine. The investigator perform the efficacy (immunogenicity) and safety assessments throughout the study. Efficacy data are collected at Visit 1 (prior to vaccination) and at the end-of-study visit for efficacy (immunogenicity) assessments, and for safety assessment, subjects and their legally acceptable representatives are instructed to record any treatment-emergent adverse event in Patient Diary cards. For all randomized subjects, blood sample is obtained prior to vaccination, and the study vaccine 0.5mL is administered. For children aged from 3 years to <9 years of age who have not previously received influenza vaccine, another dose of the study vaccine is administered 4 to 5 weeks after the first dose. Blood samples are collected 4 to 5 weeks after the last dose of the study drug for the assessment of antibody titer. All subjects are followed for 6 months after the last dose of the study drug for the safety assessments, and Month 6 follow-up visit is the end-of-study visit.

6. Conditions and Keywords

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

Influenza, Human

Keywords

Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

379 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IL-YANG Quadrivalent Influenza Vaccine

Arm Type

Experimental

Arm Description

The vaccine contains both B strain (Yamagata, Victoria)

Arm Title

IL-YANG Flu Vaccine Pre-filled Syringe

Arm Type

Active Comparator

Arm Description

The vaccine contains the B/Yamagata strain and it was approved for commercial sale by Ministry of Food and Drug Safety.

Intervention Type

Biological

Intervention Name(s)

IL-YANG Quadrivalent Influenza Vaccine

Intervention Description

A single 0.5mL dose administrated as an intramuscular injection.

Intervention Type

Biological

Intervention Name(s)

IL-YANG Flu Vaccine Pre-filled Syringe

Intervention Description

A single 0.5mL dose administrated as an intramuscular injection.

Primary Outcome Measure Information:

Title

Seroconversion rate against Hemagglutination Inhibition(HI) antibody

Description

Seroconversion rate(a lower bound of 95 CI) ≥ 40%

Time Frame

Up to Day28(+7) after the last vaccination

Title

Seroprotection rate against Hemagglutination

Description

Seroprotection rate(a lower bound of 95 CI) ≥ 70%

Time Frame

Up to Day28(+7) after the last vaccination

Secondary Outcome Measure Information:

Title

Geometric Mean Titer(GMT) and Geometric Mean Ratio(GMR)

Description

GMT and GMR of HI Antibody Titer Before Vaccination and After Vaccination

Time Frame

Up to Day28(+7) after the last vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy men or women aged from 3 years to < 19 years Subjects were born after full term pregnancy (37 weeks) Woman of childbearing potential must have a negative result from Urine Human Chorionic Gonadotropin(HCG) test at the screening visit. Voluntary written informed consent was obtained from the subject and the subject's legally acceptable representative (consent of legally acceptable representative was required for subjects younger than 7 years of age) Exclusion Criteria: Subject with a known serious allergy reaction after influenza vaccination or to any component vaccine including eggs Subject who had received an influenza vaccine within the last 6 months Subject who has, or has a family history of, an immune system disorder including immune deficiency disease Subject with a history of Guillain-Barre syndrome Subject with Down's syndrome or cytogenetic disorders. Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial Subject with hemophilia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection Subject who had an acute fever with body temperature > 38.0 Cº within 72 hours prior to administration of the study vaccine Subject who had previously received another vaccine within 28 days before administration of the study drug, or is scheduled to receive another vaccine during the study period. Subject who had received immunosuppressant or immune modifying drug within the last 3 months prior to administration of the study vaccine Subject who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or is expecting to be treated with immunoglobulin or blood-derived products during the study. Subject who had participated in another experimental study within 28 days prior to administration of the study vaccine Subject with other clinically significant medical or psychological condition who in the investigator's opinion would not be suitable for the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin-Han Kang, MD.PhD

Organizational Affiliation

The catholic university of Korea, Seoul ST. Marry's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The catholic university of Korea, Seoul ST. Marry's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents

We'll reach out to this number within 24 hrs