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Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants

Primary Purpose

Healthy

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Fluarix Tetra Pre-filled Syringe

About this trial

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

Eligibility Criteria

6 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy men or women aged from 6 months to < 3 years
Subjects were born after full term pregnancy (37 weeks)
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 10 years of age (and for subjects younger than 7 years of age for the some institutions)).

Exclusion Criteria:

Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine
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 30 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IL-YANG PFS

GSK PFS

Arm Description

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Fluarix Tetra Pre-filled Syringe

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)

GMT of HI Antibody Titer Before Vaccination and After Vaccination

Geometric Mean Ratio(GMR)

GMR of HI Antibody Titer Before Vaccination and After Vaccination

Full Information

NCT ID

NCT04381689

First Posted

May 6, 2020

Last Updated

October 12, 2023

Sponsor

Il-Yang Pharm. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04381689

Brief Title

Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants

Official Title

Phase Ⅲ, Randomized, Double-blind, Active Controlled to Evaluate the Immunogenicity and Safety of "IL-YANG Quadrivalent Seasonal Influenza Vaccine" in Healthy Infants From 6 Months to Under 3 Years of Age(≥ 6 Months and < 3 Years)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2023 (Anticipated)

Primary Completion Date

April 30, 2024 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

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

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG Quadrivalent Seasonal Influenza Vaccine) in healthy infants from 6 months to under 3 years of age(≥ 6 months and < 3 years)

Detailed Description

The study is an Randomized, Double-blind, Active controlled Phase III study.

6. Conditions and Keywords

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

Healthy

Keywords

Influenza, 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

245 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IL-YANG PFS

Arm Type

Experimental

Arm Description

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Arm Title

GSK PFS

Arm Type

Active Comparator

Arm Description

Fluarix Tetra Pre-filled Syringe

Intervention Type

Biological

Intervention Name(s)

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Intervention Description

Teratect Prefilled Syringe Inj. 0.5mL

Intervention Type

Biological

Intervention Name(s)

Fluarix Tetra Pre-filled Syringe

Intervention Description

Fluarix Tetra Pre-filled Syringe 0.5mL

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)

Description

GMT of HI Antibody Titer Before Vaccination and After Vaccination

Time Frame

Up to Day28(+7) after the last vaccination

Title

Geometric Mean Ratio(GMR)

Description

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

6 Months

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy men or women aged from 6 months to < 3 years Subjects were born after full term pregnancy (37 weeks) 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 10 years of age (and for subjects younger than 7 years of age for the some institutions)). Exclusion Criteria: Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components of the study vaccine 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 30 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.

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants

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