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

Primary Purpose

Healthy

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

IL-YANG FLU Vaccine Prefilled Syringe INJ.

VAXIGRIP Prefilled Syringe INJ.

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

Inclusion Criteria:

Healthy men or women aged from 6 months to < 18 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

TIV PFS

Arm Description

IL-YANG FLU Vaccine Prefilled Syringe INJ.

VAXIGRIP Prefilled Syringe INJ.

Outcomes

Primary Outcome Measures

Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion

Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.

Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination

Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2),

Seroprotection Rate for HI Antibody

Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroprotection

Seroprotection Rate of HI Antibody

Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination

Secondary Outcome Measures

Geometric Mean Titer* (GMT) of HI Antibody

Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.

GMR of HI Antibody Titer Before Vaccination and After Vaccination

Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.

Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer

Full Information

NCT ID

NCT02263131

First Posted

September 23, 2014

Last Updated

June 25, 2020

Sponsor

Il-Yang Pharm. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02263131

Brief Title

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

Official Title

Randomized, Double Blind, Active-controlled, Phase Ⅲ Study to Evaluate the Immunogenicity and Safety of 'Ilyang Flu Vaccine Pre-filled Syringe Inj.(Influenza Split Vaccine)' in Healthy Children Aged From 6 Months to < 18 Years.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

October 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Il-Yang Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee

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 FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection.

Detailed Description

This was a multi-center, randomized, double-blind, active-controlled study. Before initiation of any protocol-specific activities, written informed consent was obtained from each patient and their legally acceptable representatives (consent of the legally acceptable representative was required for children younger than 10 years of age, and for the some sites, for children younger than 7 years of age). Subjects who met all of the eligibility criteria after screening assessments as specified in the protocol, were randomized into the test group or the comparator group in a ratio of 5 to 1 according to the pre-generated site-specific randomization table, and received a single dose or two doses of the study vaccine. The investigator performed the efficacy (immunogenicity) and safety assessments throughout the study. Efficacy data were 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 were instructed to record any treatment-emergent adverse event in Patient Diary cards. For all randomized subjects, blood sample was obtained prior to vaccination, and the study vaccine 0.5mL or 0.25mL was administered to the deltoid muscle or anterolateral thigh muscle. For children aged from 6 months to <9 years of age who had not been previously exposed to influenza virus or had not previously received influenza vaccine, another dose of the study vaccine was administered 4 to 5 weeks after the first dose. Blood samples were collected 4 to 5 weeks after the last dose of the study drug for the assessment of antibody titer. All subjects were followed for 6 months after the last dose of the study drug for the safety assessments, and Month 6 follow-up visit was the end-of-study visit.

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

416 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IL-YANG PFS

Arm Type

Experimental

Arm Description

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Arm Title

TIV PFS

Arm Type

Active Comparator

Arm Description

VAXIGRIP Prefilled Syringe INJ.

Intervention Type

Biological

Intervention Name(s)

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Intervention Description

IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL

Intervention Type

Biological

Intervention Name(s)

VAXIGRIP Prefilled Syringe INJ.

Intervention Description

VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL

Primary Outcome Measure Information:

Title

Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion

Description

Time Frame

up to Day28(+7)

Title

Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination

Description

Time Frame

up to Day28(+7)

Title

Seroprotection Rate for HI Antibody

Description

Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroprotection

Time Frame

up to Day28(+7)

Title

Seroprotection Rate of HI Antibody

Description

Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination

Time Frame

up to Day28(+7)

Secondary Outcome Measure Information:

Title

Geometric Mean Titer* (GMT) of HI Antibody

Description

Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.

Time Frame

Day28(+7)

Title

GMR of HI Antibody Titer Before Vaccination and After Vaccination

Description

Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.

Time Frame

Day28(+7)

Title

Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer

Time Frame

Day28(+7)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy men or women aged from 6 months to < 18 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin-Han Kang, MD.PhD

Organizational Affiliation

Seoul St. Mary's Hospital, The Catholic University of Korea

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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