Back to resultsStudy to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.'
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
IL-YANG Quadrivalent Influenza Vaccine
IL-YANG Flu Vaccine Prefilled Syringe
IL-YANG Trivalent Influenza Vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Influenza
Eligibility Criteria
Inclusion Criteria:
- Healthy men and women at the age of 19 or older.
- Women of childbearing potential must have a negative pregnancy test (urine HCG) at the screening visit.
- Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements.
Exclusion Criteria:
- Subjects with known allergy to eggs, chicken, or any components of the study vaccine.
- Subjects who had received an influenza vaccine within the last 6 months prior to study entry.
- Subjects who have immune function disorders including immunodeficiency diseases or relevant family history.
- Subjects who donated blood within 1 week prior to vaccination or plan to donate blood during the period from Day 1 to Month 7 of vaccination.
- Subjects with a history of Guillain-Barre syndrome.
- Subjects with Down's syndrome or cytogenetic disorders.
- Subjects who are considered by the investigator to have difficulties in study participation due to severe chronic diseases (e.g., cardiovascular diseases except controlled hypertension and respiratory diseases with respiratory failure, metabolic diseases, renal function disorders, hemoglobinopathy, etc.).
- Subjects with hemophilia or coagulation disorder, who are at increased risk of serious bleeding during intramuscular injection.
- Subjects who had an acute fever with body temperature > 38.0 ºC within 72 hours prior to administration of the study vaccine.
- Subjects who had received another vaccine within 28 days before administration of the study vaccine or are planning to receive another vaccine during the study.
Subjects who had received immunosuppressants or immune modifying drugs within 3 months prior to the investigational product vaccination.
- Azathioprine, cyclosporin, interferon, G-CSF, tacrolimus, everolimus, sirolimus, etc.
- High dose corticosteroids (a subject taking high doses, which is defined as 2mg/kg/day or higher of prednisolone administered for longer than 14 consecutive days, is not eligible for this study. The use of inhaled, nasal and topical corticosteroids is allowed, regardless of doses).
- Subjects who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or are scheduled to receive a treatment with blood-derived products during the study.
- Subjects who had participated in another clinical trial within the 30 days before administration of the study vaccine.
Female subjects of childbearing potential who do not agree to use an acceptable method of birth control* for this study during the study period.
- Medically acceptable methods of birth control: condom, injectable or implantable contraceptives, intrauterine device, or oral contraceptives, etc.
- Subjects with other clinically significant medical or psychiatric illness who in the investigator's opinion, are not be suitable for the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
IL-YANG Quadrivalent Influenza Vaccine
IL-YANG Flu Vaccine Prefilled Syringe
IL-YANG Trivalent Influenza Vaccine
Arm Description
The QIV is included both B strain (Yamagata, Victoria).
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
This TIV is included the B/Victoria strain.
Outcomes
Primary Outcome Measures
Rate of Healthy Adults Aged ≥19 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.
Rate of Healthy Adults Aged ≥19 Years With Seroprotection
Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.
Secondary Outcome Measures
Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group
The percentage of subjects with HI antibody SCR on Day 28 after vaccination of the investigational product was calculated and its 95% two-sided CI was presented for each strain by treatment group and by age group. The immunogenicity of the test vaccine was to be demonstrated if the lower limit of the 95% two-sided CI by age group was higher than the above mentioned criteria (40% for < 65 years of age, 30% for ≥ 65 years of age) in each treatment group.
Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.
Seroprotection is defined as follows. subjects who have a post-vaccination (Day 28) HI antibody titer ≥ 1: 40
Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).
Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)
The IL-YANG Quadrivalent Influenza Vaccine contain two types of B strain, while two kinds of Trivalent Influenza Vaccine contain each type of B strain. Primary outcome was about seroconversion and seroprotection rate of HI antibody, so each results of 3 kinds of vaccine was described. Considering the cross-reaction between two types of B strain, the analysis was designed in a way that the SCR/SPR of the B strains can be compared, respectively.
However, secondary outcome, unlike the primary outcome, is expressed as a ratio(difference of seroconversion rate). So, the above factors were not to be consider.
All methods of analysis are comply with the request of MFDS, and the result data that may make you confuse will be delete.
Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Full Information
NCT ID
NCT02677493
First Posted
February 3, 2016
Last Updated
September 26, 2023
Sponsor
Il-Yang Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02677493
Brief Title
Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.'
Official Title
A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Phase III Study to Investigate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.' After Intramuscular Administration in Healthy Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Il-Yang Pharm. Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the immunogenicity and safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.' in healthy male and female adults at the age of 19 or older.
Detailed Description
In this study, only eligible subjects for the study based on the inclusion/exclusion criteria will be randomized to the following stratification groups by age to receive one dose of the test vaccine, comparator 1, or comparator 2.
Group A: healthy adults at the age of ≥ 19 and < 65.
Group B: healthy adults at the age of ≥ 65.
During the study participation, the investigator will assess immunogenicity and safety in subjects. The investigator will perform immunogenicity tests at Visits 1 and 3 (end of study visit) for immunogenicity evaluation (prior to the investigational product vaccination) and instruct subjects to record AEs occurring after the investigational product vaccination for safety assessment.
A blood sample will be collected from a subject who is assigned a subject number. Following an intramuscular injection of 0.5mL investigational product in the deltoid muscle of the shoulder, the subject will have a study visit on Week 4 for blood sampling for antibody titer testing. In addition, a telephone visit will be performed to assess serious AEs (SAEs) up to Day 180 after vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1794 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IL-YANG Quadrivalent Influenza Vaccine
Arm Type
Experimental
Arm Description
The QIV is included both B strain (Yamagata, Victoria).
Arm Title
IL-YANG Flu Vaccine Prefilled Syringe
Arm Type
Active Comparator
Arm Description
This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
Arm Title
IL-YANG Trivalent Influenza Vaccine
Arm Type
Active Comparator
Arm Description
This TIV is included the B/Victoria strain.
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 Prefilled Syringe
Intervention Description
A single 0.5mL dose administrated as an intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
IL-YANG Trivalent Influenza Vaccine
Intervention Description
A single 0.5mL dose administrated as an intramuscular injection.
Primary Outcome Measure Information:
Title
Rate of Healthy Adults Aged ≥19 Years With Seroconversion
Description
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.
Time Frame
Day 28
Title
Rate of Healthy Adults Aged ≥19 Years With Seroprotection
Description
Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group
Description
The percentage of subjects with HI antibody SCR on Day 28 after vaccination of the investigational product was calculated and its 95% two-sided CI was presented for each strain by treatment group and by age group. The immunogenicity of the test vaccine was to be demonstrated if the lower limit of the 95% two-sided CI by age group was higher than the above mentioned criteria (40% for < 65 years of age, 30% for ≥ 65 years of age) in each treatment group.
Time Frame
Day 28
Title
Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.
Description
Seroprotection is defined as follows. subjects who have a post-vaccination (Day 28) HI antibody titer ≥ 1: 40
Time Frame
Day 28
Title
Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).
Time Frame
Day 28
Title
Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)
Description
The IL-YANG Quadrivalent Influenza Vaccine contain two types of B strain, while two kinds of Trivalent Influenza Vaccine contain each type of B strain. Primary outcome was about seroconversion and seroprotection rate of HI antibody, so each results of 3 kinds of vaccine was described. Considering the cross-reaction between two types of B strain, the analysis was designed in a way that the SCR/SPR of the B strains can be compared, respectively.
However, secondary outcome, unlike the primary outcome, is expressed as a ratio(difference of seroconversion rate). So, the above factors were not to be consider.
All methods of analysis are comply with the request of MFDS, and the result data that may make you confuse will be delete.
Time Frame
Day 28
Title
Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Time Frame
Day 28
Title
Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy men and women at the age of 19 or older.
Women of childbearing potential must have a negative pregnancy test (urine HCG) at the screening visit.
Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements.
Exclusion Criteria:
Subjects with known allergy to eggs, chicken, or any components of the study vaccine.
Subjects who had received an influenza vaccine within the last 6 months prior to study entry.
Subjects who have immune function disorders including immunodeficiency diseases or relevant family history.
Subjects who donated blood within 1 week prior to vaccination or plan to donate blood during the period from Day 1 to Month 7 of vaccination.
Subjects with a history of Guillain-Barre syndrome.
Subjects with Down's syndrome or cytogenetic disorders.
Subjects who are considered by the investigator to have difficulties in study participation due to severe chronic diseases (e.g., cardiovascular diseases except controlled hypertension and respiratory diseases with respiratory failure, metabolic diseases, renal function disorders, hemoglobinopathy, etc.).
Subjects with hemophilia or coagulation disorder, who are at increased risk of serious bleeding during intramuscular injection.
Subjects who had an acute fever with body temperature > 38.0 ºC within 72 hours prior to administration of the study vaccine.
Subjects who had received another vaccine within 28 days before administration of the study vaccine or are planning to receive another vaccine during the study.
Subjects who had received immunosuppressants or immune modifying drugs within 3 months prior to the investigational product vaccination.
Azathioprine, cyclosporin, interferon, G-CSF, tacrolimus, everolimus, sirolimus, etc.
High dose corticosteroids (a subject taking high doses, which is defined as 2mg/kg/day or higher of prednisolone administered for longer than 14 consecutive days, is not eligible for this study. The use of inhaled, nasal and topical corticosteroids is allowed, regardless of doses).
Subjects who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or are scheduled to receive a treatment with blood-derived products during the study.
Subjects who had participated in another clinical trial within the 30 days before administration of the study vaccine.
Female subjects of childbearing potential who do not agree to use an acceptable method of birth control* for this study during the study period.
Medically acceptable methods of birth control: condom, injectable or implantable contraceptives, intrauterine device, or oral contraceptives, etc.
Subjects with other clinically significant medical or psychiatric illness who in the investigator's opinion, are not be suitable for the study.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.'
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