InfluenzaPhase 3NCT02677493

Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.'

A Phase 3 study testing IL-YANG Quadrivalent Influenza Vaccine, IL-YANG Flu Vaccine Prefilled Syringe and IL-YANG Trivalent Influenza Vaccine in people with Influenza, run by Il-Yang Pharm. Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: IL-YANG Quadrivalent Influenza Vaccine, IL-YANG Flu Vaccine Prefilled Syringe and IL-YANG Trivalent Influenza Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,794 participants
Where: No sites listed yet
Study dates: Oct 2015to Jun 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 18Show fewer

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.

About this study

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

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.

Read the 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.

Conditions: Influenza
Being tested: IL-YANG Quadrivalent Influenza Vaccine, IL-YANG Flu Vaccine Prefilled Syringe, IL-YANG Trivalent Influenza Vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IL-YANG Quadrivalent Influenza VaccineBiological
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Flu Vaccine Prefilled SyringeBiological
A single 0.5mL dose administrated as an intramuscular injection.
IL-YANG Trivalent Influenza VaccineBiological
A single 0.5mL dose administrated as an intramuscular injection.

Study groups in NCT02677493
Study group	Role	What they receive
IL-YANG Quadrivalent Influenza Vaccine	Experimental	The QIV is included both B strain (Yamagata, Victoria). Receives: Biological: IL-YANG Quadrivalent Influenza Vaccine
IL-YANG Flu Vaccine Prefilled Syringe	Active comparator	This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS. Receives: Biological: IL-YANG Flu Vaccine Prefilled Syringe
IL-YANG Trivalent Influenza Vaccine	Active comparator	This TIV is included the B/Victoria strain. Receives: Biological: IL-YANG Trivalent Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 28
Rate of Healthy Adults Aged ≥19 Years With Seroprotection
Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.
Measured: Day 28

Secondary outcomes (6)

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.
Measured: Day 28
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
Measured: Day 28
Geometric Mean Titer as Measured by HI Antibody Titer on Day 28 After Vaccination of the Investigational Product (GMTcomparator/GMTtest Vaccine).
Measured: Day 28
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.
Measured: Day 28
Geometric Mean Titer as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Measured: Day 28
Geometric Mean Ratio as Measured by HI Antibody Titer Before (Day 0) and on Day 28 After Vaccination of the Investigational Product.
Measured: Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Jun 2016

First posted9 Feb 2016 (estimated)
Study startOct 2015
Primary completionJan 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,794 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02677493
Sponsor's protocol ID: IY_IFEZ_Q301
Status last verified: Jul 2020
First submitted: 3 Feb 2016
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02677493
Acronym / sponsor ID: IY_IFEZ_Q301
Conditions: Influenza
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,794 participants (actual)
Lead sponsor: Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2015
Primary completion: Jan 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 9 Feb 2016 (estimated)
Results: Posted 6 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Group A: healthy adults at the age of ≥ 19 and < 65.
Group B: healthy adults at the age of ≥ 65.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
IL-YANG Quadrivalent Influenza Vaccine	Experimental	Biological: IL-YANG Quadrivalent Influenza VaccineThe QIV is included both B strain (Yamagata, Victoria).
IL-YANG Flu Vaccine Prefilled Syringe	Active comparator	Biological: IL-YANG Flu Vaccine Prefilled SyringeThis TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.
IL-YANG Trivalent Influenza Vaccine	Active comparator	Biological: IL-YANG Trivalent Influenza VaccineThis TIV is included the B/Victoria strain.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IL-YANG Quadrivalent Influenza VaccineA single 0.5mL dose administrated as an intramuscular injection.	Biological	IL-YANG Quadrivalent Influenza Vaccine
IL-YANG Flu Vaccine Prefilled SyringeA single 0.5mL dose administrated as an intramuscular injection.	Biological	IL-YANG Flu Vaccine Prefilled Syringe
IL-YANG Trivalent Influenza VaccineA single 0.5mL dose administrated as an intramuscular injection.	Biological	IL-YANG Trivalent Influenza Vaccine

Primary outcome

Rate of Healthy Adults Aged ≥19 Years With Seroconversion
Time frame: Day 28
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
Time frame: Day 28
Seroprotection: A post-vaccination (Day 28) HI antibody titer ≥ 1:40.

6 secondary outcomes

Percentage of Subjects With SCR on Day 28 After Vaccination of the Investigational Product by Age Group
Time frame: Day 28
Rate of Healthy Adults Aged ≥19 ~ <65 Years and ≥65 Years With Seroprotection, Respectively.
Time frame: Day 28
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
Difference of Seroconversion Rate(SCR) of HI Antibody Titer After 28days Vaccination(SCRcomparator-SCRtest Vaccine)
Time frame: Day 28
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
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

Results and safety

Results posted to the registry on 6 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IL-YANG Quadrivalent Influenza Vaccine	1,197	1,186
IL-YANG Flu Vaccine Prefilled Syringe	298	296
IL-YANG Trivalent Influenza Vaccine	299	296

Primary outcome: Rate of Healthy Adults Aged ≥19 Years With Seroconversion

Time frame: Day 28. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	IL-YANG Quadrivalent Influenza Vaccine n = 1175	IL-YANG Flu Vaccine Prefilled Syringe n = 293	IL-YANG Trivalent Influenza Vaccine n = 294
A/H1N1	47.7 (44.9 to 50.6)	49.5 (43.6 to 55.4)	49.0 (43.1 to 54.8)
A/H3N2	78.7 (76.3 to 81.0)	81.6 (76.6 to 85.8)	77.9 (72.7 to 82.5)
B/Yamagata	51.8 (48.9 to 54.7)	54.9 (49.1 to 60.7)	23.1 (18.4 to 28.4)
B/Victoria	47.7 (44.9 to 50.6)	24.2 (19.4 to 29.6)	54.8 (48.9 to 60.5)

Population analysed: The immunogenicity data obtained from the study subjects were analyzed primarily in the Per Protocol Set that was consists of subjects who had at least one dose of the investigational product and from whom post-treatment primary efficacy endpoint data, and have completed the study up to Visit 3 without a major protocol violation.

Primary outcome: Rate of Healthy Adults Aged ≥19 Years With Seroprotection

Time frame: Day 28. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	IL-YANG Quadrivalent Influenza Vaccine n = 1175	IL-YANG Flu Vaccine Prefilled Syringe n = 293	IL-YANG Trivalent Influenza Vaccine n = 294
A/H1N1	88.2 (86.2 to 90.0)	89.4 (85.3 to 92.7)	87.1 (82.7 to 90.7)
A/H3N2	90.0 (88.1 to 91.6)	92.5 (88.9 to 95.2)	89.5 (85.4 to 92.7)
B/Yamagata	86.3 (84.2 to 88.2)	88.4 (84.2 to 91.8)	64.6 (58.9 to 70.1)
B/Victoria	84.9 (82.8 to 86.9)	69.3 (63.7 to 74.5)	85.7 (81.2 to 89.5)

IL-YANG Flu Vaccine Prefilled Syringe: p = 0.09135, ANCOVA

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IL-YANG Quadrivalent Influenza Vaccine	0 of 1,194 (0%)	0 of 1,194 (0%)	Not reported
IL-YANG Flu Vaccine Prefilled Syringe	2 of 298 (0.7%)	0 of 298 (0%)	Not reported
IL-YANG Trivalent Influenza Vaccine	1 of 299 (0.3%)	0 of 299 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Healthy Adults Aged ≥19 Years With Seroconversion (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02677493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.