Influenza, HumanPhase 3NCT03445468
Immunogenicity and Safety for 'IL-YANG Quadrivalent Influenza Vaccine' in Healthy Korean Children and Adolescents
A Phase 3 study testing IL-YANG Quadrivalent Influenza Vaccine and IL-YANG Flu Vaccine Pre-filled Syringe in people with Influenza, Human, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- IL-YANG Quadrivalent Influenza Vaccine and IL-YANG Flu Vaccine Pre-filled Syringe
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Sep 2017to 30 Aug 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The catholic university of Korea, Seoul ST. Marry's Hospital
Seoul, 06591
About this study
Official title: Phase III Study to Evaluate Immunogenicity and Safety of 'Il-Yang Quadrivalent Seasonal Influenza Vaccine' in Healthy Korean Children and Adolescents
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.
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- IL-YANG Quadrivalent Influenza Vaccine, IL-YANG Flu Vaccine Pre-filled Syringe
- Keywords
- Influenza vaccine, Split influenza vaccine, Seasonal 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 Pre-filled SyringeBiological
A single 0.5mL dose administrated as an intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| IL-YANG Quadrivalent Influenza Vaccine | Experimental | The vaccine contains both B strain (Yamagata, Victoria) Receives: Biological: IL-YANG Quadrivalent Influenza Vaccine |
| IL-YANG Flu Vaccine Pre-filled Syringe | Active comparator | The vaccine contains the B/Yamagata strain and it was approved for commercial sale by Ministry of Food and Drug Safety. Receives: Biological: IL-YANG Flu Vaccine Pre-filled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate against Hemagglutination Inhibition(HI) antibody
Seroconversion rate(a lower bound of 95 CI) ≥ 40%
Measured: Up to Day28(+7) after the last vaccination
Seroprotection rate against Hemagglutination
Seroprotection rate(a lower bound of 95 CI) ≥ 70%
Measured: Up to Day28(+7) after the last vaccination
Secondary outcomes (1)
Geometric Mean Titer(GMT) and Geometric Mean Ratio(GMR)
GMT and GMR of HI Antibody Titer Before Vaccination and After Vaccination
Measured: Up to Day28(+7) after the last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start20 Sep 2017
- Primary completion29 Dec 2017
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin-Han Kang, MD.PhD, Principal investigator, The catholic university of Korea, Seoul ST. Marry's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445468
- Sponsor's protocol ID
- IF4CH03
- Status last verified
- Aug 2018
- First submitted
- 8 Aug 2017
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study to Evaluate Immunogenicity and Safety of 'Il-Yang Quadrivalent Seasonal Influenza Vaccine' in Healthy Korean Children and Adolescents
- ClinicalTrials.gov ID
- NCT03445468
- Acronym / sponsor ID
- IF4CH03
- Conditions
- Influenza, Human
- Keywords
- Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2017 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-YANG Quadrivalent Influenza Vaccine | Experimental | Biological: IL-YANG Quadrivalent Influenza VaccineThe vaccine contains both B strain (Yamagata, Victoria) |
| IL-YANG Flu Vaccine Pre-filled Syringe | Active comparator | Biological: IL-YANG Flu Vaccine Pre-filled SyringeThe vaccine contains the B/Yamagata strain and it was approved for commercial sale by Ministry of Food and Drug Safety. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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.
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 Pre-filled SyringeA single 0.5mL dose administrated as an intramuscular injection. | Biological | IL-YANG Flu Vaccine Pre-filled Syringe |
Primary outcome
Seroconversion rate against Hemagglutination Inhibition(HI) antibody
Time frame: Up to Day28(+7) after the last vaccination
Seroconversion rate(a lower bound of 95 CI) ≥ 40%
Seroprotection rate against Hemagglutination
Time frame: Up to Day28(+7) after the last vaccination
Seroprotection rate(a lower bound of 95 CI) ≥ 70%
1 secondary outcome
Geometric Mean Titer(GMT) and Geometric Mean Ratio(GMR)
Time frame: Up to Day28(+7) after the last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- 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.
Jin-Han Kang, MD.PhD principal investigator
The catholic university of Korea, Seoul ST. Marry's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IL-YANG Quadrivalent Influenza Vaccine and IL-YANG Flu Vaccine Pre-filled Syringe in people with Influenza, Human, run by Il-Yang Pharm. Co., Ltd. at 1 site in South Korea.
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 4 inclusion and 13 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 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Seroconversion rate against Hemagglutination Inhibition(HI) antibody (time frame: Up to Day28(+7) after the last vaccination). 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?
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 11 May 2020.