HealthyPhase 3NCT04381689
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Infants
A Phase 3 study testing IL-YANG FLU Vaccine Prefilled Syringe INJ. and Fluarix Tetra Pre-filled Syringe in people with Healthy, run by Il-Yang Pharm. Co., Ltd. at 2 sites in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 6 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IL-YANG FLU Vaccine Prefilled Syringe INJ. and Fluarix Tetra Pre-filled Syringe
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Oct 2024to 22 Oct 2025
- 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 6 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 'from 6 months to under 3 years of age (≥6 months and <3 years)
- Born after normal gestation period (which is more than 37 weeks)
- A subject's legally acceptable representative has voluntarily decided on participation and provided written informed consent after receiving and understanding a detailed explanation on this study
Who cannot join
- A history of severe hypersensitivity reactions (e.g., anaphylaxis) to eggs, chicken, and other components of a vaccine including those derived from chicken
- A history of influenza vaccination within 6 months prior to screening
- Immuno dysfunction including immunodeficiency diseases or a family history thereof
- A history of Guillain-Barre syndrome
- Down's syndrome or cytogenetic disorders
- Severe chronic diseases (e.g., cardiovascular diseases excluding controlled hypertension, respiratory diseases with respiratory failure, metabolic diseases, renal dysfunction, hemoglobinopathy, etc.) that, in the opinion of investigator, preclude a subject's participation in the study
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- Risk of serious bleeding from an IM injection such as hemophilia patients or those on anticoagulants
- Acute fever with body temperature exceeding 38.0℃ within 72 hours prior to vaccination with the IP
- Vaccinated with other vaccines within 28 days prior to screening
- Received immunosuppressants or immune-modifying drugs within 3 months prior to screening
- ① Azathioprine, cyclosporin, interferon, granulocyte colony-stimulating factor (G-CSF), tacrolimus, everolimus, sirolimus, etc.
- ② Use of high-dose corticosteroids (e.g., continued use of prednisolone at a dose of ≥2 mg/kg/day in subjects weighing <10 kg for 14 days or longer or at a dose of ≥20 mg/day in subjects weighing ≥10 kg for 14 days or longer). However, inhaled, intranasal, or topical corticosteroids are permitted regardless of their dose.
- Prior use of immunoglobulin or blood products within 3 months prior to screening or their anticipated use during the study
- Took antipyretics, analgesics, or non-steroidal anti-inflammatory drugs (NSAIDs) within 4 hours prior to vaccination with the IP
- Participated in another clinical study within 6 months prior to screening
- Determined ineligible based on other clinically significant medical or psychiatric findings by the investigator
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Korea University ANSAN Hospital
Ansan-si, Gyeonnggi-do, 15355
The Catholic University of Korea, Bucheon St. Mary's Hospital
Bucheon-si, Gyeonnggi-do, 15355
About this study
Official title: Phase Ⅲ, Multi-national, 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)
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)
Read the detailed description
The study is an Randomized, Double-blind, Active controlled Phase III study.
- Conditions
- Healthy
- Being tested
- IL-YANG FLU Vaccine Prefilled Syringe INJ., Fluarix Tetra Pre-filled Syringe
- Keywords
- Influenza, 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 FLU Vaccine Prefilled Syringe INJ.Biological
Teratect Prefilled Syringe Inj. 0.5mL
Fluarix Tetra Pre-filled SyringeBiological
Fluarix Tetra Pre-filled Syringe 0.5mL
| Study group | Role | What they receive |
|---|---|---|
| IL-YANG FLU Vaccine Prefilled Syringe INJ. | Experimental | Teratect Prefilled Syringe Inj. 0.5mL Receives: Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ. |
| GSK FLU Vaccine Prefilled Syringe INJ. | Active comparator | Fluarix Tetra Pre-filled Syringe 0.5mL Receives: Biological: Fluarix Tetra Pre-filled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary immunogenicity endpoints
- (Seroconversion rate† is) Proportion of subjects achieving seroconversion* for HI antibody after vaccination with the IP† † Seroconversion rate (SCR)
- Seroconversion:
- A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer <1:10 and a post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer ≥1:40
- A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer ≥1:10 and at least a 4-fold increase in post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer
- (Seroprotection rate‡ is) Proportion of subjects achieving seroprotection for HI antibody after vaccination with the IP‡ ‡ Seroprotection rate (SPR) Seroprotection: HI antibody titer ≥1:40 at Day 28 after the last vaccination with the IP
Measured: From a pre-vaccination (prior to vaccination with the IP, Visit1) to a post-vaccination (at Day 28 after the last vaccination with the IP)
Seroprotection rate against Hemagglutination
Seroprotection rate(a lower bound of 95 CI) ≥ 70%
Measured: Up to Day28(+7) after the last vaccination
Secondary outcomes (2)
Geometric Mean Titer(GMT)
GMT of HI Antibody Titer Before Vaccination and After Vaccination
Measured: Up to Day28(+7) after the last vaccination
Geometric Mean Ratio(GMR)
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 posted11 May 2020
- Study start23 Oct 2024
- Primary completion20 May 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381689
- Sponsor's protocol ID
- IF4IC03
- Status last verified
- Mar 2026
- First submitted
- 6 May 2020
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅲ, Multi-national, 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)
- ClinicalTrials.gov ID
- NCT04381689
- Acronym / sponsor ID
- IF4IC03
- Conditions
- Healthy
- Keywords
- Influenza, Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 11 May 2020 (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 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.
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 FLU Vaccine Prefilled Syringe INJ. | Experimental | Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.Teratect Prefilled Syringe Inj. 0.5mL |
| GSK FLU Vaccine Prefilled Syringe INJ. | Active comparator | Biological: Fluarix Tetra Pre-filled SyringeFluarix Tetra Pre-filled Syringe 0.5mL |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants 'from 6 months to under 3 years of age (≥6 months and <3 years)
- Born after normal gestation period (which is more than 37 weeks)
- A subject's legally acceptable representative has voluntarily decided on participation and provided written informed consent after receiving and understanding a detailed explanation on this study
Key exclusion criteria (16 listed)
- A history of severe hypersensitivity reactions (e.g., anaphylaxis) to eggs, chicken, and other components of a vaccine including those derived from chicken
- A history of influenza vaccination within 6 months prior to screening
- Immuno dysfunction including immunodeficiency diseases or a family history thereof
- A history of Guillain-Barre syndrome
- 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 FLU Vaccine Prefilled Syringe INJ.Teratect Prefilled Syringe Inj. 0.5mL | Biological | IL-YANG FLU Vaccine Prefilled Syringe INJ. |
| Fluarix Tetra Pre-filled SyringeFluarix Tetra Pre-filled Syringe 0.5mL | Biological | GSK FLU Vaccine Prefilled Syringe INJ. |
Primary outcome
Primary immunogenicity endpoints
Time frame: From a pre-vaccination (prior to vaccination with the IP, Visit1) to a post-vaccination (at Day 28 after the last vaccination with the IP)
1. (Seroconversion rate† is) Proportion of subjects achieving seroconversion* for HI antibody after vaccination with the IP† † Seroconversion rate (SCR) * Seroconversion: * A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer <1:10 and a post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer ≥1:40 * A pre-vaccination (prior to vaccination with the IP, Day 0) HI antibody titer ≥1:10 and at least a 4-fold increase in post-vaccination (at Day 28 after the last vaccination with the IP) HI antibody titer 2. (Seroprotection rate‡ is) Proportion of subjects achieving seroprotection for HI antibody after vaccination with the IP‡ ‡ Seroprotection rate (SPR) Seroprotection: HI antibody titer ≥1:40 at Day 28 after the last vaccination with the IP
Seroprotection rate against Hemagglutination
Time frame: Up to Day28(+7) after the last vaccination
Seroprotection rate(a lower bound of 95 CI) ≥ 70%
2 secondary outcomes
Geometric Mean Titer(GMT)
Time frame: Up to Day28(+7) after the last vaccination
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 8 Jul 2026.
- 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.
2 sites 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 FLU Vaccine Prefilled Syringe INJ. and Fluarix Tetra Pre-filled Syringe in people with Healthy, run by Il-Yang Pharm. Co., Ltd. at 2 sites 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 3 inclusion and 16 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Primary immunogenicity endpoints (time frame: From a pre-vaccination (prior to vaccination with the IP, Visit1) to a post-vaccination (at Day 28 after the last vaccination with the IP)). 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 8 Jul 2026.