HealthyPhase 3NCT02263131
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children
A Phase 3 study testing IL-YANG FLU Vaccine Prefilled Syringe INJ. and VAXIGRIP Prefilled Syringe INJ. in people with Healthy, run by Il-Yang Pharm. Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IL-YANG FLU Vaccine Prefilled Syringe INJ. and VAXIGRIP Prefilled Syringe INJ.
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jun 2014
- 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 6 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)).
Who cannot join
- 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
Show all 13Show fewer
- 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.
About this study
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.
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- IL-YANG FLU Vaccine Prefilled Syringe INJ., VAXIGRIP Prefilled Syringe INJ.
- 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
IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
VAXIGRIP Prefilled Syringe INJ.Biological
VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
| Study group | Role | What they receive |
|---|---|---|
| IL-YANG PFS | Experimental | IL-YANG FLU Vaccine Prefilled Syringe INJ. Receives: Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ. |
| TIV PFS | Active comparator | VAXIGRIP Prefilled Syringe INJ. Receives: Biological: VAXIGRIP Prefilled Syringe INJ. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to Day28(+7)
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),
Measured: up to Day28(+7)
Seroprotection Rate for HI Antibody
Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroprotection
Measured: up to Day28(+7)
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
Measured: up to Day28(+7)
Secondary outcomes (3)
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.
Measured: Day28(+7)
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.
Measured: Day28(+7)
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
Measured: Day28(+7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014
- Study completionJun 2014
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 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
- 416 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, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263131
- Sponsor's protocol ID
- IY_IFEZ_CH_301
- Status last verified
- Aug 2018
- First submitted
- 23 Sep 2014
- Last updated
- 9 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02263131
- Acronym / sponsor ID
- IY_IFEZ_CH_301
- Conditions
- Healthy
- Keywords
- Influenza, Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Posted 6 Apr 2015
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 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.
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 PFS | Experimental | Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.IL-YANG FLU Vaccine Prefilled Syringe INJ. |
| TIV PFS | Active comparator | Biological: VAXIGRIP Prefilled Syringe INJ.VAXIGRIP Prefilled Syringe INJ. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)).
Key exclusion criteria (13 listed)
- 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.
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.IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL | Biological | IL-YANG PFS |
| VAXIGRIP Prefilled Syringe INJ.VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL | Biological | TIV PFS |
Primary outcome
Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion
Time frame: up to Day28(+7)
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
Time frame: up to Day28(+7)
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
Time frame: up to Day28(+7)
Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroprotection
Seroprotection Rate of HI Antibody
Time frame: up to Day28(+7)
Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination
3 secondary outcomes
Geometric Mean Titer* (GMT) of HI Antibody
Time frame: Day28(+7)
GMR of HI Antibody Titer Before Vaccination and After Vaccination
Time frame: Day28(+7)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- 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.
Jin-Han Kang, MD.PhD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IL-YANG FLU Vaccine Prefilled Syringe INJ. and VAXIGRIP Prefilled Syringe INJ. in people with Healthy, run by Il-Yang Pharm. Co., Ltd..
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 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 9 Jul 2020. 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 Apr 2015). 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?
Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion (time frame: up to Day28(+7)). The study lists 4 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 9 Jul 2020.