HealthyPhase 3NCT02154308
Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Adults
A Phase 3 study testing IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL in people with Healthy, run by Il-Yang Pharm. Co., Ltd. at 1 site 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 FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 787 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Aug 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy man and woman 18 years of age or older
- Woman of childbearing potential must have a negative urine human chorionic gonadotropin (HCG) test at screening
- Subject who was given, and fully understood, the information about the study, made a voluntary decision, and provided written informed consent, to participate in the study and comply with all applicable study requirements.
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 who had participated in blood donation within 1 week prior to vaccination, or is planning to participate in blood donation from Day 1 until Month 7 post-vaccination.
- Subject with a history of Guillain-Barre syndrome
- Subject with Down's syndrome or cytogenetic disorders.
Show all 16Show fewer
- Subject with severe chronic disease which in the investigator's opinion would not make the subject a good candidate for the clinical trial
- 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 received any product containing acetylsalicylic acid or aspirin within 14 days 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
- Woman of childbearing potential at screening or woman who plans to become pregnant during the study. A woman of childbearing potential must have a negative pregnancy test, and, unless surgically sterile, must use an effective method of contraception throughout the study to be eligible for the study. Periodic abstinence and withdrawal are not considered as acceptable methods of contraception. Use of hormonal contraceptives is not allowed.
- 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
Incheon St. Mary's Hospital, The Catholic University of Korea etc, Total 10 hospitals.
Seoul Etc
About this study
Official title: A Multicenter, Open-Label, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of IL-YANG Inactivated Split Influenza Vaccine in Healthy Adults 18 to < 65 Years of Age and in Healthy Adults ≥ 65 Years of Age.
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 is a multicenter, open-label study. Subjects who have provided written informed consent will undergo the protocol-specific assessments to determine their eligibility for the study. Subjects considered eligible will be assigned to an appropriate age stratum, and will be given a single dose of the study vaccine. For each age stratum, the first 142 subjects enrolled will be evaluated for both immunogenicity and safety, and the remaining subjects subsequently enrolled will be evaluated only for the safety of the study vaccine.
- Group A: healthy adults 18 to < 65 years of age
- Group B: healthy adults ≥ 65 years of age
The investigator will evaluate the immunogenicity and safety of the study vaccine throughout the study. The immunogenicity assessment will be performed at Visit 1 (pre-vaccination) and at the End-of-Study Visit. For safety measurements, subjects will be instructed to record any adverse events occurring after vaccination in the Patient Diary card.
Subjects who are assigned for the both immunogenicity and safety assessment will have their blood sample drawn for antibody titer (immunogenicity) testing, and afterward, receive 0.5 mL of the study vaccine by intramuscular injection at deltoid muscle. Subjects will return to the clinic for follow-up visit 4 to 5 weeks after the vaccination, and undergo another blood sampling for antibody titer test. The long-term safety for up to 6 months after vaccination will be also evaluated. Subjects who are assigned for only safety assessments will not undergo blood sampling, but have the same visit schedule as those assigned for the both immunogenicity and safety assessments.
- Conditions
- Healthy
- Being tested
- IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL
- 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 0.5mLBiological
IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| IL-YANG influenza vaccine | Experimental | IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection Receives: Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local & general Adverse Event, Unsolicited Adverse Event
Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia
Measured: up to Day28(+7)
Percentage of subjects achieving seroconversion and seroprotection for HI antibody after administration of the study vaccine
Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-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 (Day 28) HI antibody titer (Case 2).
Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40
Measured: up to Day28(+7)
Secondary outcomes (3)
Physical examination finding, vital signs
Measured: Day28(+7)
Geometric Mean Titer (GMT) of HI antibody titer before vaccination and after vaccination
Geometric Mean Titer (GMT) and 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)
Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40, and a 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 posted3 Jun 2014 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionAug 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- IL-YANG PHARM, Study director, IL-YANG Pharmaceutical Co.,LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154308
- Sponsor's protocol ID
- IY_IFEZ_AD_301
- Status last verified
- Jun 2014
- First submitted
- 30 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of IL-YANG Inactivated Split Influenza Vaccine in Healthy Adults 18 to < 65 Years of Age and in Healthy Adults ≥ 65 Years of Age.
- ClinicalTrials.gov ID
- NCT02154308
- Acronym / sponsor ID
- IY_IFEZ_AD_301
- Conditions
- Healthy
- Keywords
- Influenza, Influenza vaccine, Split influenza vaccine, Seasonal influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 787 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 3 Jun 2014 (estimated)
- 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 FLU Vaccine Prefilled Syringe INJ.) administered as a single intramuscular injection.
Detailed description
This is a multicenter, open-label study. Subjects who have provided written informed consent will undergo the protocol-specific assessments to determine their eligibility for the study. Subjects considered eligible will be assigned to an appropriate age stratum, and will be given a single dose of the study vaccine. For each age stratum, the first 142 subjects enrolled will be evaluated for both immunogenicity and safety, and the remaining subjects subsequently enrolled will be evaluated only for the safety of the study vaccine.
- Group A: healthy adults 18 to < 65 years of age
- Group B: healthy adults ≥ 65 years of age
The investigator will evaluate the immunogenicity and safety of the study vaccine throughout the study. The immunogenicity assessment will be performed at Visit 1 (pre-vaccination) and at the End-of-Study Visit. For safety measurements, subjects will be instructed to record any adverse events occurring after vaccination in the Patient Diary card.
Subjects who are assigned for the both immunogenicity and safety assessment will have their blood sample drawn for antibody titer (immunogenicity) testing, and afterward, receive 0.5 mL of the study vaccine by intramuscular injection at deltoid muscle. Subjects will return to the clinic for follow-up visit 4 to 5 weeks after the vaccination, and undergo another blood sampling for antibody titer test. The long-term safety for up to 6 months after vaccination will be also evaluated. Subjects who are assigned for only safety assessments will not undergo blood sampling, but have the same visit schedule as those assigned for the both immunogenicity and safety assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IL-YANG influenza vaccine | Experimental | Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mLIL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy man and woman 18 years of age or older
- Woman of childbearing potential must have a negative urine human chorionic gonadotropin (HCG) test at screening
- Subject who was given, and fully understood, the information about the study, made a voluntary decision, and provided written informed consent, to participate in the study and comply with all applicable study requirements.
Key exclusion criteria (16 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 who had participated in blood donation within 1 week prior to vaccination, or is planning to participate in blood donation from Day 1 until Month 7 post-vaccination.
- Subject 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 FLU Vaccine Prefilled Syringe INJ 0.5mLIL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection | Biological | IL-YANG influenza vaccine |
Primary outcome
Solicited local & general Adverse Event, Unsolicited Adverse Event
Time frame: up to Day28(+7)
Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia
Percentage of subjects achieving seroconversion and seroprotection for HI antibody after administration of the study vaccine
Time frame: up to Day28(+7)
Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-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 (Day 28) HI antibody titer (Case 2). Seroprotection: post-vaccination (Day 28) HI antibody titer ≥ 1:40
3 secondary outcomes
Physical examination finding, vital signs
Time frame: Day28(+7)
Geometric Mean Titer (GMT) of HI antibody titer before vaccination and after vaccination
Time frame: Day28(+7)
Percentage of subjects with a pre-vaccination (Day 0) HI antibody titer < 1:40, and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer
Time frame: Day28(+7)
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 3 Jun 2014.
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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.
IL-YANG PHARM study director
IL-YANG Pharmaceutical Co.,LTD
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 FLU Vaccine Prefilled Syringe INJ 0.5mL in people with Healthy, 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 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 3 Jun 2014. 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?
Solicited local & general Adverse Event, Unsolicited Adverse Event (time frame: up to Day28(+7)). 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 3 Jun 2014.