HealthyPhase 1NCT02111070
Immunogenicity and Safety Study of Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects
A Phase 1 study testing IL-YANG FLU Vaccine 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 Vial INJ.) administered as a single intramuscular injection Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- IL-YANG FLU Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Oct 2012
- Phase
- Phase 1
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males between 20 and 55 years of age at screening
- Body weight of ≥ 55kg and within ±20% of ideal body weight (ideal body weight = (height cm - 100) X 0.9) at screening
- Subjects with no congenital or chronic disease who were considered suitable for the study after screening assessments (investigator's opinion, medical history, physical examination, laboratory test, chest X-ray, and ECG) conducted within 28 days prior to vaccination
- Subjects who were 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
- Subjects with pre-vaccination HI antibody titer ≥ 1:40
- Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL (via ELISA screening or medical history taking)
- Subjects who have concurrent or a past history of immune deficiency disease
- Subject who had participated in blood donation within 1 week prior to vaccination, or are planning to participate in blood donation from Day 1 until Month 7 post-vaccination
- Subject with a history of Guillain-Barre syndrome
- Subject with hemophilia, thrombocytopenia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
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- Subjects who have concurrent or a past history of, malignant tumor of internal organ or blood vessels or skin metastasis
- Subjects with known allergy to a drug, food or latex, who had a history of anaphylaxis
- Subjects who had an acute fever with body temperature > 38.0 Cº within 72 hours prior to administration of the study vaccine or symptoms of suspected acute disease within 14 days prior to administration of the study vaccine
- Subjects who received another experimental drug or vaccine within 28 days before administration of the study vaccine or are planning to receive another experimental drug or vaccine during the study.
- Subjects who had previously received immunoglobulin or blood-derived products within the last 3 months prior to administration of the study vaccine, or are expecting to be treated with immunoglobulin or blood-derived products during the study
- Subjects who had received, or are scheduled to receive, systemic immunosuppressive therapy, radiation therapy or high-dose steroid therapy within the last 6 months prior to administration of the study
- Subjects who had received, or are expected to receive, the medications listed below: Within 28 days prior to administration of the study vaccine: Oriental herbal medicine, Within 14 days prior to administration of the study vaccine: Prescription drugs, Within 7 days prior to administration of the study vaccine: Over-the-counter medicine (including vitamin/mineral supplements)
- Subjects with a history of, or suspected, drug abuse (amphetamine, barbiturates, opioids, benzodiazepines, etc.) based on subject interview and physical examination.
- Subjects with excessive consumption of caffeine (> 5 cups/day) and alcohol (>3 units/day, 1unit= 10g or 12.5ml of pure alcohol), and excessive smoking (>10 cigarettes/day)
- Subject with a known allergy to eggs, chicken, or any components of the study vaccine
- Subjects who in the investigator's opinion, may not be suitable for vaccination or who may interfere with the objective assessment of the study outcomes.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St. Mary's Hospital,The Catholic University of Korea
Seoul
About this study
Official title: Open-label, Phase I Clinical Trial to Assess the Immunogenicity and Safety of the 'IL-YANG Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Vial INJ.) administered as a single intramuscular injection
Read the detailed description
This was an open-label study. Subjects providing voluntary written informed consent underwent protocol-specific assessments and tests within 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria and were considered eligible were sequentially enrolled in the study.
Subjects enrolled in the study received 0.5ml of the study vaccine as an intramuscular injection in the deltoid muscle, and returned to the clinic every day for the first 3 days. On Day 14 post-vaccination, subjects underwent the safety assessments. On Day 28 post-vaccination, subjects returned for safety and immunogenicity assessments.
- Conditions
- Healthy
- Being tested
- IL-YANG FLU Vaccine
- Keywords
- Influenza, Influenza vaccine, Split 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 VaccineBiological
0.5mL
| Study group | Role | What they receive |
|---|---|---|
| ILYANG Inactivated split influenza vaccine | Experimental | IL-YANG FLU Vaccine Vial INJ 0.5mL by intramuscular injection Receives: Biological: IL-YANG FLU Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local & general AE, Unsolicited AE
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 seroprotection for HI antibody after administration of the study vaccine
Seroprotection: HI antibody titer ≥ 1:40 28 days after the administration of the study vaccine
Measured: Day28(+7)
Secondary outcomes (3)
GMT of HI antibody titer before vaccination and after vaccination
GMT(Geometric Mean Titer) and GMR(Geometric Mean Ratio), 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 (vaccination + 28 days) HI antibody titer
Measured: Day28(+7)
Vital signs measurements, physical examination findings, ECG results, and laboratory measurements (hematology, biochemistry and urinalysis)
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 posted10 Apr 2014 (estimated)
- Study startSep 2012
- Primary completionOct 2012
- Study completionOct 2012
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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 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
- NCT02111070
- Sponsor's protocol ID
- IY_IFEZ_101
- Status last verified
- Apr 2014
- First submitted
- 8 Apr 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Phase I Clinical Trial to Assess the Immunogenicity and Safety of the 'IL-YANG Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects
- ClinicalTrials.gov ID
- NCT02111070
- Acronym / sponsor ID
- IY_IFEZ_101
- Conditions
- Healthy
- Keywords
- Influenza, Influenza vaccine, Split influenza vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 10 Apr 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 Vial INJ.) administered as a single intramuscular injection
Detailed description
This was an open-label study. Subjects providing voluntary written informed consent underwent protocol-specific assessments and tests within 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria and were considered eligible were sequentially enrolled in the study.
Subjects enrolled in the study received 0.5ml of the study vaccine as an intramuscular injection in the deltoid muscle, and returned to the clinic every day for the first 3 days. On Day 14 post-vaccination, subjects underwent the safety assessments. On Day 28 post-vaccination, subjects returned for safety and immunogenicity assessments.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILYANG Inactivated split influenza vaccine | Experimental | Biological: IL-YANG FLU VaccineIL-YANG FLU Vaccine Vial INJ 0.5mL by intramuscular injection |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males between 20 and 55 years of age at screening
- Body weight of ≥ 55kg and within ±20% of ideal body weight (ideal body weight = (height cm - 100) X 0.9) at screening
- Subjects with no congenital or chronic disease who were considered suitable for the study after screening assessments (investigator's opinion, medical history, physical examination, laboratory test, chest X-ray, and ECG) conducted within 28 days prior to vaccination
- Subjects who were 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 (17 listed)
- Subjects with pre-vaccination HI antibody titer ≥ 1:40
- Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL (via ELISA screening or medical history taking)
- Subjects who have concurrent or a past history of immune deficiency disease
- Subject who had participated in blood donation within 1 week prior to vaccination, or are 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 Vaccine0.5mL | Biological | ILYANG Inactivated split influenza vaccine |
Primary outcome
Solicited local & general AE, Unsolicited AE
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 seroprotection for HI antibody after administration of the study vaccine
Time frame: Day28(+7)
Seroprotection: HI antibody titer ≥ 1:40 28 days after the administration of the study vaccine
3 secondary outcomes
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 (vaccination + 28 days) HI antibody titer
Time frame: Day28(+7)
Vital signs measurements, physical examination findings, ECG results, and laboratory measurements (hematology, biochemistry and urinalysis)
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 10 Apr 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 1 study testing IL-YANG FLU Vaccine 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 4 inclusion and 17 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 10 Apr 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 AE, Unsolicited AE (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 10 Apr 2014.