Influenza, HumanPhase 1/2NCT02480998
Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults
A Phase 1/2 study testing IL-YANG Flu Vaccine QIV 0.5mL and IL-YANG Flu Vaccine TIV 0.5mL in people with Influenza, Human, run by Il-Yang Pharm. Co., Ltd..
Trial summary
This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to < 65 years of age. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- IL-YANG Flu Vaccine QIV 0.5mL and IL-YANG Flu Vaccine TIV 0.5mL
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Apr 2015
- Phase
- Phase 1/2
- 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 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women 19 to < 65 years of age at screening
- Body weight within ±20% of ideal body weight at screening
- Women of childbearing potential must have a negative serum beta-hCG at visit 2; and agree to use a proper contraceptive method for 1 month after vaccination (starting from 3 months before screening), using a medication or device that does not have any drug-interaction with the investigational product.
- 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 no later than 28 days prior to vaccination
- Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements
Who cannot join
- Subject with known allergy to eggs, chicken, or any components of the investigational product
- Subjects who had received an influenza vaccine within the last 6 months prior to study entry
- Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL
- Subjects who have concurrent or a past history of, immune deficiency disease
- Subject with a history of Guillain-Barre syndrome
- Subject with hemophilia or thrombocytopenia or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
Show all 15Show fewer
- 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 investigational product or symptoms of suspected acute disease within 14 days prior to administration of the investigational product
- Subjects who had received another vaccine within 28 days before administration of the investigational product or are planning to receive another vaccine during the study.
- Subjects who had participated in another clinical trial within the 30 days before administration of the investigational product.
- Subjects who had previously received blood-derived products (including immunoglobulin) within the last 3 months prior to administration of the Investigational product, or are scheduled to receive a treatment with 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 with a history of drug abuse within the last 6 months prior to vaccination, or is suspected of drug abuse
- Subjects with excessive consumption of caffeine, alcohol, or tobacco
- Subjects with other clinically significant medical or psychiatric illness who in the investigator's opinion, are not be suitable for the study
About this study
Official title: A Randomized, Double-blind, Active Comparator, Phase I/Ⅱa Clinical Trial to Assess the Safety and Immunogenicity of the 'IL-YANG Flu Vaccine Quadrivalent Inj.' in Healthy Korean Adult Subjects
This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to < 65 years of age.
Read the detailed description
This is a randomized, double-blind, active-controlled, phase I/Ⅱa clinical trial.
During the Part A phase, all safety data collected from the 12 subjects enrolled in the Part A phase will be analyzed to determine the safety and tolerability of the investigational product, which should include any solicited and unsolicited adverse drug reactions occurring for the first 7 days after vaccination and any adverse events occurring for 28 days after vaccination. Antibody titer test will be also performed to evaluate the efficacy (immunogenicity) of the investigational product. During the Part B phase, a total of 72 subjects will be enrolled, and all safety data (including all adverse events) and immunogenicity data will be analyzed.
- Conditions
- Influenza, Human
- Being tested
- IL-YANG Flu Vaccine QIV 0.5mL, IL-YANG Flu Vaccine TIV 0.5mL
- 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 QIV 0.5mLBiological
IL-YANG Flu Vaccine TIV 0.5mLBiological
| Study group | Role | What they receive |
|---|---|---|
| IL-YANG Flu Vaccine QIV 0.5mL | Experimental | A single 0.5mL dose administrated as an intramuscular injection. Receives: Biological: IL-YANG Flu Vaccine QIV 0.5mL |
| IL-YANG Flu Vaccine TIV 0.5mL | Active comparator | A single 0.5mL dose administrated as an intramuscular injection. Receives: Biological: IL-YANG Flu Vaccine TIV 0.5mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion Rate
Percentage of subjects achieving seroconversion* for HI antibody after vaccination
Measured: 28 days
Seroprotection Rate
Percentage of subjects achieving seroprotection* for HI antibody after vaccination
Measured: 28 days
Secondary outcomes (2)
GMR
Geometric Mean Ratio of post vaccination HI geometric mean titers
Measured: 28 days
GMT
Geometric Mean Titer of post vaccination HI geometric mean titers
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2015
- Study completionApr 2015
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 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
- NCT02480998
- Sponsor's protocol ID
- IY_IFEZ_Q120
- Status last verified
- Jul 2020
- First submitted
- 11 Jun 2015
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Comparator, Phase I/Ⅱa Clinical Trial to Assess the Safety and Immunogenicity of the 'IL-YANG Flu Vaccine Quadrivalent Inj.' in Healthy Korean Adult Subjects
- ClinicalTrials.gov ID
- NCT02480998
- Acronym / sponsor ID
- IY_IFEZ_Q120
- Conditions
- Influenza, Human
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Il-Yang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 28 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the safety, tolerability and immunogenicity of IL-YANG quadrivalent vaccine versus IL-YANG trivalent vaccine after a single intramuscular administration in healthy Korean males and females 19 to < 65 years of age.
Detailed description
This is a randomized, double-blind, active-controlled, phase I/Ⅱa clinical trial.
During the Part A phase, all safety data collected from the 12 subjects enrolled in the Part A phase will be analyzed to determine the safety and tolerability of the investigational product, which should include any solicited and unsolicited adverse drug reactions occurring for the first 7 days after vaccination and any adverse events occurring for 28 days after vaccination. Antibody titer test will be also performed to evaluate the efficacy (immunogenicity) of the investigational product. During the Part B phase, a total of 72 subjects will be enrolled, and all safety data (including all adverse events) and immunogenicity data will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-YANG Flu Vaccine QIV 0.5mL | Experimental | Biological: IL-YANG Flu Vaccine QIV 0.5mLA single 0.5mL dose administrated as an intramuscular injection. |
| IL-YANG Flu Vaccine TIV 0.5mL | Active comparator | Biological: IL-YANG Flu Vaccine TIV 0.5mLA single 0.5mL dose administrated as an intramuscular injection. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy men and women 19 to < 65 years of age at screening
- Body weight within ±20% of ideal body weight at screening
- Women of childbearing potential must have a negative serum beta-hCG at visit 2; and agree to use a proper contraceptive method for 1 month after vaccination (starting from 3 months before screening), using a medication or device that does not have any drug-interaction with the investigational product.
- 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 no later than 28 days prior to vaccination
- Subjects who were given, and fully understood, the information about the study, and have provided voluntary written informed consent to participate in the study and to comply with all applicable study requirements
Key exclusion criteria (15 listed)
- Subject with known allergy to eggs, chicken, or any components of the investigational product
- Subjects who had received an influenza vaccine within the last 6 months prior to study entry
- Subjects who have known or suspected infection with HAV, HBV, HCV, HIV or VDRL
- Subjects who have concurrent or a past history of, immune deficiency disease
- 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 QIV 0.5mL | Biological | IL-YANG Flu Vaccine QIV 0.5mL |
| IL-YANG Flu Vaccine TIV 0.5mL | Biological | IL-YANG Flu Vaccine TIV 0.5mL |
Primary outcome
Seroconversion Rate
Time frame: 28 days
Percentage of subjects achieving seroconversion* for HI antibody after vaccination
Seroprotection Rate
Time frame: 28 days
Percentage of subjects achieving seroprotection* for HI antibody after vaccination
2 secondary outcomes
GMR
Time frame: 28 days
GMT
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IL-YANG Flu Vaccine QIV 0.5mL and IL-YANG Flu Vaccine TIV 0.5mL in people with Influenza, Human, 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 5 inclusion and 15 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 Aug 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 28 Sep 2018). 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?
Seroconversion Rate (time frame: 28 days). 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 Aug 2020.