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HealthyPhase 1NCT02330003

Phase 1 Study to Assess the Safety of Inactivated Split Influenza Vaccine and Control Vaccine in Korean Volunteer

A Phase 1 study testing IL-YANG FLU Vaccine Prefilled Syringe INJ. and Fluarix Prefilled Syringe in people with Healthy, run by Il-Yang Pharm. Co., Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study to evaluate the safety of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled Syringe (inactivated split influenza vaccine) after single-dose intramuscular administration. 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 Prefilled Syringe INJ. and Fluarix Prefilled Syringe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
May 2013to Aug 2013
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 male subjects 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)*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 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 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 or thrombocytopenia, or being treated with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection
  • Subjects who have concurrent or a past history of, malignant tumor of internal organ or blood vessels or skin metastasis
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 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 corticosteroid therapy within the last 6 months prior to administration of the study
  • Subjects with a history of, or suspected, drug abuse based on subject interview and physical examination.
  • Subjects with excessive consumption of caffeine and alcohol and excessive smoking
  • 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.

About this study

Official title: A Randomized, Active-Comparator, Open-Label, Phase 1 Clinical Trial to Assess the Safety of the 'IL-YANG Inactivated Split Influenza Vaccine' and Fluarix Prefilled Syringe in Healthy Korean Male Volunteer

The purpose of this study to evaluate the safety of IL-YANG Inactivated Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) in comparison with Fluarix Prefilled Syringe (inactivated split influenza vaccine) after single-dose intramuscular administration.

Read the detailed description

This was a randomized, open-label, active-controlled clinical study. After providing voluntary written informed consent, subjects underwent protocol-specific assessments and tests within the 4 weeks prior to administration of the study vaccine, and those who met all of the inclusion/exclusion criteria were randomized sequentially to the test group or the comparator group according to the pre-generated randomization code. To investigate the safety of the study drug with a two-dose regimen in children, the test group received another dose 28 days after the first dose.

The investigator evaluated the safety and immunogenicity for each subject throughout the study. Safety assessments were performed 28 days after the first dose (Visit 4, End-of-Study Visit) for the comparator group receiving a single-dose regimen of Fluarix Prefilled Syringe, and for the test group receiving a two-dose regimen of the test drug, 28 days after the first dose (Visit 4) and 28 days after the second dose (Visit 6, End-of-Study Visit). Subjects were instructed to record any adverse event occurring after vaccination in the Patient Diary Card. For the immunogenicity assessment, an antibody titer test was performed prior to dosing at Visit 2 (baseline) and 28 days (Visit 4) after the first vaccination for both the test group and comparator group.

Conditions
Healthy
Being tested
IL-YANG FLU Vaccine Prefilled Syringe INJ., Fluarix Prefilled 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

    Second vaccination (only for the test group) of IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL

  • Fluarix Prefilled SyringeBiological

    Fluarix Prefilled Syringe 0.5mL

Study groups in NCT02330003
Study groupRoleWhat they receive
IL-YANG PFSExperimentalIL-YANG FLU Vaccine Prefilled Syringe INJ.
Receives: Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.
TIV PFSActive comparatorFluarix Prefilled Syringe
Receives: Biological: Fluarix Prefilled Syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  2. 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 (7)

  1. Vital signs

    Measured: up to Day28(+7)

  2. Physical examination

    Measured: up to Day28(+7)

  3. ECG result

    Measured: up to Day28(+7)

  4. Clinical laboratory results

    Measured: up to Day28(+7)

  5. GMT of HI antibody titer before vaccination and after vaccination

    Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.

    Measured: up to Day28(+7)

  6. 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: up to Day28(+7)

  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: up to Day28(+7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2015 (estimated)
  2. Study startMay 2013
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02330003
Sponsor's protocol ID
IY_IFEZ_102
Status last verified
Dec 2014
First submitted
29 Dec 2014
Last updated
1 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IL-YANG FLU Vaccine Prefilled Syringe INJ. and Fluarix Prefilled Syringe 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 4 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 1 Jan 2015. 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 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 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?

On the ClinicalTrials.gov record for NCT02330003.

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 1 Jan 2015.

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