Immunogenicity and Safety Study of Inactivated Split Influenza Vaccine' in Healthy Korean Male Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: IL-YANG FLU Vaccine

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital,The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ILYANG Inactivated split influenza vaccine; IL-YANG FLU Vaccine Vial INJ 0.5mL by intramuscular injection	Biological: IL-YANG FLU Vaccine; 0.5mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited local & general AE, Unsolicited AE	Solicited local reaction: pain, tenderness, redness, swelling Solicited general reactions: fever, nausea/vomiting, diarrhea, headache, fatigue, myalgia	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	Day28(+7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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		Day28(+7)
Vital signs measurements, physical examination findings, ECG results, and laboratory measurements (hematology, biochemistry and urinalysis)		Day28(+7)

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (ESTIMATE): April 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): April 10, 2014
• Last Update Submitted That Met QC Criteria: April 9, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Influenza; Influenza vaccine; Split influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: IY_IFEZ_101