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

NCT02111070 | Completed Phase 1

• 1 other identifier: IY_IFEZ_101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Keywords

Influenza; Influenza vaccine; Split influenza vaccine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• GMT of HI antibody titer before vaccination and after vaccination

  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)

Study Arms (1)

ILYANG Inactivated split influenza vaccine

EXPERIMENTAL

IL-YANG FLU Vaccine Vial INJ 0.5mL by intramuscular injection

Biological: IL-YANG FLU Vaccine

Interventions

IL-YANG FLU Vaccine BIOLOGICAL

0.5mL

ILYANG Inactivated split influenza vaccine

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

Study Sites (1)

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

Seoul, South Korea

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• IL-YANG PHARM

  IL-YANG Pharmaceutical Co.,LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: September 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

KR (1)