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

NCT02330003 | Completed Phase 1

• 1 other identifier: IY_IFEZ_102
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy

Keywords

Influenza; Influenza vaccine; Split influenza vaccine; Seasonal influenza vaccine

Outcome Measures

Primary Outcomes (2)

• 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

  up to Day28(+7)

• 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

  up to Day28(+7)

Secondary Outcomes (7)

• Vital signs

  up to Day28(+7)

• Physical examination

  up to Day28(+7)

• ECG result

  up to Day28(+7)

• Clinical laboratory results

  up to Day28(+7)

• GMT of HI antibody titer before vaccination and after vaccination

  up to Day28(+7)

Study Arms (2)

IL-YANG PFS

EXPERIMENTAL

IL-YANG FLU Vaccine Prefilled Syringe INJ.

Biological: IL-YANG FLU Vaccine Prefilled Syringe INJ.

TIV PFS

ACTIVE COMPARATOR

Fluarix Prefilled Syringe

Biological: Fluarix Prefilled Syringe

Interventions

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

IL-YANG PFS

Fluarix Prefilled Syringe BIOLOGICAL

Fluarix Prefilled Syringe 0.5mL

TIV PFS

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Il-Yang Pharm. Co., Ltd.: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Min Soo Park, M.D,PhD

  Severance Hospital, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 1, 2015
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: January 1, 2015

Record last verified: 2014-12