Study to Evaluate the Safety and Immunogenicity of 'IL-YANG Flu Vaccine Quadrivalent Inj' in Healthy Korean Adults

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: IL-YANG Flu Vaccine QIV 0.5mL; Biological: IL-YANG Flu Vaccine TIV 0.5mL

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IL-YANG Flu Vaccine QIV 0.5mL; A single 0.5mL dose administrated as an intramuscular injection.	Biological: IL-YANG Flu Vaccine QIV 0.5mL
Active Comparator: IL-YANG Flu Vaccine TIV 0.5mL; A single 0.5mL dose administrated as an intramuscular injection.	Biological: IL-YANG Flu Vaccine TIV 0.5mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion Rate	Percentage of subjects achieving seroconversion* for HI antibody after vaccination	28 days
Seroprotection Rate	Percentage of subjects achieving seroprotection* for HI antibody after vaccination	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMR	Geometric Mean Ratio of post vaccination HI geometric mean titers	28 days
GMT	Geometric Mean Titer of post vaccination HI geometric mean titers	28 days

Collaborators and Investigators

• Sponsor: Il-Yang Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: IY_IFEZ_Q120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO