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

NCT02480998 | Completed Phase 1 Results DMC

• 1 other identifier: IY_IFEZ_Q120
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• GMR

  28 days

• GMT

  28 days

Study Arms (2)

IL-YANG Flu Vaccine QIV 0.5mL

EXPERIMENTAL

A single 0.5mL dose administrated as an intramuscular injection.

Biological: IL-YANG Flu Vaccine QIV 0.5mL

IL-YANG Flu Vaccine TIV 0.5mL

ACTIVE COMPARATOR

A single 0.5mL dose administrated as an intramuscular injection.

Biological: IL-YANG Flu Vaccine TIV 0.5mL

Interventions

IL-YANG Flu Vaccine QIV 0.5mL BIOLOGICAL

IL-YANG Flu Vaccine QIV 0.5mL

IL-YANG Flu Vaccine TIV 0.5mL BIOLOGICAL

IL-YANG Flu Vaccine TIV 0.5mL

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

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

Results Point of Contact

• Title: Dr.Dong-suck Lim, CI
• Organization: The catholic university of Korea, Seoul ST. Marry's Hospital

+82-2-2258-7327

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 25, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 11, 2020
• Results First Posted: September 28, 2018

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share